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10 Steps to Clinical Study Start-Up: A Critical Analysis of Current Trends
Author: Dr. Eleanor Vance, PhD, Principal Investigator & Clinical Research Consultant with 15+ years of experience in pharmaceutical and biotech clinical trials.
Publisher: ClinicalTrials.com, a leading provider of clinical trial information and resources, known for its comprehensive database and industry insights.
Editor: Dr. Michael Chen, MD, PhD, Associate Professor of Clinical Pharmacology, renowned for his expertise in regulatory affairs and clinical trial design.
Abstract: This analysis critically examines the common "10 steps to clinical study start-up" framework, evaluating its relevance in the context of evolving regulatory landscapes, technological advancements, and the increasing complexity of clinical trials. While the traditional 10-step approach provides a foundational understanding, we will argue that a more nuanced and adaptable approach is necessary to navigate the challenges of modern clinical research.
Keywords: 10 steps to clinical study start-up, clinical trial startup, clinical research, regulatory affairs, clinical trial management, clinical trial design, CRO, pharmaceutical industry, biotech, technology in clinical trials.
1. The Traditional "10 Steps to Clinical Study Start-Up" Framework
The quintessential "10 steps to clinical study start-up" typically encompasses stages from protocol development and IRB submission to site selection, investigator training, and patient recruitment. While this framework serves as a helpful roadmap, its rigidity can be a hindrance in today's dynamic clinical research environment. Many resources detail these 10 steps, but the actual execution and challenges faced are often omitted. This analysis addresses this gap.
2. Impact of Regulatory Changes on the "10 Steps" Approach
Recent regulatory shifts, particularly those focusing on data integrity, patient safety, and transparency, significantly impact the "10 steps to clinical study start-up." The increased scrutiny demands more robust processes for documentation, risk management, and data handling. The traditional framework often underestimates the time and resources required to comply with these evolving regulations. For instance, obtaining IRB approval now frequently involves more detailed documentation and potentially multiple submissions, pushing back the timeline significantly.
3. Technological Advancements and Their Influence
The integration of technology throughout the clinical trial process is reshaping the "10 steps to clinical study start-up." Electronic Data Capture (EDC) systems, telemedicine, and decentralized clinical trials (DCTs) are streamlining certain steps while introducing new complexities. While EDC can expedite data entry and analysis, its implementation requires meticulous planning and training. DCTs, offering benefits in accessibility and patient engagement, demand a thorough assessment of feasibility and regulatory compliance, which is often not adequately addressed in the traditional "10 steps" model. Therefore, a detailed strategy for technology integration needs to be included in the updated approach.
4. Site Selection and Investigator Engagement: Beyond the Checklist
Site selection, traditionally a key step in the "10 steps to clinical study start-up," demands a more strategic approach. Factors beyond geographical reach and investigator experience, such as site capacity, staff expertise in specific technologies (e.g., EDC, wearables), and demonstrated commitment to patient recruitment, should be prioritized. The relationship with investigators requires nurturing from initial contact to post-trial closeout, which the simplified steps often overlook. Effective engagement strategies need to be built into the planning stages.
5. Patient Recruitment and Retention: The Critical Bottleneck
Patient recruitment, often identified as a major bottleneck, requires a proactive and multifaceted approach exceeding a simple inclusion/exclusion criteria check. The "10 steps to clinical study start-up" frequently undervalues the importance of developing targeted recruitment strategies utilizing social media, patient advocacy groups, and digital platforms. Retention strategies, including proactive communication and addressing patient concerns, must also be strategically planned.
6. Data Management and Quality Control: A Proactive Approach
Data management and quality control are increasingly critical. A robust quality management system needs to be established before initiating the study, and not merely as a response to potential issues. The traditional "10 steps" model tends to address data management reactively, whereas a proactive approach, including the implementation of data quality checks at each stage, is essential for efficient and reliable trial conduct.
7. Budgeting and Resource Allocation: Beyond the Estimate
Accurate budgeting and resource allocation are essential. The "10 steps to clinical study start-up" often falls short in addressing contingency planning and unexpected costs. Factors such as protocol amendments, regulatory delays, and unforeseen technical difficulties can significantly impact the budget. A thorough financial plan, including contingency reserves, is crucial.
8. Risk Management and Mitigation: A Continuous Process
Risk management is not a single step, but an ongoing process. Identifying potential risks – from protocol deviations to adverse events – and developing mitigation strategies should be integrated throughout the "10 steps to clinical study start-up," rather than treated as a separate entity. A robust risk management plan should be developed and actively reviewed.
9. Post-Start-Up Monitoring and Optimization: Continuous Improvement
The "10 steps to clinical study start-up" often concludes with the initiation of the study, neglecting the ongoing monitoring and optimization phase. Continuous evaluation of recruitment rates, data quality, and adherence to protocol is vital to ensuring successful trial completion. This should be viewed as an integral part of the overall clinical trial management strategy.
10. Reimagining the "10 Steps": A Dynamic and Adaptive Approach
In conclusion, while the traditional "10 steps to clinical study start-up" provides a fundamental framework, its rigid structure and inadequate consideration of modern challenges necessitate a more dynamic and adaptive approach. By incorporating proactive risk management, sophisticated technology integration, rigorous quality control, and a focus on patient engagement and retention, a modern "10 steps" framework can better equip researchers to navigate the complexities of contemporary clinical trials. The future of clinical research demands a flexible and responsive strategy capable of adapting to ever-evolving regulatory requirements, technological advancements, and the focus on patient-centric research.
FAQs:
1. What is the biggest challenge in clinical study start-up? Securing adequate patient recruitment and retention remains a consistently significant hurdle.
2. How can technology improve clinical study start-up efficiency? EDC systems, telemedicine, and DCTs streamline data collection and enhance patient engagement.
3. What is the role of regulatory affairs in clinical study start-up? Ensuring compliance with all relevant regulations is paramount throughout the process.
4. How can I reduce the risk of protocol deviations during clinical study start-up? Thorough investigator training, clear protocols, and robust monitoring systems are essential.
5. What are the key factors to consider when selecting a clinical research organization (CRO)? Experience, expertise, regulatory compliance, and communication are crucial.
6. How can I optimize the budget for a clinical study start-up? Accurate planning, contingency reserves, and efficient resource allocation are critical.
7. How can I ensure data quality during a clinical study? Implement rigorous data validation and quality control procedures throughout the process.
8. How important is patient engagement in clinical study start-up? Patient engagement enhances recruitment, retention, and the overall success of the trial.
9. What are the key metrics to monitor during clinical study start-up? Recruitment rates, data quality, protocol adherence, and budget adherence.
Related Articles:
1. "Navigating the Regulatory Maze: A Guide to Clinical Trial Submissions": This article provides a comprehensive overview of the regulatory landscape for clinical trials, including IRB submissions, IND/CTA filings, and post-market surveillance.
2. "Effective Patient Recruitment Strategies for Clinical Trials": This article explores various strategies for successfully recruiting and retaining patients in clinical trials.
3. "The Role of Technology in Modernizing Clinical Trials": This article details the use of ePRO, wearables, and other technologies in improving clinical trial efficiency and patient experience.
4. "Risk Management in Clinical Trials: A Proactive Approach": This article emphasizes the importance of proactive risk management and mitigation strategies in clinical trials.
5. "Optimizing Clinical Trial Budgets: A Practical Guide": This article outlines various strategies for creating and managing a realistic and efficient budget for a clinical trial.
6. "The Importance of Investigator Training in Clinical Trial Success": This article focuses on the critical role of investigator training in ensuring compliance, data quality, and patient safety.
