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| financial disclosure form clinical trials: 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. |
| financial disclosure form clinical trials: Responsible Research Institute of Medicine, Committee on Assessing the System for Protecting Human Research Participants, 2003-02-06 When 18-year-old Jesse Gelsinger died in a gene transfer study at the University of Pennsylvania, the national spotlight focused on the procedures used to ensure research participants' safety and their capacity to safeguard the well-being of those who volunteer for research studies. Responsible Research outlines a three-pronged approach to ensure the protection of every participant through the establishment of effective Human Research Participant Protection Programs (HRPPPs). The approach includes: Improved research review processes, Recognition and integration of research participants' contributions to the system, and Vigilant maintenance of HRPPP performance. Issues addressed in the book include the need for in-depth, complimentary reviews of science, ethics, and conflict of interest reviews; desired qualifications for investigators and reviewers; the process of informed consent; federal and institutional oversight; and the role of accreditation. Recommendations for areas of key interest include suggestions for legislative approaches, compensation for research-related injury, and the refocusing of the mission of institutional review boards. Responsible Research will be important to anyone interested in the issues that are relevant to the practice of using human subjects as research participants, but especially so to policy makers, research administrators, investigators, and research sponsorsâ€but also including volunteers who may agree to serve as research participants. |
| financial disclosure form clinical trials: 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. |
| financial disclosure form clinical trials: Conflict of Interest in Medical Research, Education, and Practice Institute of Medicine, Board on Health Sciences Policy, Committee on Conflict of Interest in Medical Research, Education, and Practice, 2009-09-16 Collaborations of physicians and researchers with industry can provide valuable benefits to society, particularly in the translation of basic scientific discoveries to new therapies and products. Recent reports and news stories have, however, documented disturbing examples of relationships and practices that put at risk the integrity of medical research, the objectivity of professional education, the quality of patient care, the soundness of clinical practice guidelines, and the public's trust in medicine. Conflict of Interest in Medical Research, Education, and Practice provides a comprehensive look at conflict of interest in medicine. It offers principles to inform the design of policies to identify, limit, and manage conflicts of interest without damaging constructive collaboration with industry. It calls for both short-term actions and long-term commitments by institutions and individuals, including leaders of academic medical centers, professional societies, patient advocacy groups, government agencies, and drug, device, and pharmaceutical companies. Failure of the medical community to take convincing action on conflicts of interest invites additional legislative or regulatory measures that may be overly broad or unduly burdensome. Conflict of Interest in Medical Research, Education, and Practice makes several recommendations for strengthening conflict of interest policies and curbing relationships that create risks with little benefit. The book will serve as an invaluable resource for individuals and organizations committed to high ethical standards in all realms of medicine. |
| financial disclosure form clinical trials: 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. |
| financial disclosure form clinical trials: Dietary Supplements United States. Federal Trade Commission. Bureau of Consumer Protection, 1998 |
| financial disclosure form clinical trials: Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making Institute of Medicine, Roundtable on Research and Development of Drugs, Biologics, and Medical Devices, 1999-07-27 In an effort to increase knowledge and understanding of the process of assuring data quality and validity in clinical trials, the IOM hosted a workshop to open a dialogue on the process to identify and discuss issues of mutual concern among industry, regulators, payers, and consumers. The presenters and panelists together developed strategies that could be used to address the issues that were identified. This IOM report of the workshop summarizes the present status and highlights possible strategies for making improvements to the education of interested and affected parties as well as facilitating future planning. |
| financial disclosure form clinical trials: 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. |
