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| double blinded study definition: 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. |
| double blinded study definition: 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. |
| double blinded study definition: 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. |
| double blinded study definition: 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. |
| double blinded study definition: Encyclopedia of Child Behavior and Development Sam Goldstein, Jack A. Naglieri, 2010-11-23 This reference work breaks new ground as an electronic resource. Utterly comprehensive, it serves as a repository of knowledge in the field as well as a frequently updated conduit of new material long before it finds its way into standard textbooks. |
| double blinded study definition: How to Practice Academic Medicine and Publish from Developing Countries? Samiran Nundy, Atul Kakar, Zulfiqar A. Bhutta, 2021-10-23 This is an open access book. The book provides an overview of the state of research in developing countries – Africa, Latin America, and Asia (especially India) and why research and publications are important in these regions. It addresses budding but struggling academics in low and middle-income countries. It is written mainly by senior colleagues who have experienced and recognized the challenges with design, documentation, and publication of health research in the developing world. The book includes short chapters providing insight into planning research at the undergraduate or postgraduate level, issues related to research ethics, and conduct of clinical trials. It also serves as a guide towards establishing a research question and research methodology. It covers important concepts such as writing a paper, the submission process, dealing with rejection and revisions, and covers additional topics such as planning lectures and presentations. The book will be useful for graduates, postgraduates, teachers as well as physicians and practitioners all over the developing world who are interested in academic medicine and wish to do medical research. |
| double blinded study definition: 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. |
| double blinded study definition: FDA Approval of New Drugs United States. Food and Drug Administration, 1971 |
| double blinded study definition: Cochrane Handbook for Systematic Reviews of Interventions Julian P. T. Higgins, Sally Green, 2008-11-24 Healthcare providers, consumers, researchers and policy makers are inundated with unmanageable amounts of information, including evidence from healthcare research. It has become impossible for all to have the time and resources to find, appraise and interpret this evidence and incorporate it into healthcare decisions. Cochrane Reviews respond to this challenge by identifying, appraising and synthesizing research-based evidence and presenting it in a standardized format, published in The Cochrane Library (www.thecochranelibrary.com). The Cochrane Handbook for Systematic Reviews of Interventions contains methodological guidance for the preparation and maintenance of Cochrane intervention reviews. Written in a clear and accessible format, it is the essential manual for all those preparing, maintaining and reading Cochrane reviews. Many of the principles and methods described here are appropriate for systematic reviews applied to other types of research and to systematic reviews of interventions undertaken by others. It is hoped therefore that this book will be invaluable to all those who want to understand the role of systematic reviews, critically appraise published reviews or perform reviews themselves. |
| double blinded study definition: Dictionary of Pharmaceutical Medicine Gerhard Nahler, 2013-06-29 This dictionary is aimed primarily at the beginners entering the new discipline of Pharmaceutical Medicine, an area comprising aspects of toxicology, pharmacology, pharmaceutics, epidemiology, statistics, drug regulatory and legal affairs, medicine and marketing. But also more experienced colleagues in departments engaged in clinical development as well as researchers and marketing experts in the pharmaceutical industry will find concise and up-to-date information. The book is completed by a list of a about 1000 abbreviations encountered in pharmaceutical medicine and a compilation of important addresses of national and international health authorities. |
| double blinded study definition: Introductory Business Statistics 2e Alexander Holmes, Barbara Illowsky, Susan Dean, 2023-12-13 Introductory Business Statistics 2e aligns with the topics and objectives of the typical one-semester statistics course for business, economics, and related majors. The text provides detailed and supportive explanations and extensive step-by-step walkthroughs. The author places a significant emphasis on the development and practical application of formulas so that students have a deeper understanding of their interpretation and application of data. Problems and exercises are largely centered on business topics, though other applications are provided in order to increase relevance and showcase the critical role of statistics in a number of fields and real-world contexts. The second edition retains the organization of the original text. Based on extensive feedback from adopters and students, the revision focused on improving currency and relevance, particularly in examples and problems. This is an adaptation of Introductory Business Statistics 2e by OpenStax. You can access the textbook as pdf for free at openstax.org. Minor editorial changes were made to ensure a better ebook reading experience. Textbook content produced by OpenStax is licensed under a Creative Commons Attribution 4.0 International License. |