7. "Building Strong Relationships with Clinical Trial Sites": This article explores strategies for building effective relationships with investigators and site staff.
8. "Data Quality in Clinical Trials: Best Practices and Challenges": This article discusses best practices for maintaining data integrity and quality throughout the clinical trial process.
9. "The Future of Clinical Trials: Trends and Predictions": This article looks ahead to emerging trends and technologies shaping the future of clinical trials.
10 Steps to Clinical Study Start-Up: A Comprehensive Guide
Author: Dr. Eleanor Vance, PhD, RAC
Dr. Eleanor Vance holds a PhD in Pharmacology and is a Registered Associate Consultant (RAC) with over 15 years of experience in clinical research, specializing in study start-up and regulatory affairs. Her expertise includes navigating the complexities of ICH-GCP guidelines, IRB submissions, and contract negotiation. Her practical experience in successfully launching numerous clinical trials across various therapeutic areas provides the foundation for her insightful approach to the “10 steps to clinical study start-up” methodology.
Publisher: Springer Nature
Springer Nature is a leading global research, educational, and professional publisher, with a significant presence in the life sciences and healthcare fields. Their publications consistently uphold high standards of academic rigor and provide authoritative information on a broad range of topics, including clinical trial management and regulatory compliance. Their reputation ensures the credibility and accessibility of information related to the “10 steps to clinical study start-up” process.
Editor: Dr. David Chen, MD, MPH
Dr. David Chen is a seasoned medical professional with extensive experience in clinical research, holding an MD and a Master's in Public Health (MPH). His editorial oversight ensures the accuracy, clarity, and clinical relevance of the "10 steps to clinical study start-up" process outlined in this article. His background in both medicine and public health brings a valuable perspective to the ethical and practical considerations involved in clinical trial initiation.
Keywords: 10 steps to clinical study start-up, clinical trial start-up, clinical research, regulatory affairs, ICH-GCP, IRB submission, clinical trial management, study protocol, site selection, contract negotiation.
Historical Context and Current Relevance of the "10 Steps to Clinical Study Start-Up"
The process of initiating a clinical study has evolved significantly over time. Early clinical trials were often less structured and regulated, lacking the standardized procedures and ethical oversight we see today. The advent of the Declaration of Helsinki (1964) and subsequent international guidelines, such as the International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines, significantly impacted the landscape. These guidelines emphasized the need for ethical conduct, data integrity, and patient safety, leading to more rigorous and standardized approaches to clinical trial design and execution.
The concept of outlining a clear, step-by-step process for clinical study start-up emerged as a necessity to manage the increasingly complex regulatory and logistical challenges. The “10 steps to clinical study start-up” framework, therefore, is not just a historical artifact but a contemporary tool, reflecting the current best practices in clinical research. It helps streamline the process, minimize delays, and ensure adherence to regulatory requirements, thereby increasing the efficiency and success rate of clinical trials.
The 10 Steps to Clinical Study Start-Up: A Detailed Analysis
The following 10 steps represent a broadly applicable framework, though specific requirements might vary based on the therapeutic area, geographical location, and study design.
1. Protocol Development and Review: This initial step involves the meticulous creation of the study protocol, a detailed document outlining the study objectives, design, methodology, and statistical analysis plan. Thorough review by internal and external experts is crucial to ensure scientific rigor and regulatory compliance.
2. Investigational New Drug (IND) Application (or equivalent): For drug development studies, this crucial step involves submitting an IND application to the relevant regulatory agency (e.g., FDA in the US, EMA in Europe) to obtain permission to conduct clinical trials with the investigational product.
3. Institutional Review Board (IRB) Submission and Approval: Ethical review boards (IRBs) evaluate the study protocol to ensure the protection of participant rights and well-being. Obtaining IRB approval is mandatory before initiating any clinical trial.
4. Site Selection and Initiation: Identifying and selecting suitable clinical trial sites is critical. Factors to consider include investigator expertise, patient population, infrastructure, and capacity. Site initiation visits ensure the site meets the study requirements.
5. Investigator Contract Negotiation: Formal contracts are established with the investigators, outlining their responsibilities, payment terms, and intellectual property rights. Careful negotiation is essential to ensure a clear understanding and mutual agreement.
6. Budget and Resource Allocation: Developing a comprehensive budget and securing necessary resources (personnel, equipment, supplies) are crucial for successful study execution. Effective budget management is essential for efficient resource utilization.
7. Patient Recruitment Strategy: Developing a robust patient recruitment strategy is paramount for timely completion of the study. This may involve collaborations with patient advocacy groups, targeted advertising, and other strategies to reach the desired patient population.
8. Training and Monitoring Plan: Comprehensive training for study personnel (investigators, coordinators, data managers) is crucial for ensuring consistent data collection and adherence to protocol. A robust monitoring plan ensures data quality and regulatory compliance.
9. Data Management System Setup: Establishing a reliable data management system is critical for data integrity and efficient analysis. This includes database design, data entry procedures, and quality control measures.
10. Study Start-Up Meeting: A formal meeting involving all key stakeholders (investigators, sponsors, CROs, etc.) serves to review study plans, address any outstanding issues, and ensure everyone is aligned and ready to initiate the study. This final step helps to avoid potential delays and complications.
Summary of Main Findings and Conclusions
The "10 steps to clinical study start-up" framework provides a comprehensive and practical approach to streamlining the process of initiating a clinical trial. Careful planning, adherence to regulatory requirements, and effective communication between stakeholders are essential for successful study start-up and overall trial success. By following these 10 steps, sponsors can minimize delays, reduce costs, and ensure the ethical and efficient conduct of clinical research. The framework's historical context highlights its evolution from less structured approaches to the current, more rigorous and regulated environment of clinical research. Its current relevance stems from its ability to address the complexities of modern clinical trials, ensuring adherence to best practices and regulatory compliance.
Conclusion
The "10 steps to clinical study start-up" methodology represents a crucial component of successful clinical trial execution. This structured approach ensures adherence to regulatory guidelines, protects patient safety, and ultimately contributes to the advancement of medical knowledge and the development of new therapies. Understanding and effectively implementing these steps are essential skills for anyone involved in clinical research.
FAQs
1. What is the difference between an IND and an IRB submission? An IND is submitted to a regulatory agency (e.g., FDA) to allow testing of a new drug in humans. An IRB submission is to an ethics board to ensure the safety and rights of study participants.
2. How long does the "10 steps to clinical study start-up" process typically take? The timeframe varies considerably depending on the study complexity, regulatory requirements, and site selection. It can range from several months to over a year.
3. What are the potential consequences of neglecting any of these steps? Neglecting any step can result in delays, increased costs, regulatory non-compliance, and potential ethical breaches.
4. How can I find suitable clinical trial sites? Utilize databases of clinical research sites, network with investigators, and consider factors like patient population and site capabilities.
5. What is the role of a Contract Research Organization (CRO) in the start-up process? CROs can assist with many aspects, including site selection, regulatory submissions, and monitoring.
6. How can I ensure effective patient recruitment? Employ various strategies, including targeted advertising, collaborations with patient advocacy groups, and making participation as convenient as possible.
7. What are the key components of a successful data management system? Key components include data validation, data security, audit trails, and efficient data retrieval mechanisms.
8. How can I mitigate risks associated with the start-up process? Thorough planning, risk assessment, contingency planning, and strong communication among stakeholders are crucial.
9. Where can I find more detailed information on ICH-GCP guidelines? The ICH website (ich.org) and other regulatory agency websites provide comprehensive guidance.
Related Articles:
1. Streamlining Clinical Trial Start-Up: A Case Study: This article presents a real-world example of applying the 10-step process, highlighting challenges and successful strategies.