| financial disclosure form clinical trials: American Society of Hematology Self-Assessment Program Timothy Graubert, James R. Cook, Laura Scheuttpelz, Donald M. Arnold, Adam Cuker, Cindy Neunert, Keith R. McCrae, Margaret Ragni, Sarah O'Brien, Murat Arcasoy, Gary Lyman, Marc J. Kahn, Lawrence A. Solberg, Jecko Thachil, Timothy James Littlewood, Sioban Keel, Charles T. Quinn, Charles H. Packman, Stephan Moll, David Garcia, David P. Steensma, Anjali Sharathkumar, Jorge Di Paola, Amy D. Shapiro, A. Koneti Rao, Charles Eby, Jacob Rand, John Frater, Karen Quillen, Suzanne Bakdash, Dan S. Kaufman, David T. Scadden, Jerald Radich, Sergio Giralt, Geoffrey L. Uy, Inderjeet Dokal, Ross Levine, Ramon V. Tiu, Phillip Scheinberg, Lillian Sung, B. Douglas Smith, Daniel J. DeAngelo, Ching-Hon Pui, Kristie A. Blum, Ann LaCasce, Kerry Joanne Savage, Brad S. Kahl, Grzegorz S. Nowakowski, Vicki A. Morrison, Irene Ghobrial, Martha Lacy, 2013-06-04 Hematologists and others working in hematology-related fields need to stay current with the latest advances in the rapidly evolving disciplines of adult and pediatric hematology. The American Society of Hematology Self-Assessment Program (ASH-SAP) is the only complete, comprehensive, educational resource available that fulfills this need, while also providing thorough board and recertification preparation, as well as AMA PRA Category 1 Credit'. |
| financial disclosure form clinical trials: Model Rules of Professional Conduct American Bar Association. House of Delegates, Center for Professional Responsibility (American Bar Association), 2007 The Model Rules of Professional Conduct provides an up-to-date resource for information on legal ethics. Federal, state and local courts in all jurisdictions look to the Rules for guidance in solving lawyer malpractice cases, disciplinary actions, disqualification issues, sanctions questions and much more. In this volume, black-letter Rules of Professional Conduct are followed by numbered Comments that explain each Rule's purpose and provide suggestions for its practical application. The Rules will help you identify proper conduct in a variety of given situations, review those instances where discretionary action is possible, and define the nature of the relationship between you and your clients, colleagues and the courts. |
| financial disclosure form clinical trials: 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. |
| financial disclosure form clinical trials: 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. |
| financial disclosure form clinical trials: 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. |
| financial disclosure form clinical trials: 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. |
| financial disclosure form clinical trials: Reviewing Clinical Trials Chinese University of Hong Kong, Chinese University of Hong Kong. Clinical Trials Centre, Washington, DC. Association for the Accreditation of Human research Protection Programs, Inc, 2010 The idea for this manual came from Pfizer in the US, which provided the Clinical Trials Centre at The University of Hong Kong, Hong Kong SAR, PR China with a nonbinding grant for its development. The general project layout protocol was accepted by Pfizer in July 2009. Pfizer has not in any way interfered with the project, except for providing nonbinding comments to the final product. The entire text of this manual was written by Johan PE Karlberg. Marjorie A Speers provided considerable and essential comments on the contents and the first and subsequent drafts. A group of international human research protection experts mostly working in non-profit institutions or organisations - see Contributors for details - reviewed and provided important comments on the contents and final draft. It was solely created with the intention to promote human research protection of participants in clinical trials. This manual will be translated into numerous languages and is provided free of charge as an electronic file over the Internet (http://www.ClinicalTrialMagnifier.com) and offered in print for a fee. The objective beyond this project is to establish educational activities, developed around the manual, and jointly organised with leading academic institutions worldwide. |
| financial disclosure form clinical trials: 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 |
| financial disclosure form clinical trials: Beyond the HIPAA Privacy Rule Institute of Medicine, Board on Health Care Services, Board on Health Sciences Policy, Committee on Health Research and the Privacy of Health Information: The HIPAA Privacy Rule, 2009-03-24 In the realm of health care, privacy protections are needed to preserve patients' dignity and prevent possible harms. Ten years ago, to address these concerns as well as set guidelines for ethical health research, Congress called for a set of federal standards now known as the HIPAA Privacy Rule. In its 2009 report, Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research, the Institute of Medicine's Committee on Health Research and the Privacy of Health Information concludes that the HIPAA Privacy Rule does not protect privacy as well as it should, and that it impedes important health research. |