| double blinded study definition: Encyclopedia of Research Design Neil J. Salkind, 2010-06-22 Comprising more than 500 entries, the Encyclopedia of Research Design explains how to make decisions about research design, undertake research projects in an ethical manner, interpret and draw valid inferences from data, and evaluate experiment design strategies and results. Two additional features carry this encyclopedia far above other works in the field: bibliographic entries devoted to significant articles in the history of research design and reviews of contemporary tools, such as software and statistical procedures, used to analyze results. It covers the spectrum of research design strategies, from material presented in introductory classes to topics necessary in graduate research; it addresses cross- and multidisciplinary research needs, with many examples drawn from the social and behavioral sciences, neurosciences, and biomedical and life sciences; it provides summaries of advantages and disadvantages of often-used strategies; and it uses hundreds of sample tables, figures, and equations based on real-life cases.--Publisher's description. |
| double blinded study definition: Neuroscience Trials of the Future National Academies of Sciences, Engineering, and Medicine, Health and Medicine Division, Board on Health Sciences Policy, Forum on Neuroscience and Nervous System Disorders, 2016-11-07 On March 3-4, 2016, the National Academies of Sciences, Engineering, and Medicine's Forum on Neuroscience and Nervous System Disorders held a workshop in Washington, DC, bringing together key stakeholders to discuss opportunities for improving the integrity, efficiency, and validity of clinical trials for nervous system disorders. Participants in the workshop represented a range of diverse perspectives, including individuals not normally associated with traditional clinical trials. The purpose of this workshop was to generate discussion about not only what is feasible now, but what may be possible with the implementation of cutting-edge technologies in the future. |
| double blinded study definition: Clinical Pharmacy Education, Practice and Research Dixon Thomas, 2018-11-23 Clinical Pharmacy Education, Practice and Research offers readers a solid foundation in clinical pharmacy and related sciences through contributions by 83 leading experts in the field from 25 countries. This book stresses educational approaches that empower pharmacists with patient care and research competencies. The learning objectives and writing style of the book focus on clarifying the concepts comprehensively for a pharmacist, from regular patient counseling to pharmacogenomics practice. It covers all interesting topics a pharmacist should know. This book serves as a basis to standardize and coordinate learning to practice, explaining basics and using self-learning strategies through online resources or other advanced texts. With an educational approach, it guides pharmacy students and pharmacists to learn quickly and apply. Clinical Pharmacy Education, Practice and Research provides an essential foundation for pharmacy students and pharmacists globally. - Covers the core information needed for pharmacy practice courses - Includes multiple case studies and practical situations with 70% focused on practical clinical pharmacology knowledge - Designed for educational settings, but also useful as a refresher for advanced students and researchers |
| double blinded study definition: Critical Appraisal of Epidemiological Studies and Clinical Trials Mark Elwood, 2007-02-22 This book presents a logical system of critical appraisal, to allow readers to evaluate studies and to carry out their own studies more effectively. This system emphasizes the central importance of cause and effect relationships. Its great strength is that it is applicable to a wide range of issues, and both to intervention trials and observational studies. This system unifies the often different approaches used in epidemiology, health services research, clinical trials, and evidence-based medicine, starting from a logical consideration of cause and effect. The author's approach to the issues of study design, selection of subjects, bias, confounding, and the place of statistical methods has been praised for its clarity and interest. Systematic reviews, meta-analysis, and the applications of this logic to evidence-based medicine, knowledge-based health care, and health practice and policy are discussed. Current and often controversial examples are used, including screening for prostate cancer, publication bias in psychiatry, public health issues in developing countries, and conflicts between observational studies and randomized trials. Statistical issues are explained clearly without complex mathematics, and the most useful methods are summarized in the appendix. The final chapters give six applications of the critical appraisal of major studies: randomized trials of medical treatment and prevention, a prospective and a retrospective cohort study, a small matched case-control study, and a large case-control study. In these chapters, sections of the original papers are reproduced and the original studies placed in context by a summary of current developments. |
