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| define double blind study: 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. |
| define double blind study: 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. |
| define double blind study: 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. |
| define double blind study: 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. |
| define double blind study: 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. |
| define double blind study: Modern Methods of Clinical Investigation Institute of Medicine, Committee on Technological Innovation in Medicine, 1990-02-01 The very rapid pace of advances in biomedical research promises us a wide range of new drugs, medical devices, and clinical procedures. The extent to which these discoveries will benefit the public, however, depends in large part on the methods we choose for developing and testing them. Modern Methods of Clinical Investigation focuses on strategies for clinical evaluation and their role in uncovering the actual benefits and risks of medical innovation. Essays explore differences in our current systems for evaluating drugs, medical devices, and clinical procedures; health insurance databases as a tool for assessing treatment outcomes; the role of the medical profession, the Food and Drug Administration, and industry in stimulating the use of evaluative methods; and more. This book will be of special interest to policymakers, regulators, executives in the medical industry, clinical researchers, and physicians. |
| define double blind study: 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. |
| define double blind study: 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. |
| define double blind study: 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. |
| define double blind study: Talking Cures and Placebo Effects David A. Jopling, 2008-05-29 Psychodynamic psychotherapy and psychoanalysis have had to defend themselves from a barrage of criticisms throughout their history. In this book David Jopling argues that the changes achieved through therapy are really just functions of placebos that rally the mind's native healing powers. It is a bold new work that delivers yet another blow to Freud and his followers. |
| define double blind study: The Double-bind Dilemma for Women in Leadership , 2007 |
| define double blind study: 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. |
| define double blind study: 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. |
| define double blind study: FDA Approval of New Drugs United States. Food and Drug Administration, 1971 |
| define double blind study: The Health Effects of Cannabis and Cannabinoids National Academies of Sciences, Engineering, and Medicine, Health and Medicine Division, Board on Population Health and Public Health Practice, Committee on the Health Effects of Marijuana: An Evidence Review and Research Agenda, 2017-03-31 Significant changes have taken place in the policy landscape surrounding cannabis legalization, production, and use. During the past 20 years, 25 states and the District of Columbia have legalized cannabis and/or cannabidiol (a component of cannabis) for medical conditions or retail sales at the state level and 4 states have legalized both the medical and recreational use of cannabis. These landmark changes in policy have impacted cannabis use patterns and perceived levels of risk. However, despite this changing landscape, evidence regarding the short- and long-term health effects of cannabis use remains elusive. While a myriad of studies have examined cannabis use in all its various forms, often these research conclusions are not appropriately synthesized, translated for, or communicated to policy makers, health care providers, state health officials, or other stakeholders who have been charged with influencing and enacting policies, procedures, and laws related to cannabis use. Unlike other controlled substances such as alcohol or tobacco, no accepted standards for safe use or appropriate dose are available to help guide individuals as they make choices regarding the issues of if, when, where, and how to use cannabis safely and, in regard to therapeutic uses, effectively. Shifting public sentiment, conflicting and impeded scientific research, and legislative battles have fueled the debate about what, if any, harms or benefits can be attributed to the use of cannabis or its derivatives, and this lack of aggregated knowledge has broad public health implications. The Health Effects of Cannabis and Cannabinoids provides a comprehensive review of scientific evidence related to the health effects and potential therapeutic benefits of cannabis. This report provides a research agendaâ€outlining gaps in current knowledge and opportunities for providing additional insight into these issuesâ€that summarizes and prioritizes pressing research needs. |
| define double blind study: Smart Health Choices Les Irwig, 2008 Every day we make decisions about our health - some big and some small. What we eat, how we live and even where we live can affect our health. But how can we be sure that the advice we are given about these important matters is right for us? This book will provide you with the right tools for assessing health advice. |
| define double blind study: Dietary Supplements United States. Federal Trade Commission. Bureau of Consumer Protection, 1998 |
| define double blind study: Public Health Research Methods Greg Guest, Emily E. Namey, 2015 Providing a comprehensive foundation for planning, executing, and monitoring public health research of all types, this book goes beyond traditional epidemiologic research designs to cover technology-based approaches emerging in the new public health landscape. |
| define double blind study: 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. |
| define double blind study: 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. |
| define double blind study: 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. |