| financial disclosure form clinical trials: Clinical Trials in Neurology Bernard Ravina, Jeffrey Cummings, Michael McDermott, R. Michael Poole, 2012-04-12 Translating laboratory discoveries into successful therapeutics can be difficult. Clinical Trials in Neurology aims to improve the efficiency of clinical trials and the development of interventions in order to enhance the development of new treatments for neurologic diseases. It introduces the reader to the key concepts underpinning trials in the neurosciences. This volume tackles the challenges of developing therapies for neurologic disorders from measurement of agents in the nervous system to the progression of clinical signs and symptoms through illustrating specific study designs and their applications to different therapeutic areas. Clinical Trials in Neurology covers key issues in Phase I, II and III clinical trials, as well as post-marketing safety surveillance. Topics addressed include regulatory and implementation issues, outcome measures and common problems in drug development. Written by a multidisciplinary team, this comprehensive guide is essential reading for neurologists, psychiatrists, neurosurgeons, neuroscientists, statisticians and clinical researchers in the pharmaceutical industry. |
| financial disclosure form clinical trials: 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. |
| financial disclosure form clinical trials: ClinicalTrials Curtis L. Meinert, 2012-03-27 The classic, definitive guide to the design, conduct, and analysis of randomized clinical trials. |
| financial disclosure form clinical trials: Women and Health Research Institute of Medicine, Committee on Ethical and Legal Issues Relating to the Inclusion of Women in Clinical Studies, 1994-02-01 In the nineteenth century some scientists argued that women should not be educated because thinking would use energy needed by the uterus for reproduction. The proof? Educated women had a lower birth rate. Today's researchers can only shake their heads at such reasoning. Yet professional journals and the popular press are increasingly criticizing medical research for ignoring women's health issues. Women and Health Research examines the facts behind the public's perceptions about women participating as subjects in medical research. With the goal of increasing researchers' awareness of this important topic, the book explores issues related to maintaining justice (in its ethical sense) in clinical studies. Leading experts present general principles for the ethical conduct of research on womenâ€principles that are especially important in the light of recent changes in federal policy on the inclusion of women in clinical research. Women and Health Research documents the historical shift from a paternalistic approach by researchers toward women and a disproportionate reliance on certain groups for research to one that emphasizes proper access for women as subjects in clinical studies in order to ensure that women receive the benefits of research. The book addresses present-day challenges to equity in four areas: Scientificâ€Do practical aspects of scientific research work at cross-purposes to gender equity? Focusing on drug trials, the authors identify rationales for excluding people from research based on demographics. Social and Ethicalâ€The authors offer compelling discussions on subjectivity in science, the evidence for male bias, and issues related to race and ethnicity, as well as the recruitment, retention, and protection of research participants. Legalâ€Women and Health Research reviews federal research policies that affect the inclusion of women and evaluates the basis for researchers' fears about liability, citing court cases. Riskâ€The authors focus on risks to reproduction and offspring in clinical drug trials, exploring how risks can be identified for study participants, who should make the assessment of risk and benefit for participation in a clinical study, and how legal implications could be addressed. This landmark study will be of immediate use to the research community, policymakers, women's health advocates, attorneys, and individuals. |