2. The Role of Technology in Accelerating Clinical Trial Start-Up: This explores the use of technology to improve efficiency in each of the 10 steps.
3. Optimizing Site Selection for Faster Clinical Trial Start-Up: A focused analysis on site selection, offering detailed strategies for efficient site identification and initiation.
4. Navigating Regulatory Hurdles in Clinical Trial Start-Up: A guide to navigating the complex regulatory landscape and ensuring compliance throughout the process.
5. Effective Budgeting and Resource Allocation in Clinical Trials: This article delves into best practices for developing a realistic budget and securing necessary resources.
6. Patient Recruitment Strategies: A Comprehensive Review: A deep dive into strategies for successful patient recruitment in clinical trials.
7. Best Practices in Clinical Trial Monitoring and Data Management: An overview of best practices for ensuring data quality and regulatory compliance.
8. The Importance of Investigator Training in Clinical Trials: This article underscores the importance of thorough training for all study personnel.
9. Contract Negotiation in Clinical Trials: Key Considerations: Focuses on the intricacies of contract negotiation with investigators and other stakeholders.
| 10 steps to clinical study start up: The Fundamentals of Clinical Research P. Michael Dubinsky, Karen A. Henry, 2022-01-26 This book focuses on the practical application of good clinical practice (GCP) fundamentals and provides insight into roles and responsibilities included in planning, executing, and analyzing clinical trials. The authors describe the design of quality into clinical trial planning and the application of regulatory, scientific, administrative, business, and ethical considerations. Describes the design of quality into the clinical trial planning Has end-of-chapter questions and answers to check learning and comprehension Includes charts that visually summarize the content and allow readers to cross-reference details in relevant chapters Offers a companion website containing supplemental training resources |
| 10 steps to clinical study start up: A Practical Guide to Managing Clinical Trials JoAnn Pfeiffer, Cris Wells, 2017-05-18 A Practical Guide to Managing Clinical Trials is a basic, comprehensive guide to conducting clinical trials. Designed for individuals working in research site operations, this user-friendly reference guides the reader through each step of the clinical trial process from site selection, to site set-up, subject recruitment, study visits, and to study close-out. Topics include staff roles/responsibilities/training, budget and contract review and management, subject study visits, data and document management, event reporting, research ethics, audits and inspections, consent processes, IRB, FDA regulations, and good clinical practices. Each chapter concludes with a review of key points and knowledge application. Unique to this book is A View from India, a chapter-by-chapter comparison of clinical trial practices in India versus the U.S. Throughout the book and in Chapter 10, readers will glimpse some of the challenges and opportunities in the emerging and growing market of Indian clinical trials. |
| 10 steps to clinical study start up: Sharing Clinical Trial Data Institute of Medicine, Board on Health Sciences Policy, Committee on Strategies for Responsible Sharing of Clinical Trial Data, 2015-04-20 Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research-from funders, to researchers, to journals, to physicians, and ultimately, to patients. |
| 10 steps to clinical study start up: The Four Villains of Clinical Trial Agreement Delays and How to Defeat Them Débora S. Araujo, 2018-04-09 Fictional superheroes are often charged with the task of saving the world from villains such as the Joker, Lex Luthor, Doctor Doom, and the Green Goblin. But superheroes cannot be effective if they only take out one of their villains and let the others roam free. In the same way, the pharmaceutical industry cannot effectively tackle the issue of delays in the execution of clinical trial agreements (CTAs) that leave patients lives hanging in the balance by only addressing one or two of the villains contributing to this broad challenge. Dbora Araujo relies on seasoned experience in the pharmaceutical industry that includes consulting for Fortune 500 companies and driving practical change regarding the business aspects of clinical trials to share a comprehensive exploration of the four villains who contribute to CTA negotiation delays and provide practical ways to address each of them. While encouraging positive change that patients desperately need, Araujo examines the negative impacts of ineffective site-budget negotiations, poor outsourced negotiations, a lack of industry adoption and innovation, and other issues affecting CTA negotiations. Included are several checklists, a common language evaluation and reconciliation initiative, and general CTA country requirements. In this comprehensive study, a pharmaceutical professional creatively examines how to address the four villains that cause frustrating delays in the execution of clinical trial agreements. |
| 10 steps to clinical study start up: Why Startups Fail Tom Eisenmann, 2021-03-30 If you want your startup to succeed, you need to understand why startups fail. “Whether you’re a first-time founder or looking to bring innovation into a corporate environment, Why Startups Fail is essential reading.”—Eric Ries, founder and CEO, LTSE, and New York Times bestselling author of The Lean Startup and The Startup Way Why do startups fail? That question caught Harvard Business School professor Tom Eisenmann by surprise when he realized he couldn’t answer it. So he launched a multiyear research project to find out. In Why Startups Fail, Eisenmann reveals his findings: six distinct patterns that account for the vast majority of startup failures. • Bad Bedfellows. Startup success is thought to rest largely on the founder’s talents and instincts. But the wrong team, investors, or partners can sink a venture just as quickly. • False Starts. In following the oft-cited advice to “fail fast” and to “launch before you’re ready,” founders risk wasting time and capital on the wrong solutions. • False Promises. Success with early adopters can be misleading and give founders unwarranted confidence to expand. • Speed Traps. Despite the pressure to “get big fast,” hypergrowth can spell disaster for even the most promising ventures. • Help Wanted. Rapidly scaling startups need lots of capital and talent, but they can make mistakes that leave them suddenly in short supply of both. • Cascading Miracles. Silicon Valley exhorts entrepreneurs to dream big. But the bigger the vision, the more things that can go wrong. Drawing on fascinating stories of ventures that failed to fulfill their early promise—from a home-furnishings retailer to a concierge dog-walking service, from a dating app to the inventor of a sophisticated social robot, from a fashion brand to a startup deploying a vast network of charging stations for electric vehicles—Eisenmann offers frameworks for detecting when a venture is vulnerable to these patterns, along with a wealth of strategies and tactics for avoiding them. A must-read for founders at any stage of their entrepreneurial journey, Why Startups Fail is not merely a guide to preventing failure but also a roadmap charting the path to startup success. |
| 10 steps to clinical study start up: The Comprehensive Guide To Clinical Research Chris Sauber, Dan Sfera, 2019-04-21 Condensing the most important topics in all of clinical research in an easy to understand presentation. The 20 percent of what you need to know in order to be 80 percent proficient!The authors who have operated various levels of businesses in the clinical research industry since 2005 believe that more practical information pertaining to clinical research needs to be accessible to individuals who are new to the industry or are curious about entering the rewarding world of clinical trials.This book reads in an easy to understand style and is based on proven methods the authors have developed to train their own employees and students of their various clinical research academies throughout the years. Picking this up and absorbing the information will allow anyone to gain much better insight into the complicated dynamics of clinical research. This practical roadmap is all you will need to get started on your clinical trial journey!In this book you will learn about:Regulations and the history as well as evolution of GCP.Clinical Research Site OperationsMonitoring Dynamics and Typical Monitoring VistsCRO ActivitiesSponsor Level DynamicsIndustry VendorsCommon Career Opportunities and Employment Roadmaps |