| double blinded study definition: Drug Discovery and Evaluation: Methods in Clinical Pharmacology H.Gerhard Vogel, Jochen Maas, Alexander Gebauer, 2010-12-15 Drug Discovery and Evaluation has become a more and more difficult, expensive and time-consuming process. The effect of a new compound has to be detected by in vitro and in vivo methods of pharmacology. The activity spectrum and the potency compared to existing drugs have to be determined. As these processes can be divided up stepwise we have designed a book series Drug Discovery and Evaluation in the form of a recommendation document. The methods to detect drug targets are described in the first volume of this series Pharmacological Assays comprising classical methods as well as new technologies. Before going to man, the most suitable compound has to be selected by pharmacokinetic studies and experiments in toxicology. These preclinical methods are described in the second volume „Safety and Pharmacokinetic Assays. Only then are first studies in human beings allowed. Special rules are established for Phase I studies. Clinical pharmacokinetics are performed in parallel with human studies on tolerability and therapeutic effects. Special studies according to various populations and different therapeutic indications are necessary. These items are covered in the third volume: „Methods in Clinical Pharmacology. |
| double blinded study definition: 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. |
| double blinded study definition: Dietary Supplements United States. Federal Trade Commission. Bureau of Consumer Protection, 1998 |
| double blinded study definition: Principles and Practice of Clinical Trial Medicine Richard Chin, Bruce Y Lee, 2008-07-25 Clinical trials are an important part of medicine and healthcare today, deciding which treatments we use to treat patients. Anyone involved in healthcare today must know the basics of running and interpreting clinical trial data. Written in an easy-to-understand style by authors who have considerable expertise and experience in both academia and industry, Principles and Practice of Clinical Trial Medicine covers all of the basics of clinical trials, from legal and ethical issues to statistics, to patient recruitment and reporting results. - Jargon-free writing style enables those with less experience to run their own clinical trials and interpret data - Book contains an ideal mix of theory and practice so researchers will understand both the rationale and logistics to clinical trial medicine - Expert authorship whose experience includes running clinical trials in an academic as well as industry settings - Numerous illustrations reinforce and elucidate key concepts and add to the book's overall pedagogy |
| double blinded study definition: Systematic Reviews in Health Care Matthias Egger, George Davey-Smith, Douglas Altman, 2008-04-15 The second edition of this best-selling book has been thoroughly revised and expanded to reflect the significant changes and advances made in systematic reviewing. New features include discussion on the rationale, meta-analyses of prognostic and diagnostic studies and software, and the use of systematic reviews in practice. |
| double blinded study definition: Identifying the Culprit National Research Council, Division of Behavioral and Social Sciences and Education, Committee on Law and Justice, Policy and Global Affairs, Committee on Science, Technology, and Law, Committee on Scientific Approaches to Understanding and Maximizing the Validity and Reliability of Eyewitness Identification in Law Enforcement and the Courts, 2015-01-16 Identifying the Culprit: Assessing Eyewitness Identification makes the case that better data collection and research on eyewitness identification, new law enforcement training protocols, standardized procedures for administering line-ups, and improvements in the handling of eyewitness identification in court can increase the chances that accurate identifications are made. This report explains the science that has emerged during the past 30 years on eyewitness identifications and identifies best practices in eyewitness procedures for the law enforcement community and in the presentation of eyewitness evidence in the courtroom. In order to continue the advancement of eyewitness identification research, the report recommends a focused research agenda. |
| double blinded study definition: Modern Epidemiology Kenneth J. Rothman, Sander Greenland, Timothy L. Lash, 2008 The thoroughly revised and updated Third Edition of the acclaimed Modern Epidemiology reflects both the conceptual development of this evolving science and the increasingly focal role that epidemiology plays in dealing with public health and medical problems. Coauthored by three leading epidemiologists, with sixteen additional contributors, this Third Edition is the most comprehensive and cohesive text on the principles and methods of epidemiologic research. The book covers a broad range of concepts and methods, such as basic measures of disease frequency and associations, study design, field methods, threats to validity, and assessing precision. It also covers advanced topics in data analysis such as Bayesian analysis, bias analysis, and hierarchical regression. Chapters examine specific areas of research such as disease surveillance, ecologic studies, social epidemiology, infectious disease epidemiology, genetic and molecular epidemiology, nutritional epidemiology, environmental epidemiology, reproductive epidemiology, and clinical epidemiology. |