| financial disclosure form clinical trials: Crossing the Quality Chasm Institute of Medicine, Committee on Quality of Health Care in America, 2001-07-19 Second in a series of publications from the Institute of Medicine's Quality of Health Care in America project Today's health care providers have more research findings and more technology available to them than ever before. Yet recent reports have raised serious doubts about the quality of health care in America. Crossing the Quality Chasm makes an urgent call for fundamental change to close the quality gap. This book recommends a sweeping redesign of the American health care system and provides overarching principles for specific direction for policymakers, health care leaders, clinicians, regulators, purchasers, and others. In this comprehensive volume the committee offers: A set of performance expectations for the 21st century health care system. A set of 10 new rules to guide patient-clinician relationships. A suggested organizing framework to better align the incentives inherent in payment and accountability with improvements in quality. Key steps to promote evidence-based practice and strengthen clinical information systems. Analyzing health care organizations as complex systems, Crossing the Quality Chasm also documents the causes of the quality gap, identifies current practices that impede quality care, and explores how systems approaches can be used to implement change. |
| financial disclosure form clinical trials: The Complete Book of Medical Device Clinical Trials in the United States , |
| financial disclosure form clinical trials: Minority Access to Research Careers Program , 1993 |
| financial disclosure form clinical trials: 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. |
| financial disclosure form clinical trials: Fundamentals of Clinical Trials Lawrence M. Friedman, Curt Furberg, David L. DeMets, 1998 This classic reference, now updated with the newest applications and results, addresses the fundamentals of such trials based on sound scientific methodology, statistical principles, and years of accumulated experience by the three authors. |
| financial disclosure form clinical trials: Clinical Trials Handbook Shayne Cox Gad, 2009-06-17 Best practices for conducting effective and safe clinical trials Clinical trials are arguably the most important steps in proving drug effectiveness and safety for public use. They require intensive planning and organization and involve a wide range of disciplines: data management, biostatistics, pharmacology, toxicology, modeling and simulation, regulatory monitoring, ethics, and particular issues for given disease areas. Clinical Trials Handbook provides a comprehensive and thorough reference on the basics and practices of clinical trials. With contributions from a range of international authors, the book takes the reader through each trial phase, technique, and issue. Chapters cover every key aspect of preparing and conducting clinical trials, including: Interdisciplinary topics that have to be coordinated for a successful clinical trialData management (and adverse event reporting systems) Biostatistics, pharmacology, and toxicology Modeling and simulation Regulatory monitoring and ethics Particular issues for given disease areas-cardiology, oncology, cognitive, dementia, dermatology, neuroscience, and more With unique information on such current issues as adverse event reporting (AER) systems, adaptive trial designs, and crossover trial designs, Clinical Trials Handbook will be a ready reference for pharmaceutical scientists, statisticians, researchers, and the many other professionals involved in drug development. |
| financial disclosure form clinical trials: International Ethical Guidelines for Health-Related Research Involving Humans Council for International Organizations of Medical Sciences (CIOMS), 2017-01-31 In the new 2016 version of the ethical guidelines, CIOMS provides answers to a number of pressing issues in research ethics. The Council does so by stressing the need for research having scientific and social value, by providing special guidelines for health-related research in low-resource settings, by detailing the provisions for involving vulnerable groups in research and for describing under what conditions biological samples and health-related data can be used for research.--Page 4 de la couverture. |
| financial disclosure form clinical trials: Global Clinical Trials Playbook Menghis Bairu, Richard Chin, 2012-06-12 Pharmaceuticals companies, biotech companies, and CROs, regardless of size, all face the same challenge of managing costs and operational execution associated with bringing a valuable drugs and devices to market. Because of timeline pressures and cost as well as the growing interest in neglected diseases and diseases affecting the emerging nations, clinical trials are increasingly conducted in emerging markets and developing countries where infrastructure, leadership, skilled personnel and a governance are at a premium. Working with academics, regulatory professionals, safety officers, experts from the pharma industry and CROs, the editors have put together this up-to-date, step-by-step guide book to building and enhancing global clinical trial capacity in emerging markets and developing countries. This book covers the design, conduct, and tools to build and/or enhance human capacity to execute such trials, appealing to individuals in health ministries, pharmaceutical companies, world health organizations, academia, industry, and non-governmental organizations (NGOs) who are managing global clinical trials. - Gives medical professionals the business tools needed to effectively execute clinical trials throughout the world - Provides real world international examples which illustrate the practical translation of principles - Includes forms, templates, and additional references for standardization in a number of global scenarios |