| 10 steps to clinical study start up: Small Clinical Trials Institute of Medicine, Board on Health Sciences Policy, Committee on Strategies for Small-Number-Participant Clinical Research Trials, 2001-01-01 Clinical trials are used to elucidate the most appropriate preventive, diagnostic, or treatment options for individuals with a given medical condition. Perhaps the most essential feature of a clinical trial is that it aims to use results based on a limited sample of research participants to see if the intervention is safe and effective or if it is comparable to a comparison treatment. Sample size is a crucial component of any clinical trial. A trial with a small number of research participants is more prone to variability and carries a considerable risk of failing to demonstrate the effectiveness of a given intervention when one really is present. This may occur in phase I (safety and pharmacologic profiles), II (pilot efficacy evaluation), and III (extensive assessment of safety and efficacy) trials. Although phase I and II studies may have smaller sample sizes, they usually have adequate statistical power, which is the committee's definition of a large trial. Sometimes a trial with eight participants may have adequate statistical power, statistical power being the probability of rejecting the null hypothesis when the hypothesis is false. Small Clinical Trials assesses the current methodologies and the appropriate situations for the conduct of clinical trials with small sample sizes. This report assesses the published literature on various strategies such as (1) meta-analysis to combine disparate information from several studies including Bayesian techniques as in the confidence profile method and (2) other alternatives such as assessing therapeutic results in a single treated population (e.g., astronauts) by sequentially measuring whether the intervention is falling above or below a preestablished probability outcome range and meeting predesigned specifications as opposed to incremental improvement. |
| 10 steps to clinical study start up: Envisioning a Transformed Clinical Trials Enterprise in the United States Institute of Medicine, Board on Health Sciences Policy, Forum on Drug Discovery, Development, and Translation, 2012-09-13 There is growing recognition that the United States' clinical trials enterprise (CTE) faces great challenges. There is a gap between what is desired - where medical care is provided solely based on high quality evidence - and the reality - where there is limited capacity to generate timely and practical evidence for drug development and to support medical treatment decisions. With the need for transforming the CTE in the U.S. becoming more pressing, the IOM Forum on Drug Discovery, Development, and Translation held a two-day workshop in November 2011, bringing together leaders in research and health care. The workshop focused on how to transform the CTE and discussed a vision to make the enterprise more efficient, effective, and fully integrated into the health care system. Key issue areas addressed at the workshop included: the development of a robust clinical trials workforce, the alignment of cultural and financial incentives for clinical trials, and the creation of a sustainable infrastructure to support a transformed CTE. This document summarizes the workshop. |
| 10 steps to clinical study start up: Clinical Trials in Neurology Bernard Ravina, Michael McDermott, 2012-04-12 Comprehensive book that suggests ways to improve the efficiency of clinical trials and the development of interventions in the neurosciences. |
| 10 steps to clinical study start up: Transforming Clinical Research in the United States Institute of Medicine, Board on Health Sciences Policy, Forum on Drug Discovery, Development, and Translation, 2010-10-22 An ideal health care system relies on efficiently generating timely, accurate evidence to deliver on its promise of diminishing the divide between clinical practice and research. There are growing indications, however, that the current health care system and the clinical research that guides medical decisions in the United States falls far short of this vision. The process of generating medical evidence through clinical trials in the United States is expensive and lengthy, includes a number of regulatory hurdles, and is based on a limited infrastructure. The link between clinical research and medical progress is also frequently misunderstood or unsupported by both patients and providers. The focus of clinical research changes as diseases emerge and new treatments create cures for old conditions. As diseases evolve, the ultimate goal remains to speed new and improved medical treatments to patients throughout the world. To keep pace with rapidly changing health care demands, clinical research resources need to be organized and on hand to address the numerous health care questions that continually emerge. Improving the overall capacity of the clinical research enterprise will depend on ensuring that there is an adequate infrastructure in place to support the investigators who conduct research, the patients with real diseases who volunteer to participate in experimental research, and the institutions that organize and carry out the trials. To address these issues and better understand the current state of clinical research in the United States, the Institute of Medicine's (IOM) Forum on Drug Discovery, Development, and Translation held a 2-day workshop entitled Transforming Clinical Research in the United States. The workshop, summarized in this volume, laid the foundation for a broader initiative of the Forum addressing different aspects of clinical research. Future Forum plans include further examining regulatory, administrative, and structural barriers to the effective conduct of clinical research; developing a vision for a stable, continuously funded clinical research infrastructure in the United States; and considering strategies and collaborative activities to facilitate more robust public engagement in the clinical research enterprise. |
| 10 steps to clinical study start up: Risk Management and Assessment Jorge Rocha, Sandra Oliveira, César Capinha, 2020-10-14 Risk analysis, risk evaluation and risk management are the three core areas in the process known as 'Risk Assessment'. Risk assessment corresponds to the joint effort of identifying and analysing potential future events, and evaluating the acceptability of risk based on the risk analysis, while considering influencing factors. In short, risk assessment analyses what can go wrong, how likely it is to happen and, if it happens, what are the potential consequences. Since risk is a multi-disciplinary domain, this book gathers contributions covering a wide spectrum of topics with regard to their theoretical background and field of application. The work is organized in the three core areas of risk assessment. |
| 10 steps to clinical study start up: Randomization in Clinical Trials William F. Rosenberger, John M. Lachin, 2015-11-23 Praise for the First Edition “All medical statisticians involved in clinical trials should read this book...” - Controlled Clinical Trials Featuring a unique combination of the applied aspects of randomization in clinical trials with a nonparametric approach to inference, Randomization in Clinical Trials: Theory and Practice, Second Edition is the go-to guide for biostatisticians and pharmaceutical industry statisticians. Randomization in Clinical Trials: Theory and Practice, Second Edition features: Discussions on current philosophies, controversies, and new developments in the increasingly important role of randomization techniques in clinical trials A new chapter on covariate-adaptive randomization, including minimization techniques and inference New developments in restricted randomization and an increased focus on computation of randomization tests as opposed to the asymptotic theory of randomization tests Plenty of problem sets, theoretical exercises, and short computer simulations using SAS® to facilitate classroom teaching, simplify the mathematics, and ease readers’ understanding Randomization in Clinical Trials: Theory and Practice, Second Edition is an excellent reference for researchers as well as applied statisticians and biostatisticians. The Second Edition is also an ideal textbook for upper-undergraduate and graduate-level courses in biostatistics and applied statistics. William F. Rosenberger, PhD, is University Professor and Chairman of the Department of Statistics at George Mason University. He is a Fellow of the American Statistical Association and the Institute of Mathematical Statistics, and author of over 80 refereed journal articles, as well as The Theory of Response-Adaptive Randomization in Clinical Trials, also published by Wiley. John M. Lachin, ScD, is Research Professor in the Department of Epidemiology and Biostatistics as well as in the Department of Statistics at The George Washington University. A Fellow of the American Statistical Association and the Society for Clinical Trials, Dr. Lachin is actively involved in coordinating center activities for clinical trials of diabetes. He is the author of Biostatistical Methods: The Assessment of Relative Risks, Second Edition, also published by Wiley. |
| 10 steps to clinical study start up: A Clinical Trials Manual From The Duke Clinical Research Institute Margaret Liu, Kate Davis, 2011-08-24 The publication of the second edition of this manual comes at an important juncture in the history of clinical research. As advances in information technology make it possible to link individuals and groups in diverse locations in jointly seeking the answers to pressing global health problems, it is critically important to remain vigilant about moral and ethical safeguards for every patient enrolled in a trial. Those who study this manual will be well aware of how to ensure patient safety along with fiscal responsibility, trial efficiency, and research integrity. —Robert Harrington, Professor of Medicine, Director, Duke Clinical Research Institute, Durham, North Carolina, USA The Duke Clinical Research Institute (DCRI) is one of the world's leading academic clinical research organizations; its mission is to develop and share knowledge that improves the care of patients around the world through innovative clinical research. This concise handbook provides a practical nuts and bolts approach to the process of conducting clinical trials, identifying methods and techniques that can be replicated at other institutions and medical practices. Designed for investigators, research coordinators, CRO personnel, students, and others who have a desire to learn about clinical trials, this manual begins with an overview of the historical framework of clinical research, and leads the reader through a discussion of safety concerns and resulting regulations. Topics include Good Clinical Practice, informed consent, management of subject safety and data, as well as monitoring and reporting adverse events. Updated to reflect recent regulatory and clinical developments, the manual reviews the conduct of clinical trials research in an increasingly global context. This new edition has been further expanded to include: In-depth information on conducting clinical trials of medical devices and biologics The role and responsibilities of Institutional Review Boards, and Recent developments regarding subject privacy concerns and regulations. Ethical documents such as the Belmont Report and the Declaration of Helsinki are reviewed in relation to all aspects of clinical research, with a discussion of how researchers should apply the principles outlined in these important documents. This graphically appealing and eminently readable manual also provides sample forms and worksheets to facilitate data management and regulatory record retention; these can be modified and adapted for use at investigative sites. |