| double blinded study definition: Principles and Practice of Clinical Trials Steven Piantadosi, Curtis L. Meinert, 2022-07-19 This is a comprehensive major reference work for our SpringerReference program covering clinical trials. Although the core of the Work will focus on the design, analysis, and interpretation of scientific data from clinical trials, a broad spectrum of clinical trial application areas will be covered in detail. This is an important time to develop such a Work, as drug safety and efficacy emphasizes the Clinical Trials process. Because of an immense and growing international disease burden, pharmaceutical and biotechnology companies continue to develop new drugs. Clinical trials have also become extremely globalized in the past 15 years, with over 225,000 international trials ongoing at this point in time. Principles in Practice of Clinical Trials is truly an interdisciplinary that will be divided into the following areas: 1) Clinical Trials Basic Perspectives 2) Regulation and Oversight 3) Basic Trial Designs 4) Advanced Trial Designs 5) Analysis 6) Trial Publication 7) Topics Related Specific Populations and Legal Aspects of Clinical Trials The Work is designed to be comprised of 175 chapters and approximately 2500 pages. The Work will be oriented like many of our SpringerReference Handbooks, presenting detailed and comprehensive expository chapters on broad subjects. The Editors are major figures in the field of clinical trials, and both have written textbooks on the topic. There will also be a slate of 7-8 renowned associate editors that will edit individual sections of the Reference. |
| double blinded study definition: The Social Impact of AIDS in the United States National Research Council, Division of Behavioral and Social Sciences and Education, Commission on Behavioral and Social Sciences and Education, Panel on Monitoring the Social Impact of the AIDS Epidemic, 1993-02-01 Europe's Black Death contributed to the rise of nation states, mercantile economies, and even the Reformation. Will the AIDS epidemic have similar dramatic effects on the social and political landscape of the twenty-first century? This readable volume looks at the impact of AIDS since its emergence and suggests its effects in the next decade, when a million or more Americans will likely die of the disease. The Social Impact of AIDS in the United States addresses some of the most sensitive and controversial issues in the public debate over AIDS. This landmark book explores how AIDS has affected fundamental policies and practices in our major institutions, examining: How America's major religious organizations have dealt with sometimes conflicting values: the imperative of care for the sick versus traditional views of homosexuality and drug use. Hotly debated public health measures, such as HIV antibody testing and screening, tracing of sexual contacts, and quarantine. The potential risk of HIV infection to and from health care workers. How AIDS activists have brought about major change in the way new drugs are brought to the marketplace. The impact of AIDS on community-based organizations, from volunteers caring for individuals to the highly political ACT-UP organization. Coping with HIV infection in prisons. Two case studies shed light on HIV and the family relationship. One reports on some efforts to gain legal recognition for nonmarital relationships, and the other examines foster care programs for newborns with the HIV virus. A case study of New York City details how selected institutions interact to give what may be a picture of AIDS in the future. This clear and comprehensive presentation will be of interest to anyone concerned about AIDS and its impact on the country: health professionals, sociologists, psychologists, advocates for at-risk populations, and interested individuals. |
| double blinded study definition: Acupuncture Gabriel Stux, Bruce Pomeranz, 2012-12-06 Following an introduction to the philosophical and theoreti- cal background of traditional Chinese medicine, the dia- gnostic system is presented: the Chinese system of channels and functional organs, the significance of pointsand point categories, methods of needling and moxibustion. There is a chapter on treatment based on western diagnosis. |
| double blinded study definition: A Dictionary of Epidemiology Miquel S. Porta, Sander Greenland, Miguel Hernán, Isabel dos Santos Silva, John M. Last, 2014 This edition is the most updated since its inception, is the essential text for students and professionals working in and around epidemiology or using its methods. It covers subject areas - genetics, clinical epidemiology, public health practice/policy, preventive medicine, health promotion, social sciences and methods for clinical research. |
| double blinded study definition: The Double-bind Dilemma for Women in Leadership , 2007 |
| double blinded study definition: 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. |
| double blinded study definition: 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. |