| financial disclosure form clinical trials: Getting Your Affairs in Order , 1988 |
| financial disclosure form clinical trials: International Ethical Guidelines for Biomedical Research Involving Human Subjects Council for International Organizations of Medical Sciences, 2002 The present text is the revised/updated version of the CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects. It consists of 21 guidelines with commentaries. A prefatory section outlines the historical background and the revision process and includes an introduction an account of earlier instruments and guidelines a statement of ethical principles and a preamble. An Appendix lists the items to be included in the research protocol to be submitted for scientific and ethical review and clearance. The Guidelines relate mainly to ethical justification and scientific validity of research; ethical review; informed consent; vulnerability - of individuals groups communities and populations; women as research subjects; equity regarding burdens and benefits; choice of control in clinical trials; confidentiality; compensation for injury; strengthening of national or local capacity for ethical review; and obligations of sponsors to provide health-care services. They are designed to be of use to countries in defining national policies on the ethics of biomedical research involving human subjects applying ethical standards in local circumstances and establishing or improving ethical review mechanisms. A particular aim is to reflect the conditions and the needs of low-resource countries and the implications for multinational or transnational research in which they may be partners. |
| financial disclosure form clinical trials: Overview of the Privacy Act of 1974 United States. Department of Justice. Privacy and Civil Liberties Office, 2010 The Overview of the Privacy Act of 1974, prepared by the Department of Justice's Office of Privacy and Civil Liberties (OPCL), is a discussion of the Privacy Act's disclosure prohibition, its access and amendment provisions, and its agency recordkeeping requirements. Tracking the provisions of the Act itself, the Overview provides reference to, and legal analysis of, court decisions interpreting the Act's provisions. |
| financial disclosure form clinical trials: A Step-by-step Guide to Clinical Trials Marilyn Mulay, 2001 Provides a practical approach to understanding the components of a clinical research trial as well as the tools to conduct a well-organized study. Designed for those interested in developing or enhancing skills to coordinate all aspects of clinical trials such as regulatory requirements, budgeting, contracts, patient recruitments and participation, and gathering and recording clear, invaluable data. |
| financial disclosure form clinical trials: Cancer Clinical Trials Tomasz M. Beer, Larry Axmaker, 2012 A readable guide for anyone who is considering therapeutic options in addition to standard cancer therapy. The book seeks to share knowledge about cancer clinical trials with people living with cancer, their families and loved ones. |
| financial disclosure form clinical trials: Care at the Close of Life: Evidence and Experience Stephen J. McPhee, Margaret A. Winker, Michael W. Rabow, Steven Z. Pantilat, Amy J. Markowitz, 2010-10-04 From one of the world’s leading medical journals comes the definitive evidence-based, full-color guide to end-of-life and palliative care ...represents an important milestone in the evolution of care for people with advanced disease—-for which its editors and authors and JAMA should be rightly proud. It is wonderful that JAMA had the foresight to publish a series on this topic, which, as medicine has become more technologically advanced and subspecialized, is often overlooked and, sometimes worse, avoided....this book will be invaluable for front-line clinicians, and indeed all health care practitioners—as care at the close of life is a part of almost all of medicine’s specialties and settings.