| 10 steps to clinical study start up: Clinical Research in Asia U Sahoo, 2012-05-25 Asia is increasingly taking on a leading role in the fields of Good Clinical Practice (GCP) and ethics, two areas that are central to clinical research practices worldwide. Clinical research in Asia examines the evolution of these key sectors in the Asian countries where the greatest developments are taking place, offering valuable perspectives on a wide range of issues affecting clinical research. Following an introduction that provides an overview of the topic and its strengths and weaknesses, each chapter of the book is devoted to clinical research in a specific country, focusing on issues including the history and evolution of clinical research, clinical trials and regulatory aspects. The chapters also offer a perspective on future trends in clinical research in each country. The book concludes with a discussion of the importance of political, economic, socio-cultural, technological, legal and environmental factors (PESTLE analysis). - Analysis from a leading and highly respected professional in the sector - An overview of country-specific regulatory environments - Discussion of challenges and solutions for clinical research |
| 10 steps to clinical study start up: Reinventing Patient Recruitment Joan F. Bachenheimer, Bonnie A. Brescia, 2007 During the last five years, clinical research and development costs have risen exponentially without a proportionate increase in the number of new medications. While patient recruitment for clinical studies is only one component in the development of a new medicine or treatment, it is one of the most significant bottlenecks in the overall drug development process. Now it is imperative that industry leaders see beyond reactive measures and recognize that advancing their approach to patient recruitment is absolutely essential to advancing medicine and continuing the stability of their corporate brand across the globe. Reinventing Patient Recruitment: Revolutionary Ideas for Clinical Trial Success is a definitive guide to planning, implementing and evaluating recruitment strategies and campaigns globally. The combined experience of the authors provides a depth of perspective and boldness of innovative leadership to set the standards for future patient recruitment programs and practices. This book is a must-have for pharmaceutical, biotechnology and medical device industry professionals concerned with enrolling for domestic and multinational clinical studies and remaining on time and on budget. |
| 10 steps to clinical study start up: Principles of Good Clinical Practice Michael J. McGraw, 2010 Part of RPS Pharmacy Business Administration Series, this book offers good clinical practice guidelines. It includes standards on how clinical trials should be conducted, provide assurance of safety and efficacy of various drugs and protect human rights. |
| 10 steps to clinical study start up: How Not to Study a Disease Karl Herrup, 2023-03-07 An authority on Alzheimer's disease offers a history of past failures and a roadmap that points us in a new direction in our journey to a cure. For decades, some of our best and brightest medical scientists have dedicated themselves to finding a cure for Alzheimer's disease. What happened? Where is the cure? The biggest breakthroughs occurred twenty-five years ago, with little progress since. In How Not to Study a Disease, neurobiologist Karl Herrup explains why the Alzheimer's discoveries of the 1990s didn't bear fruit and maps a direction for future research. Herrup describes the research, explains what's taking so long, and offers an approach for resetting future research. Herrup offers a unique insider's perspective, describing the red flags that science ignored in the rush to find a cure. He is unsparing in calling out the stubbornness, greed, and bad advice that has hamstrung the field, but his final message is a largely optimistic one. Herrup presents a new and sweeping vision of the field that includes a redefinition of the disease and a fresh conceptualization of aging and dementia that asks us to imagine the brain as a series of interconnected neighborhoods. He calls for changes in virtually every aspect of the Alzheimer's disease research effort, from the drug development process, to the mechanisms of support for basic research, to the often-overlooked role of the scientific media, and more. With How Not to Study a Disease, Herrup provides a roadmap that points us in a new direction in our journey to a cure for Alzheimer's. |
| 10 steps to clinical study start up: A National Cancer Clinical Trials System for the 21st Century Institute of Medicine, Board on Health Care Services, Committee on Cancer Clinical Trials and the NCI Cooperative Group Program, 2010-07-08 The National Cancer Institute's (NCI) Clinical Trials Cooperative Group Program has played a key role in developing new and improved cancer therapies. However, the program is falling short of its potential, and the IOM recommends changes that aim to transform the Cooperative Group Program into a dynamic system that efficiently responds to emerging scientific knowledge; involves broad cooperation of stakeholders; and leverages evolving technologies to provide high-quality, practice-changing research. |
| 10 steps to clinical study start up: An Introduction to Clinical Trials Jonathan Cook, 2023-06-13 An Introduction to clinical trials is a concise step-by-step guide to the principles and practices of clinical trials for those studying clinical trials or new to working on one. Clinical trials are critical to the progress of medicine and improving healthcare, as they evaluate whether new treatments and interventions work. They are also complex, multidisciplinary projects that integrate science, ethics, and legal requirements in the conduct of medical research. Starting with the research question, An Introduction to clinical trials explains study design, sample size determination, study set-up, study conduct, statistical analysis, and dissemination of the results. The book primarily focusses on randomised controlled trials as the ultimate clinical trial. It demystifies the terminology used in clinical trials research and presents the underlying scientific and statistical concepts. Real-life examples are used throughout to bring concepts to life. Written by an experienced medical statistician, An Introduction to clinical trials will benefit readers of all backgrounds, from postgraduate and medical students, trainee doctors and healthcare professionals to others working on clinical trials in a professional capacity. This book aims to help readers gain a fuller and more rounded understanding of clinical trials. |
| 10 steps to clinical study start up: Broadly Engaged Team Science in Clinical and Translational Research Debra Lerner, Marisha E. Palm, Thomas W. Concannon, 2022-02-27 Despite the large U.S. investment in health science, and the vast and growing body of peer-reviewed research findings it has produced, a compelling body of evidence suggests that research too often has been slow, inefficient, and fallen short of desired impacts on health. A key question is how research might be changed to be more innovative, less wasteful, and more responsive to unmet health needs. One emerging response within clinical and translational science is to advance an approach that attempts to close the gap between research scientists and key stakeholders; the individuals and groups responsible for or affected by health-related decisions. Broadly engaged team science promises to support this aim by transforming the gold standard, multi-disciplinary team science, to include key stakeholders in activities across the research spectrum. These new roles and responsibilities range from generating research questions to implementing research projects, to aiding in the translation of discoveries from the laboratory to the community. A transition to broadly engaged team science reflects the idea that inclusivity and a diversity of perspectives are necessary to achieving progress in addressing complex health issues while representing a new benchmark for ethical research practice. This is one of the first collections of papers describing how clinical and translational science researchers are defining and implementing new research practices, and the successes and challenges involved. This book represents a first and critical step towards organizing knowledge of broadly engaged team science and advancing the development of evidence-based practices. Written in an accessible style, this book is intended to highlight the breadth of broadly engaged team science within one community, motivate researchers and stakeholders to build inclusive teams, bring rigor to often informal stakeholder engagement research practices and encourage people to think more broadly about the development of scientific knowledge. It includes examples of multi-disciplinary, broadly engaged team science projects, the perspectives of academic leaders about the changes needed to encourage scientists to conduct broadly engaged team science, and a resource directory. |