| double blinded study definition: Randomized Controlled Trials Alehandro R. Jadad, Murray W. Enkin, 2007-07-23 Randomized controlled trials are one of the most powerful and revolutionary tools of research. This book is a convenient and accessible description of the underlying principles and practice of randomized controlled trials and their role in clinical decision-making. Structured in a jargon-free question-and-answer format, each chapter provides concise and understandable information on a different aspect of randomized controlled trials, from the basics of trial design and terminology to the interpretation of results and their use in driving evidence-based medicine. The authors end each chapter with their musings, going beyond the evidence or citations, and sometimes even beyond orthodox correctness to share their thoughts and concerns about different aspects of randomized controlled trials, and their role within the health system. Updated to include insights from the last decade, this second edition challenges over-reliance on randomized controlled trials by debating their strengths and limitations and discussing their optimal use in modern healthcare. It also includes a new and increasingly relevant chapter on the ethics of randomized trials. World renowned writers and thinkers Drs Jadad and Enkin bring you this invaluable book for busy health professionals who wish to understand the theory of randomized controlled trials and their influence on clinical, research or policy decisions. |
| double blinded study definition: Practical Biostatistics Mendel Suchmacher, Mauro Geller, 2012-07-26 Evidence-based medicine aims to apply the best available evidence gained from the scientific method to medical decision making. It is a practice that uses statistical analysis of scientific methods and outcomes to drive further experimentation and diagnosis. The profusion of evidence-based medicine in medical practice and clinical research has produced a need for life scientists and clinical researchers to assimilate biostatistics into their work to meet efficacy and practical standards. Practical Biostatistics provides researchers, medical professionals, and students with a friendly, practical guide to biostatistics. With a detailed outline of implementation steps complemented by a review of important topics, this book can be used as a quick reference or a hands-on guide to effectively incorporate biostatistics in clinical trials. - Customized presentation for biological investigators with examples taken from current clinical trials in multiple disciplines - Clear and concise definitions and examples provide a pragmatic guide to bring clarity to the applications of statistics in improving human health - Addresses the challenge of assimilation of mathematical concepts to better interpret literature, to build stronger studies, to present research effectively, and to improve communication with supporting biostatisticians |
| double blinded study definition: The Great Mental Models, Volume 1 Shane Parrish, Rhiannon Beaubien, 2024-10-15 Discover the essential thinking tools you’ve been missing with The Great Mental Models series by Shane Parrish, New York Times bestselling author and the mind behind the acclaimed Farnam Street blog and “The Knowledge Project” podcast. This first book in the series is your guide to learning the crucial thinking tools nobody ever taught you. Time and time again, great thinkers such as Charlie Munger and Warren Buffett have credited their success to mental models–representations of how something works that can scale onto other fields. Mastering a small number of mental models enables you to rapidly grasp new information, identify patterns others miss, and avoid the common mistakes that hold people back. The Great Mental Models: Volume 1, General Thinking Concepts shows you how making a few tiny changes in the way you think can deliver big results. Drawing on examples from history, business, art, and science, this book details nine of the most versatile, all-purpose mental models you can use right away to improve your decision making and productivity. This book will teach you how to: Avoid blind spots when looking at problems. Find non-obvious solutions. Anticipate and achieve desired outcomes. Play to your strengths, avoid your weaknesses, … and more. The Great Mental Models series demystifies once elusive concepts and illuminates rich knowledge that traditional education overlooks. This series is the most comprehensive and accessible guide on using mental models to better understand our world, solve problems, and gain an advantage. |
| double blinded study definition: Classical Competing Risks Martin J. Crowder, 2001-05-11 If something can fail, it can often fail in one of several ways and sometimes in more than one way at a time. There is always some cause of failure, and almost always, more than one possible cause. In one sense, then, survival analysis is a lost cause. The methods of Competing Risks have often been neglected in the survival analysis literature. |
| double blinded study definition: Blindspot Mahzarin R. Banaji, Anthony G. Greenwald, 2016-08-16 “Accessible and authoritative . . . While we may not have much power to eradicate our own prejudices, we can counteract them. The first step is to turn a hidden bias into a visible one. . . . What if we’re not the magnanimous people we think we are?”—The Washington Post I know my own mind. I am able to assess others in a fair and accurate way. These self-perceptions are challenged by leading psychologists Mahzarin R. Banaji and Anthony G. Greenwald as they explore the hidden biases we all carry from a lifetime of exposure to cultural attitudes about age, gender, race, ethnicity, religion, social class, sexuality, disability status, and nationality. “Blindspot” is the authors’ metaphor for the portion of the mind that houses hidden biases. Writing with simplicity and verve, Banaji and Greenwald question the extent to which our perceptions of social groups—without our awareness or conscious control—shape our likes and dislikes and our judgments about people’s character, abilities, and potential. In Blindspot, the authors reveal hidden biases based on their experience with the Implicit Association Test, a method that has revolutionized the way scientists learn about the human mind and that gives us a glimpse into what lies within the metaphoric blindspot. The title’s “good people” are those of us who strive to align our behavior with our intentions. The aim of Blindspot is to explain the science in plain enough language to help well-intentioned people achieve that alignment. By gaining awareness, we can adapt beliefs and behavior and “outsmart the machine” in our heads so we can be fairer to those around us. Venturing into this book is an invitation to understand our own minds. Brilliant, authoritative, and utterly accessible, Blindspot is a book that will challenge and change readers for years to come. Praise for Blindspot “Conversational . . . easy to read, and best of all, it has the potential, at least, to change the way you think about yourself.”