| define double blind study: Encyclopedia of Public Health Wilhelm Kirch, 2008-06-13 The Encyclopedic Reference of Public Health presents the most important definitions, principles and general perspectives of public health, written by experts of the different fields. The work includes more than 2,500 alphabetical entries. Entries comprise review-style articles, detailed essays and short definitions. Numerous figures and tables enhance understanding of this little-understood topic. Solidly structured and inclusive, this two-volume reference is an invaluable tool for clinical scientists and practitioners in academia, health care and industry, as well as students, teachers and interested laypersons. |
| define double blind study: 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. |
| define double blind study: 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. |
| define double blind study: 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 |
| define double blind study: The Management of Clinical Trials Hesham Abdeldayem, 2018-06-06 This concise book is addressed to researchers, clinical investigators, as well as practicing physicians and surgeons who are interested in the fields of clinical research and trials. It covers some important topics related to clinical trials including an introduction to clinical trials, some aspects concerning clinical trials in pediatric age group, and the unique aspects of the design of clinical trials on stem cell therapy. |
| define double blind study: 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. |
| define double blind study: 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. |
| define double blind study: 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. |
| define double blind study: Handbook of Statistics in Clinical Oncology John Crowley, Antje Hoering, Donna Ankerst, 2005-12-01 A compendium of cutting-edge statistical approaches to solving problems in clinical oncology, Handbook of Statistics in Clinical Oncology, Second Edition focuses on clinical trials in phases I, II, and III, proteomic and genomic studies, complementary outcomes and exploratory methods. Cancer Forum called the first edition a |
| define double blind study: State of Fear Michael Crichton, 2009-10-13 New York Times bestselling author Michael Crichton delivers another action-packed techo-thriller in State of Fear. When a group of eco-terrorists engage in a global conspiracy to generate weather-related natural disasters, its up to environmental lawyer Peter Evans and his team to uncover the subterfuge. From Tokyo to Los Angeles, from Antarctica to the Solomon Islands, Michael Crichton mixes cutting edge science and action-packed adventure, leading readers on an edge-of-your-seat ride while offering up a thought-provoking commentary on the issue of global warming. A deftly-crafted novel, in true Crichton style, State of Fear is an exciting, stunning tale that not only entertains and educates, but will make you think. |
| define double blind study: A Companion to Western Historical Thought Lloyd Kramer, Sarah Maza, 2008-04-15 This broad survey introduces readers to the major themes, figures,traditions and theories in Western historical thought, tracing itsevolution from biblical times to the present. Surveys the evolution of historical thought in the WesternWorld from biblical times to the present day. Provides students with the background to contemporaryhistorical debates and approaches. Serves as a useful reference for researchers andteachers. Includes chapters by 24 leading historians. |
| define double blind study: 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 |
| define double blind study: ClinicalTrials Curtis L. Meinert, 2012-03-27 The classic, definitive guide to the design, conduct, and analysis of randomized clinical trials. |
| define double blind study: 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. |
| define double blind study: Severe Asthma Kian Fan Chung, Elliot Israel, Peter G. Gibson, 2019-06-01 Severe asthma is a form of asthma that responds poorly to currently available medication, and its patients represent those with greatest unmet needs. In the last 10 years, substantial progress has been made in terms of understanding some of the mechanisms that drive severe asthma; there have also been concomitant advances in the recognition of specific molecular phenotypes. This ERS Monograph covers all aspects of severe asthma – epidemiology, diagnosis, mechanisms, treatment and management – but has a particular focus on recent understanding of mechanistic heterogeneity based on an analytic approach using various ‘omics platforms applied to clinically well-defined asthma cohorts. How these advances have led to improved management targets is also emphasised. This book brings together the clinical and scientific expertise of those from around the world who are collaborating to solve the problem of severe asthma. |
| define double blind study: The Invisible Gorilla Christopher Chabris, Daniel Simons, 2011-06-07 Reading this book will make you less sure of yourself—and that’s a good thing. In The Invisible Gorilla, Christopher Chabris and Daniel Simons, creators of one of psychology’s most famous experiments, use remarkable stories and counterintuitive scientific findings to demonstrate an important truth: Our minds don’t work the way we think they do. We think we see ourselves and the world as they really are, but we’re actually missing a whole lot. Chabris and Simons combine the work of other researchers with their own findings on attention, perception, memory, and reasoning to reveal how faulty intuitions often get us into trouble. In the process, they explain: • Why a company would spend billions to launch a product that its own analysts know will fail • How a police officer could run right past a brutal assault without seeing it • Why award-winning movies are full of editing mistakes • What criminals have in common with chess masters • Why measles and other childhood diseases are making a comeback • Why money managers could learn a lot from weather forecasters Again and again, we think we experience and understand the world as it is, but our thoughts are beset by everyday illusions. We write traffic laws and build criminal cases on the assumption that people will notice when something unusual happens right in front of them. We’re sure we know where we were on 9/11, falsely believing that vivid memories are seared into our minds with perfect fidelity. And as a society, we spend billions on devices to train our brains because we’re continually tempted by the lure of quick fixes and effortless self-improvement. The Invisible Gorilla reveals the myriad ways that our intuitions can deceive us, but it’s much more than a catalog of human failings. Chabris and Simons explain why we succumb to these everyday illusions and what we can do to inoculate ourselves against their effects. Ultimately, the book provides a kind of x-ray vision into our own minds, making it possible to pierce the veil of illusions that clouds our thoughts and to think clearly for perhaps the first time. |