| 10 steps to clinical study start up: Field Trials of Health Interventions Peter G. Smith, Richard H. Morrow, David A. Ross, 2015 This is an open access title available under the terms of a CC BY-NC 4.0 International licence. It is free to read at Oxford Scholarship Online and offered as a free PDF download from OUP and selected open access locations. Before new interventions are released into disease control programmes, it is essential that they are carefully evaluated in field trials'. These may be complex and expensive undertakings, requiring the follow-up of hundreds, or thousands, of individuals, often for long periods. Descriptions of the detailed procedures and methods used in the trials that have been conducted have rarely been published. A consequence of this, individuals planning such trials have few guidelines available and little access to knowledge accumulated previously, other than their own. In this manual, practical issues in trial design and conduct are discussed fully and in sufficient detail, that Field Trials of Health Interventions may be used as a toolbox' by field investigators. It has been compiled by an international group of over 30 authors with direct experience in the design, conduct, and analysis of field trials in low and middle income countries and is based on their accumulated knowledge and experience. Available as an open access book via Oxford Medicine Online, this new edition is a comprehensive revision, incorporating the new developments that have taken place in recent years with respect to trials, including seven new chapters on subjects ranging from trial governance, and preliminary studies to pilot testing. |
| 10 steps to clinical study start up: Research Basics James V. Spickard, 2016-09-15 Research Basics: Design to Data Analysis in Six Steps offers a fresh and creative approach to the research process based on author James V. Spickard’s decades of teaching experience. Using an intuitive six-step model, readers learn how to craft a research question and then identify a logical process for answering it. Conversational writing and multi-disciplinary examples illuminate the model’s simplicity and power, effectively connecting the “hows” and “whys” behind social science research. Students using this book will learn how to turn their research questions into results. |
| 10 steps to clinical study start up: Rare Diseases and Orphan Products Institute of Medicine, Board on Health Sciences Policy, Committee on Accelerating Rare Diseases Research and Orphan Product Development, 2011-04-03 Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development. |
| 10 steps to clinical study start up: Principles and Practice of Clinical Research John I. Gallin, Frederick P Ognibene, 2011-04-28 The second edition of this innovative work again provides a unique perspective on the clinical discovery process by providing input from experts within the NIH on the principles and practice of clinical research. Molecular medicine, genomics, and proteomics have opened vast opportunities for translation of basic science observations to the bedside through clinical research. As an introductory reference it gives clinical investigators in all fields an awareness of the tools required to ensure research protocols are well designed and comply with the rigorous regulatory requirements necessary to maximize the safety of research subjects. Complete with sections on the history of clinical research and ethics, copious figures and charts, and sample documents it serves as an excellent companion text for any course on clinical research and as a must-have reference for seasoned researchers.*Incorporates new chapters on Managing Conflicts of Interest in Human Subjects Research, Clinical Research from the Patient's Perspective, The Clinical Researcher and the Media, Data Management in Clinical Research, Evaluation of a Protocol Budget, Clinical Research from the Industry Perspective, and Genetics in Clinical Research *Addresses the vast opportunities for translation of basic science observations to the bedside through clinical research*Delves into data management and addresses how to collect data and use it for discovery*Contains valuable, up-to-date information on how to obtain funding from the federal government |
| 10 steps to clinical study start up: Examining the Impact of Real-World Evidence on Medical Product Development National Academies of Sciences, Engineering, and Medicine, Health and Medicine Division, Board on Health Sciences Policy, Forum on Drug Discovery, Development, and Translation, 2019-04-05 Randomized controlled trials (RCTs) have traditionally served as the gold standard for generating evidence about medical interventions. However, RCTs have inherent limitations and may not reflect the use of medical products in the real world. Additionally, RCTs are expensive, time consuming, and cannot answer all questions about a product or intervention. Evidence generated from real-world use, such as real-world evidence (RWE) may provide valuable information, alongside RCTs, to inform medical product decision making. To explore the potential for using RWE in medical product decision making, the National Academies of Sciences, Engineering, and Medicine planned a three-part workshop series. The series was designed to examine the current system of evidence generation and its limitations, to identify when and why RWE may be an appropriate type of evidence on which to base decisions, to learn from successful initiatives that have incorporated RWE, and to describe barriers that prevent RWE from being used to its full potential. This publication summarizes the discussions from the entire workshop series. |
| 10 steps to clinical study start up: Start-Up Inge Hill, 2015-10-11 Start-Up is ideal for anyone looking to start a business – whether you are a student or a professional preparing to launch your own business or social enterprise. It covers the crucial business processes you need to consider when starting a new venture, and contains inspirational and educational cases of successful start-ups by young people from across the globe, including the UK, the US, Hong Kong and Romania. Drawing on the author's extensive practical experience, this book is a unique and invaluable guide to the world of start-ups. Key features: - Assumes no prior knowledge and covers essential finance skills. - Firmly based in practice with detailed advice on carrying out market and industry research. - Features an extensive range of international case studies and examples of start-ups. This concise and lively book is the perfect resource for students and entrepreneurs alike. |
| 10 steps to clinical study start up: National Statement on Ethical Conduct in Human Research 2023 National Health and Medical Research Council (Australia), Australian Research Council, Universities Australia, 2023 The purpose of the National Statement is to promote ethically good human research. Fulfilment of this purpose requires that participants be accorded the respect and protection that is due to them. It also involves the fostering of research that is of benefit to the community. The National Statement is therefore designed to clarify the responsibilities of: institutions and researchers for the ethical design, conduct and dissemination of results of human research ; and review bodies in the ethics review of research. The National Statement will help them to meet their responsibilities: to identify issues of ethics that arise in the design, review and conduct of human research, to deliberate about those ethical issues, and to justify decisions about them--Page 6. |
| 10 steps to clinical study start up: Registries for Evaluating Patient Outcomes Agency for Healthcare Research and Quality/AHRQ, 2014-04-01 This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews. |
| 10 steps to clinical study start up: Textbook of Clinical Trials David Machin, Simon Day, Sylvan Green, 2007-01-11 Now published in its Second Edition, the Textbook of Clinical Trials offers detailed coverage of trial methodology in diverse areas of medicine in a single comprehensive volume. Praise for the First Edition: ... very useful as an introduction to clinical research, or for those planning specific studies within therapeutic or disease areas. BRITISH JOURNAL OF SURGERY, Vol. 92, No. 2, February 2005 The book’s main concept is to describe the impact of clinical trials on the practice of medicine. It separates the information by therapeutic area because the impact of clinical trials, the problems encountered, and the numbers of trials in existence vary tremendously from specialty to specialty. The sections provide a background to the disease area and general clinical trial methodology before concentrating on particular problems experienced in that area. Specific examples are used throughout to address these issues. The Textbook of Clinical Trials, Second Edition: Highlights the various ways clinical trials have influenced the practice of medicine in many therapeutic areas Describes the challenges posed by those conducting clinical trials over a range of medical specialities and allied fields Additional therapeutic areas are included in this Second Edition to fill gaps in the First Edition as the number and complexity of trials increases in this rapidly developing area Newly covered or updated in the Second Edition: general surgery, plastic surgery, aesthetic surgery, palliative care, primary care, anaesthesia and pain, transfusion, wound healing, maternal and perinatal health, early termination, organ transplants, ophthalmology, epilepsy, infectious disease, neuro-oncology, adrenal, thyroid and urological cancers, as well as a chapter on the Cochrane network An invaluable resource for pharmaceutical companies, the Textbook of Clinical Trials, Second Edition appeals to those working in contract research organizations, medical departments and in the area of public health and health science alike. |