--Irene J. Higginson, BMBS, PhD, FPPHM, FRCP; Dept. of Palliative Care, Policy, & Rehabilitation; Cicely Saunders Institute; King's College London (from the foreword) A new addition to the JAMAevidence series, Care at the Close of Life: Evidence and Experience offers evidence-based and clinical expert guidance on caring for patients with life-limiting illness, incorporating the words and perspectives of affected patients, their families, and treating clinicians. Organized by these actual clinical cases, the book is based on the acclaimed 7-year series of 42 articles, originally published in JAMA as “Perspectives on Care at the Close of Life,” and now thoroughly updated as chapters and featuring extensive never-before-published material. Care at the Close of Life covers are a wide range of clinical syndromes, disease processes, communication challenges, health-care delivery settings, and issues faced by patients, including withdrawal of dialysis and other life-sustaining measures, cross-cultural approaches, and the role of chemotherapy. Throughout the book, emphasis is on the principles of palliative care, with the patient and family at the center of care, and with attention given to all problems—physical, psychological, social, and spiritual. Reflecting this focus, each chapter begins with a patient case study to introduce the clinical problem, followed by “perspectives” that draw on extensive, real-world dialogue between clinicians, patients, and families. Internationally renowned authors then review the typical challenges illustrated by the case, offering state-of-the-art, evidence-based assessment and treatment approaches. Features Fully revised and updated text with new evidence and references, including the search methodology for each chapter’s update Evidence-based orientation presents the current state of knowledge in the care of terminally ill patients and support for their families and caregivers Practical clinical guidance and approaches from international experts in palliative care Self-assessment Q&A, for reinforcing your knowledge of each chapter’s content and for preparing for exams A useful Glossary of acronyms, terms, and tests Updated Resources for each chapter offer current, authoritative sources of diagnostic and treatment information that can help you optimize palliative care Medline PubMed ID numbers facilitate quick, convenient access to references |
| financial disclosure form clinical trials: The Future of Drug Safety Institute of Medicine, Board on Population Health and Public Health Practice, Committee on the Assessment of the US Drug Safety System, 2007-03-27 In the wake of publicity and congressional attention to drug safety issues, the Food and Drug Administration (FDA) requested the Institute of Medicine assess the drug safety system. The committee reported that a lack of clear regulatory authority, chronic underfunding, organizational problems, and a scarcity of post-approval data about drugs' risks and benefits have hampered the FDA's ability to evaluate and address the safety of prescription drugs after they have reached the market. Noting that resources and therefore efforts to monitor medications' riskâ€benefit profiles taper off after approval, The Future of Drug Safety offers a broad set of recommendations to ensure that consideration of safety extends from before product approval through the entire time the product is marketed and used. |
| financial disclosure form clinical trials: Clinical Trials in the Neurosciences Katherine M. Woodbury-Harris, Bruce M. Coull, 2009 A properly designed and executed clinical trial that addresses an import question and delivers a definitive result can change the practice of medicine worldwide. This book encompasses a bench-to-bedside approach and serves as an excellent guidance for translating preclinical studies to early phase I/II and phase III trials. In the first part, the book covers preclinical science with respect to animal models of various neurological diseases, FDA requirements for preclinical studies, translation of animal to patient studies and scaling up from animal to human studies. In the second part, the design of phase I/II trials and the use of biomarkers as surrogate endpoints are discussed. With regard to phase III trials, FDA and European requirements, specific design issues, relevant clinical endpoints as well as data management and quality are examined. Topics specific to multicenter trials, such as design, recruitment of special populations, monitoring, ethical and consent issues are also covered. Finally, genetics, gene therapy, imaging and surgical devices are reviewed.This publication is highly recommended to clinician researchers, such as neurologists, neurosurgeons, pediatric neurologists and neonatologists, who want to design and conduct clinical trials in the neuroscience, but also to nurses, research coordinators and clinical pharmacologists. |