| define double blind study: Reproducibility and Replicability in Science National Academies of Sciences, Engineering, and Medicine, Policy and Global Affairs, Committee on Science, Engineering, Medicine, and Public Policy, Board on Research Data and Information, Division on Engineering and Physical Sciences, Committee on Applied and Theoretical Statistics, Board on Mathematical Sciences and Analytics, Division on Earth and Life Studies, Nuclear and Radiation Studies Board, Division of Behavioral and Social Sciences and Education, Committee on National Statistics, Board on Behavioral, Cognitive, and Sensory Sciences, Committee on Reproducibility and Replicability in Science, 2019-10-20 One of the pathways by which the scientific community confirms the validity of a new scientific discovery is by repeating the research that produced it. When a scientific effort fails to independently confirm the computations or results of a previous study, some fear that it may be a symptom of a lack of rigor in science, while others argue that such an observed inconsistency can be an important precursor to new discovery. Concerns about reproducibility and replicability have been expressed in both scientific and popular media. As these concerns came to light, Congress requested that the National Academies of Sciences, Engineering, and Medicine conduct a study to assess the extent of issues related to reproducibility and replicability and to offer recommendations for improving rigor and transparency in scientific research. Reproducibility and Replicability in Science defines reproducibility and replicability and examines the factors that may lead to non-reproducibility and non-replicability in research. Unlike the typical expectation of reproducibility between two computations, expectations about replicability are more nuanced, and in some cases a lack of replicability can aid the process of scientific discovery. This report provides recommendations to researchers, academic institutions, journals, and funders on steps they can take to improve reproducibility and replicability in science. |
| define double blind study: 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. |
| define double blind study: The Powerful Placebo Arthur K. Shapiro, Elaine Shapiro, 2000-10-17 Ranging from antiquity to modern times, this history of the placebo effect is especially timely in light of renewed interest in the mind-body relationship. Until this century, most medications prescribed by physicians were pharmacologically inert, if not harmful. That is, physicians were prescribing placebos or worse without knowing it. In a sense, then, the history of medical treatment until relatively recently is the history of the placebo effect. Based on the authors' lifelong study and clinical research, this is a comprehensive and scholarly examination of the placebo effect. The authors begin by surveying the use of placebos from antiquity to modern times. They also examine the development, use, and validity of the double-blind, controlled clinical trial. And they present their own study of the placebo effect in more than 1000 patients. Demonstrating both the magnitude and the limitations of the placebo effect, the book helps to clarify knotty issues ranging from the evaluation of therapies to the ethics of conducting controlled studies in which patients are deliberately given placebos. With the renewed interest in the mind-body relationship as well as in the role of placebos in new and alternative medical procedures and therapies, the findings of this book are especially timely. |
DEFINE Definition & Meaning - Merriam-Webster
The meaning of DEFINE is to determine or identify the essential qualities or meaning of. How to use define in a sentence.
DEFINE Definition & Meaning | Dictionary.com
Define definition: to state or set forth the meaning of (a word, phrase, etc.).. See examples of DEFINE used in a sentence.
DEFINE | English meaning - Cambridge Dictionary
DEFINE definition: 1. to say what the meaning of something, especially a word, is: 2. to explain and describe the…. Learn more.
DEFINE definition and meaning | Collins English Dictionary
If you define something, you show, describe, or state clearly what it is and what its limits are, or what it is like. We were unable to define what exactly was wrong with him. [ VERB wh ]
Define - definition of define by The Free Dictionary
define - show the form or outline of; "The tree was clearly defined by the light"; "The camera could define the smallest object"
DEFINE - Definition & Meaning - Reverso English Dictionary
Define definition: state the meaning of a word or phrase. Check meanings, examples, usage tips, pronunciation, domains, related words.
define - Wiktionary, the free dictionary
May 13, 2025 · define (third-person singular simple present defines, present participle defining, simple past and past participle defined) To determine with precision; to mark out with …
Define: Definition, Meaning, and Examples - usdictionary.com
Dec 24, 2024 · The word "define" means to explain or clarify the meaning of something or to establish boundaries and parameters. It is a versatile word used in many contexts, from …
Define Definition & Meaning - YourDictionary
Define Sentence Examples The child's eagerness and interest carry her over many obstacles that would be our undoing if we stopped to define and explain everything. It will not be welfare (or, …
DEFINITION Definition & Meaning - Merriam-Webster
The meaning of DEFINITION is a statement of the meaning of a word or word group or a sign or symbol. How to use definition in a sentence.