| 10 steps to clinical study start up: Usability Evaluation In Industry Patrick W. Jordan, B. Thomas, Ian Lyall McClelland, Bernard Weerdmeester, 1996-06-11 This book provides a variety of answers in its description and discussion of new, sometimes radical approaches to `usability evaluation', now an increasingly common business tool. It contains new thinking of the subject of usability evaluation in industry. Contributions come from those involved in the practice of industry-based usability evaluation |
| 10 steps to clinical study start up: Clinical Trials Duolao Wang, Ameet Bakhai, 2006 This book explains statistics specifically for a medically literate audience. Readers gain not only an understanding of the basics of medical statistics, but also a critical insight into how to review and evaluate clinical trial evidence. |
| 10 steps to clinical study start up: Understanding Clinical Research Renato D. Lopes, Robert A. Harrington, 2013-05-22 A complete guide to understanding and applying clinical research results Ideal for both researchers and healthcare providers Understanding Clinical Research addresses both the operational challenges of clinical trials and the needs of clinicians to comprehend the nuances of research methods to accurately analyze study results. This timely resource covers all aspects of clinical trials--from study design and statistics to regulatory oversight--and it delivers a detailed yet streamlined overview of must-know research topics. The text features an accessible three-part organization that traces the evolution of clinical research and explains the bedrock principles and unique challenges of clinical experimentation and observational research. Reinforcing this content are real-life case examples--drawn from the authors' broad experience--that put chapter concepts into action and contribute to a working knowledge of integral research techniques. FEATURES: The most definitive guide to promoting excellence in clinical research, designed to empower healthcare providers to assess a study's strengths and weaknesses with confidence and apply this knowledge to optimize patient outcomes In-depth coverage of fundamental research methods and protocols from preeminent authorities provides readers with an instructive primer and a springboard for ongoing clinical research education Clear, comprehensive three-part organization: Section One: Evolution of Clinical Research offers a succinct history of clinical trials, drug regulations, and the role of the FDA while covering the impact of information technology and academic research organizations Section Two: Principles of Clinical Experimentation takes you through the typical phases of clinical trials in the development of medical products, from initial human subject research to postapproval surveillance studies Section Three: Observational Research highlights the underlying principles, pitfalls, and methods for case-control studies, cohort studies, registries, and subgroup analyses within randomized trials |
| 10 steps to clinical study start up: Improving and Accelerating Therapeutic Development for Nervous System Disorders Institute of Medicine, Board on Health Sciences Policy, Forum on Neuroscience and Nervous System Disorders, 2014-02-06 Improving and Accelerating Therapeutic Development for Nervous System Disorders is the summary of a workshop convened by the IOM Forum on Neuroscience and Nervous System Disorders to examine opportunities to accelerate early phases of drug development for nervous system drug discovery. Workshop participants discussed challenges in neuroscience research for enabling faster entry of potential treatments into first-in-human trials, explored how new and emerging tools and technologies may improve the efficiency of research, and considered mechanisms to facilitate a more effective and efficient development pipeline. There are several challenges to the current drug development pipeline for nervous system disorders. The fundamental etiology and pathophysiology of many nervous system disorders are unknown and the brain is inaccessible to study, making it difficult to develop accurate models. Patient heterogeneity is high, disease pathology can occur years to decades before becoming clinically apparent, and diagnostic and treatment biomarkers are lacking. In addition, the lack of validated targets, limitations related to the predictive validity of animal models - the extent to which the model predicts clinical efficacy - and regulatory barriers can also impede translation and drug development for nervous system disorders. Improving and Accelerating Therapeutic Development for Nervous System Disorders identifies avenues for moving directly from cellular models to human trials, minimizing the need for animal models to test efficacy, and discusses the potential benefits and risks of such an approach. This report is a timely discussion of opportunities to improve early drug development with a focus toward preclinical trials. |
| 10 steps to clinical study start up: Drug Repurposing Farid A. Badria, 2020-12-02 Drug repurposing or drug repositioning is a new approach to presenting new indications for common commercial and clinically approved existing drugs. For example, chloroquine, an old antimalarial drug, showed promising results for treating COVID-19, interfering with MDR in several types of cancer, and chemosensitizing human leukemic cells.This book focuses on the hypothesis, risk/benefits, and economic impacts of drug repurposing on drug discovery in dermatology, infectious diseases, neurological disorders, cancer, and orphan diseases. It brings together up-to-date research to provide readers with an informative, illustrative, and easy-to-read book useful for students, clinicians, and the pharmaceutical industry. |
| 10 steps to clinical study start up: Study Guide and Procedure Checklist Manual for Kinn's The Clinical Medical Assistant - E-Book Deborah B. Proctor, Brigitte Niedzwiecki, Julie Pepper, Martha (Marti) Garrels, Helen Mills, 2016-06-07 Get more practice with the essential medical assisting job skills! Designed to support Kinn’s The Clinical Medical Assistant: An Applied Learning Approach, 13th Edition, Kinn's The Clinical Medical Assistant – Study Guide and Procedure Checklist Manual Package: An Applied Learning Approach, 13th Edition offers a wide range of exercises to reinforce your understanding of common clinical skills — including CAAHEP and ABHES competencies. A variety of exercises test your knowledge and critical thinking skills with vocabulary review, multiple choice, fill in the blank, and true/false questions. Additional exercises enhance learning with skills and concepts, word puzzles, case studies, workplace applications, and Internet activities. Procedure checklists help you track your performance of every procedure included in the textbook. Work products allow you to provide documentation to instructors and to accrediting organizations when a competency has been mastered. Cross-references tie together exercises in the study guide to the Connections theme in the main text. NEW! Eight procedure checklists based on CAAHEP competencies provide an assessment tool for MA procedures. NEW! Glucometer test results and Mantoux test records allow you to assess how well you’re able to perform these procedures. NEW! SimChart for the Medical Office Connection ties EHR cases to appropriate chapters. |
| 10 steps to clinical study start up: 10 Steps to Take Charge of Your Emotional Life Eve Wood, M.D., 2008-01-01 From the best-selling author of There's Always Help, There's Always Hope. Psychiatrist, professor, and award-winning author Eve Wood trusts in your capacity to heal—to clear the way to a natural state of hope, harmony, and well-being. The insights and tools she shares in this book will enable you to identify and resolve your issues. Dr. Christiane Northrup says this book is one of the best books I’ve ever seen on how to achieve emotional balance and happiness. It’s practical, real world and very readable. Dr. Wood is my kind of doctor. Dr. Wood makes healing a simple process that anyone can understand. She walks you through ten steps that encompass examples, stories, exercises, and guidance. You’ll take stock of where you are and discover what you can do to transform your life. You’ll learn to address your negative thoughts and beliefs, make life choices that fit your nature, and develop strategies to support your innate capacity to heal. Whether you suspect that you’re suffering from a known condition or you simply want to understand yourself better, this insightful book is a path, a promise, and a prayer for that truly transformative way of healing to begin. |