| financial disclosure form clinical trials: Handbook of Pharmaceutical Public Policy Thomas Fulda, 2007-07-25 Get an invaluable view of the impact of economics and politics on pharmaceuticals in the United States Pharmacy and pharmaceutical drug use are highly regulated and the various regulatory forces interact with diverse goals. Pharmaceutical Public Policy is a comprehensive review of the legislation, trends, business developments, and policy interpretations that have shaped drug use during the last 50 years. This unique single source explains drug regulatory activity, the major insurance and payment systems, and the impact of economics and politics on drug use in the United States. Leading experts provide a thorough and objective look at public policy issues, making this text perfect for upper level undergraduate and graduate level pharmacy, medical, and public health educators and students. Pharmacists and pharmacy students must learn more than just the physical sciences and clinical aspects of the pharmaceutical industry. The rationale for policies, rules, and regulations is integral to understanding how to best serve patients and make the entire pharmaceutical sector more equitable and cost-effective. Pharmaceutical Public Policy examines the most pressing issues facing the industry, including control of the rising costs for drugs and ensuring correct drug usage by patients. This insightful text offers an in depth perspective of the policies and the debates that surround them. Chapters are well-referenced and many include helpful figures and tables to illustrate facts and ideas. Topics in Pharmaceutical Public Policy include: pharmacy law and regulation Medicare and prescription drug coverage FDA drug approval process Medicaid and prescription drugs public health pharmacy Department of Veterans Affairs pharmacy programs Department of Defense pharmacy programs innovative state drug program practices state and federal regulation of pharmacy the future of the pharmaceutical industry managed care pharmacy PBM’s (pharmacy benefit managers) risk minimization importation and reimportation biotechnology and pharmacogenetics policy and issues product promotion competition between drugs drug insurance design patient compliance abuse of prescription drugs health care systems and insurance in Europe much more Pharmaceutical Public Policy is a one-of-a-kind resource that explains just who the players are and the complexity of the issues that are examined in most pharmaceutical policy debates, and is perfect for pharmacy students, educators, other health professionals, trade association leaders, and policymakers. |
| financial disclosure form clinical trials: Ethics and the Pharmaceutical Industry Michael A. Santoro, Thomas M. Gorrie, 2005-10-31 Despite the pharmaceutical industry's notable contributions to human progress, including the development of miracle drugs for treating cancer, AIDS, and heart disease, there is a growing tension between the industry and the public. Government officials and social critics have questioned whether the multibillion-dollar industry is fulfilling its social responsibilities. This doubt has been fueled by the national debate over drug pricing and affordable healthcare, and internationally by the battles against epidemic diseases, such as AIDS, in the developing world. Debates are raging over how the industry can and should be expected to act. The contributions in this book by leading figures in industry, government, NGOs, the medical community, and academia discuss and propose solutions to the ethical dilemmas of drug industry behavior. They examine such aspects as the role of intellectual property rights and patent protection, the moral and economic requisites of research and clinical trials, drug pricing, and marketing. |
| financial disclosure form clinical trials: Stress Echocardiography Eugenio Picano, 2015-10-06 This sixth edition is enriched by over 300 figures, 150 tables and a video-companion collecting more than 100 cases also presented in the format of short movies and teaching cartoons. This extensively revised and enlarged edition of this long-seller documents the very significant advances made since the fifth (2009) edition and is entirely written by Eugenio Picano, a pioneer in the field sharing his lifetime experience with the help of an international panel of 50 contributors from 22 countries representing some of the best available knowledge and expertise in their respective field. In a societal and economic climate of increasing pressure for appropriate, justified and optimized imaging, stress echocardiography offers the great advantages of being radiation-free, relatively low cost, and with a staggering versatility: we can get more (information) with less (cost and risk). For a long time, the scope and application of stress echo remained focused on coronary artery disease. In the last ten years, it has exploded in its breadth and variety of applications. From a black-and-white, one-fits-all approach (wall motion by 2D-echo in the patient with known or suspected coronary artery disease) now we have moved on to a omnivorous, next-generation laboratory employing a variety of technologies (from M-Mode to 2D and pulsed, continuous, color and tissue Doppler, to lung ultrasound and real time 3D echo, 2D speckle tracking and myocardial contrast echo) on patients covering the entire spectrum of severity (from elite athletes to patients with end-stage heart failure) and ages (from children with congenital heart disease to the elderly with low-flow, low-gradient aortic stenosis). |
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