—Leonard Mlodinow, The New York Review of Books “Banaji and Greenwald deserve a major award for writing such a lively and engaging book that conveys an important message: Mental processes that we are not aware of can affect what we think and what we do. Blindspot is one of the most illuminating books ever written on this topic.”—Elizabeth F. Loftus, Ph.D., distinguished professor, University of California, Irvine; past president, Association for Psychological Science; author of Eyewitness Testimony |
| double blinded study definition: Randomised Controlled Trials Alejandro R. Jadad, 1998 The contributors to this study present a balanced view of the strengths and weaknesses of randomised controlled trials in the medical setting. They cover all the essential issues without using statistics. |
| double blinded study definition: Principles of Clinical Research Ignazio Di Giovanna, Gareth Hayes, 2001 In an arena which has seen rapid change over the past decade, this work provides a comprehensive and up-to-date guide to the planning, organization and management of clinical trials. |
| double blinded study definition: 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. |
| double blinded study definition: Meaning, Medicine, and the "placebo Effect" Daniel E. Moerman, 2002 |
| double blinded study definition: Science of the Placebo Harry Guess, Linda Engel, Arthur Kleinman, John Kusek, 2002-03-15 Based on a meeting in November 2000, this book brings together researchers from a wide range of disciplines to examine the biological, behavioral, social, cultural and ethical aspects related to the placebo effect. Perspectives on the necessity for including a placebo in randomized clinical trials will also be examined. This is the first attempt to examine the evidence-base of the placebo effect and will provide important information for clinicans. |
| double blinded study definition: Fundamentals of Clinical Trials Lawrence M. Friedman, Curt D. Furberg, David L. DeMets, 2010-09-09 The clinical trial is “the most definitive tool for evaluation of the applicability of clinical research.” It represents “a key research activity with the potential to improve the quality of health care and control costs through careful comparison of alternative treatments” [1]. It has been called on many occasions, “the gold st- dard” against which all other clinical research is measured. Although many clinical trials are of high quality, a careful reader of the medical literature will notice that a large number have deficiencies in design, conduct, analysis, presentation, and/or interpretation of results. Improvements have occurred over the past few decades, but too many trials are still conducted without adequate attention to its fundamental principles. Certainly, numerous studies could have been upgraded if the authors had had a better understanding of the fundamentals. Since the publication of the first edition of this book, a large number of other texts on clinical trials have appeared, most of which are indicated here [2–21]. Several of them, however, discuss only specific issues involved in clinical trials. Additionally, many are no longer current. The purpose of this fourth edition is to update areas in which major progress has been made since the publication of the third edition. We have revised most chapters considerably and added one on ethical issues. |
Considerations for open-label clinical trials: design, conduc…
Double-blind: often used to describe a fully blind trial, but the term double-blind is vague and, when used, should be …
STANDARD OPERATING PROCEDURE 41 Blinding an…
“A procedure in which one or more parties to the study are kept unaware of the treatment assignment(s).” Single, …
Double-blind, single-blind, observer-blind: - when and h…
Blinding terminology emerged when Benjamin Franklin (18th century) and colleagues actually blindfolded …
Limitations of the Double-Blind Pharmaceutical Study - PNI
subject is receiving, the study is double-blind. The double-blind, controlled medication study (DBCMS) has …
Randomized Controlled Trials (Experimental Studies)
When only study participants are unaware of their treatment status, but investigators and analysts are aware of treatment …
Secure Data Office: An independent team that can c…
In a double blinded study, it is critical that the subjects as well as investigators and everybody involved in interpretation …
APPENDIX I UNBLINDING PROCEDURES I.1 Purpose I …
This appendix defines the concepts of “blinding” and “unblinding” the treatment assignment of study participants …
Considerations for open-label clinical trials: design, conduct, …
Double-blind: often used to describe a fully blind trial, but the term double-blind is vague and, when used, should be clearly defined as to how blinding was conducted and who exactly was...