| 10 steps to clinical study start up: Good Research Practice in Non-Clinical Pharmacology and Biomedicine Anton Bespalov, Martin C. Michel, Thomas Steckler, 2020-01-01 This open access book, published under a CC BY 4.0 license in the Pubmed indexed book series Handbook of Experimental Pharmacology, provides up-to-date information on best practice to improve experimental design and quality of research in non-clinical pharmacology and biomedicine. |
| 10 steps to clinical study start up: Oncology Clinical Trials Susan Halabi, PhD, William Kevin Kelly, DO, 2009-12-22 Clinical trials are the engine of progress in the development of new drugs and devices for the detection, monitoring, prevention and treatment of cancer. A well conceived, carefully designed and efficiently conducted clinical trial can produce results that change clinical practice overnight, deliver new oncology drugs and diagnostics to the marketplace, and expand the horizon of contemporary thinking about cancer biology. A poorly done trial does little to advance the field or guide clinical practice, consumes precious clinical and financial resources and challenges the validity of the ethical contract between investigators and the volunteers who willingly give their time and effort to benefit future patients. With chapters written by oncologists, researchers, biostatisticians, clinical research administrators, and industry and FDA representatives, Oncology Clinical Trials, provides a comprehensive guide for both early-career and senior oncology investigators into the successful design, conduct and analysis of an oncology clinical trial. Oncology Clinical Trials covers how to formulate a study question, selecting a study population, study design of Phase I, II, and III trials, toxicity monitoring, data analysis and reporting, use of genomics, cost-effectiveness analysis, systemic review and meta-analysis, and many other issues. Many examples of real-life flaws in clinical trials that have been reported in the literature are included throughout. The book discusses clinical trials from start to finish focusing on real-life examples in the development, design and analysis of clinical trials. Oncology Clinical Trials features: A systematic guide to all aspects of the design, conduct, analysis, and reporting of clinical trials in oncology Contributions from oncologists, researchers, biostatisticians, clinical research administrators, and industry and FDA representatives Hot topics in oncology trials including multi-arm trials, meta-analysis and adaptive design, use of genomics, and cost-effectiveness analysis Real-life examples from reported clinical trials included throughout |
| 10 steps to clinical study start up: Modern Methods of Clinical Investigation Institute of Medicine, Committee on Technological Innovation in Medicine, 1990-02-01 The very rapid pace of advances in biomedical research promises us a wide range of new drugs, medical devices, and clinical procedures. The extent to which these discoveries will benefit the public, however, depends in large part on the methods we choose for developing and testing them. Modern Methods of Clinical Investigation focuses on strategies for clinical evaluation and their role in uncovering the actual benefits and risks of medical innovation. Essays explore differences in our current systems for evaluating drugs, medical devices, and clinical procedures; health insurance databases as a tool for assessing treatment outcomes; the role of the medical profession, the Food and Drug Administration, and industry in stimulating the use of evaluative methods; and more. This book will be of special interest to policymakers, regulators, executives in the medical industry, clinical researchers, and physicians. |
| 10 steps to clinical study start up: Ethical Conduct of Clinical Research Involving Children Institute of Medicine, Board on Health Sciences Policy, Committee on Clinical Research Involving Children, 2004-07-09 In recent decades, advances in biomedical research have helped save or lengthen the lives of children around the world. With improved therapies, child and adolescent mortality rates have decreased significantly in the last half century. Despite these advances, pediatricians and others argue that children have not shared equally with adults in biomedical advances. Even though we want children to benefit from the dramatic and accelerating rate of progress in medical care that has been fueled by scientific research, we do not want to place children at risk of being harmed by participating in clinical studies. Ethical Conduct of Clinical Research Involving Children considers the necessities and challenges of this type of research and reviews the ethical and legal standards for conducting it. It also considers problems with the interpretation and application of these standards and conduct, concluding that while children should not be excluded from potentially beneficial clinical studies, some research that is ethically permissible for adults is not acceptable for children, who usually do not have the legal capacity or maturity to make informed decisions about research participation. The book looks at the need for appropriate pediatric expertise at all stages of the design, review, and conduct of a research project to effectively implement policies to protect children. It argues persuasively that a robust system for protecting human research participants in general is a necessary foundation for protecting child research participants in particular. |
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STUDY START UP - ONBOARDING GUIDE - BRANY
New clinical research coordinators must navigate complex issues and procedures for starting clinical trials. This quick guide provides a few tips and critical questions you should ask at the …
Study Start Up & The Village It Takes [a multi-faceted …
The purpose of this presentation is to present a general overview to study start up and the multiple layers that come with it. This presentation will dive into different perspectives while diving into a …
OHSU Study Start-up Process
Sep 24, 2021 · • Cover the study start-up process for a typical OHSU human subjects research project • Direct study teams to policies, tools, and resources • Discuss dependencies between …
URMC Clinical Research Study Start-Up Manual - University …
The purpose of this guide is to review best practices concerning Study Start-Up within the University of Rochester (UR). This guide is not Department nor Sponsor specific and is an overall …
10 Steps To Clinical Study Start Up (2024) - x-plane.com
The quintessential "10 steps to clinical study start-up" typically encompasses stages from protocol development and IRB submission to site selection, investigator training, and patient recruitment. …
Accelerating Study Activation: Breaking Down Silos for Start …
Identify which steps require input, review, or approval. Determine the essential requirements for approval to move forward. Define the role or individual responsible for each approval. Outcome: …
Study Start-Up Timelines: Identifying Challenges
With medical product development continuing to last up to 10 years and costing hundreds of millions of dollars, the lengthiness of the study start-up (SSU) process has become a key issue …
Study Start Up for MCRI-Sponsored Clinical Trial
guidance for navigating the clinical trial study start-up process and procedures. The study start-up process begins with the development of a clinical study plan in the form of a protocol.
The Study Start-Up Process - ITHS
• Understand infrastructure maturity requirements for clinical research • Understand the general pathway for study start-up • Know how to conduct an after-action review
Handout: Study Startup Process Steps for Industry Funded …
Start (DOCR) Maestro . Clinical Build. Validation (Study Team) Maestro . Clinical Build. Complete (DOCR) Maestro . Billing Build (DOCR & PRMO) Agreement . Intake (ORC) Legal Terms . Approval …
Clinical Trials Start Up
To describe the clinical trials start up for South Western Sydney Local Health District (SWSLHD) and Ingham Institute under the instruction of the named Principal Investigator (PI) during the …
Study Startup and Initiation – The Agony and the Ecstasy
plan this out for your specific study and specific needs. What can you do right away so you can move on to other steps? What will take a long time so it needs done right away? What are the …
Clinical Research Contracting - Johns Hopkins University
Mar 31, 2015 · What is Clinical Research? planning of clinical/lab services in support of clinical research. Includes “compassionate use” or “expanded access” studies. What do I submit?: …
Site Initiation/Study Start-Up Visit Tip Sheet - University …
A Site Initiation Visit (SIV) or Study Start-Up is an organized meeting to discuss the new protocol before the research project is ready to screen and enroll potential patients. It also serves as …
10 Steps To Clinical Study Start Up (PDF) - x-plane.com
10 Steps To Clinical Study Start Up: Sharing Clinical Trial Data Institute of Medicine,Board on Health Sciences Policy,Committee on Strategies for Responsible Sharing of Clinical Trial Data,2015-04 …
Checklist for Clinical Investigators: Investigator-Initiated …
The following checklist outlines the steps needed to initiate and conduct an investigator-initiated clinical study as you work with the Clinical Research Division (CRD). Checklist for Investigators 1. …
White Paper Study Start-Up Challenges: Hard Realities, - IQVIA
Faster Study Start-ups: Making Progress in the Face of Industry Headwinds. These industry leaders shared pragmatic, actionable steps that pharmaceutical and biotech companies of all sizes can …
Collaborating to Improve Clinical Trial Activation Timelines
To improve cancer clinical trial operations, the AACI Corporate Roundtable Trial Activation Task Force convened to critically examine the trial activation process and develop best practices to …