STANDARD OPERATING PROCEDURE 41 Blinding and …
“A procedure in which one or more parties to the study are kept unaware of the treatment assignment(s).” Single, double & triple blind The terms ‘single-blind’ ‘double blind’ or ‘triple …
Definitions of blinding in randomised controlled trials of ...
abstract described the study as ‘double-blind’, but the body of the manuscript provided more details about who was blinded, we considered this a discrepancy.
Double-blind, single-blind, observer-blind: - when and how
Blinding terminology emerged when Benjamin Franklin (18th century) and colleagues actually blindfolded participants to shield them from knowledge in their assessments of the therapeutic …
Limitations of the Double-Blind Pharmaceutical Study - PNI
subject is receiving, the study is double-blind. The double-blind, controlled medication study (DBCMS) has become a standard in medical research. Essentially, the study is double-blind …
Randomized Controlled Trials (Experimental Studies)
When only study participants are unaware of their treatment status, but investigators and analysts are aware of treatment status, the trial is called single-blinded. When both the participants and …
Secure Data Office: An independent team that can come to …
In a double blinded study, it is critical that the subjects as well as investigators and everybody involved in interpretation and analysis of the trial outcome measurements is unaware of the …
APPENDIX I UNBLINDING PROCEDURES I.1 Purpose I-1 I.2 …
This appendix defines the concepts of “blinding” and “unblinding” the treatment assignment of study participants (and/or their parents/guardians), provides guidelines for when to unblind, …
Common types of clinical trial design, study objectives, …
• Double-blind – Patient and investigator blind • Single-blind – Patient blind • Open • Blinded independent review
Blinding in randomised trials: hiding who got what - The Lancet
Although double blinding (blinding investigators, participants, and outcome assessors) indicates a strong design, trials that are not double blinded should not automatically be deemed inferior. …
CLINICAL STUDY PROTOCOL
This is a Phase 1 randomized, double blinded, placebo-controlled, single dose escalation study to evaluate safety, tolerability, PK, and immunogenicity of OsrHSA in healthy volunteers (See …
Placebos and Blinding in Randomized Controlled Cancer …
Placebos, defined as inert substances with no pharmacologic activity, are commonly used in double-blind, randomized controlled clinical trials.
Randomization Design for a Double-Blinded IIT Clinical …
Full randomization oversight by investigator-sponsor. Ensure randomization remains double-blinded. Minimize randomization and cohort assignment errors. Successfully randomize and …
Contemporary Clinical Trials - SPRIM
Confusion in blinding terminology. The double-blind RCT is widely considered the gold standard study design that most convincingly demonstrates the effectiveness of a product or …
What does “single-blind” or “double-blind” Is an “adverse …
double-blind study means both the researcher (and team) plus the participant is unaware of what treatment or intervention the participant is receiving. This is the most accurate type of study as …
FDA Guidance: “Design Considerations for Pivotal Clinical ...
Double-masked (blinded), randomized, controlled, multi-center clinical trials (RCTs) are the “gold standard” for clinical outcome studies (but not necessarily for diagnostic clinical...
Statistical Analysis Plan - ClinicalTrials.gov
A Multicenter, Randomized, Double-Blinded, Placebo-Controlled 16-Week Study (with a 52-Week Open-Label Extension) to Assess the Safety and Efficacy of Etrasimod in Subjects with …
I.1 Purpose I.2 Scope - IMPAACT Network
This appendix defines the concepts of “blinding” and “unblinding” the treatment assignment of study participants (and/or their parents/guardians), provides guidelines for when to unblind, …
Basics of Clinical Trial Design-Design, Population, Intervention, …
• Gold standard: randomized double-blind clinical trial: – Attenuates influence of confounding covariates – Minimizes potential for bias
STATISTICAL ANALYSIS PLAN
EFC14028 is a Phase 3, multicenter, multinational, randomized, double-blind study comparing the efficacy and safety of avalglucosidase alfa and alglucosidase alfa (both at 20 mg/kg qow) in …