A 12 WEEK RANDOMIZED, DOUBLE-BLIND, DOUBLE …
the study. The protocol is being updated to allow prior (single) TNF experience after appropriate washout irrespective of inadequate response or due to lack of continued access. Section 4.4.1 …
Science Unit 1 Study Guide: What is Science, Scientific …
Science Unit 1 Study Guide: What is Science, Scientific Method, Science Safety, and Tools Variables: Science Tools: only the materials that Listen and wear Keep y Keep your …
STU-SOP-DMS-002– Standard Operating Procedure on …
The trial protocol must define the level of blinding (e.g. single blind or double blind) and the process to manage emergency unblinding. Measures should be agreed during the design …
Double-Blind Controlled Experiments and the Orgone …
Wilhelm Reich never used double-blind controlled experimentation. The treatment protocol was virtually unknown at the time of his experimental work with orgone energy. Double-blind only …
Understanding a Cancer Research Study - Perelman School of …
A study can be blinded (i.e. single blinding) by allowing the provider to know who is getting the experimental drug but the patient does not know what they are getting. Double-blind studies …
Methodological standards for the conduct of new Cochrane …
considered. Some labels commonly used to define study designs can be ambiguous. For example a "double blind" study may not make it clear who is blind; a "case control" study may be …
Protocol Number (c ) J1B-MC-FRCF A Multicenter, …
Jun 10, 2020 · A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Crossover Study to ... Study to Evaluate the Efficacy and Safety of LY3454738 in Adults with Chronic ...
Integrity Check for the Dialysis Access Consortium (DAC) …
The DAC Graft Trial is a randomized, double-blind, placebo-controlled trial conducted at thirteen U.S. centers [1]. A major cause of complications in patients undergoing hemodialysis is …
A PHASE 2B/3 RANDOMIZED, DOUBLE-BLIND, PLACEBO …
The Protocol Summary reflects the testing procedure overall for the study and Section 9.2.1 and new Sections 9.2.1.1, 9.2.1.2, and 9.2.1.3 detail the testing procedures used for the overall …
A PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO …
a phase 3 randomized, double-blind, placebo-controlled, parallel group, multi-center study to evaluate the efficacy and safety of pf-04965842 monotherapy in subjects aged 12 years and …
Janssen Vaccines & Prevention B.V.* Clinical Protocol …
A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Assess the Efficacy and Safety of Ad26.COV2.S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults …
Randomized Controlled Trials (Experimental Studies)
information bias, is also controlled by a double-blinded study. Study subjects who are aware of their treatment status may differentially report symptoms or side effects. ... Inability to blind the …
Efficacy and Safety of Peppermint Oil in a Randomized, …
Study Design, Setting, and Patients The PEppeRmint Oil for the treatment of Irritable Bowel Syndrome: optimizing therapeUtic strAtegies using targeted DElivery (PERSUADE) study was …
Open Access Protocol EFFECT of daily antiseptic body wash …
Thus, a large study is needed to define the role of body wash with octenidine compared with placebo. MEthods And AnAlysIs study design EFFECT is a controlled, cluster-randomised, …
Opioid Postmarketing Requirements Consortium Study 3033-11
Apr 19, 2023 · A Randomized, Double-Blind, Placebo-Controlled, Clinical Trial of Structured Opioid Discontinuation versus Continued Opioid Therapy in Suboptimal and Optimal …
Ensuring a Blind Review - The University of Chicago Press: …
ENSURING A BLIND REVIEW Journal of the Society for Social Work and Research 3 Rev. 7/1/2013 “Although participation was limited to one mother-adolescent pair from a family, our …
T E ST I N G D R U G S in People - National University of …
the conduct of a study or the inter-p r etation of its results. Single-blind-ing consists of keeping patients fro m knowing whether they are re c e i v i n g the investigational drug or a placebo. In …
Prospective randomized clinical trial evaluating the impact of …
prepared for the study duration in 500 mL brown glass bottles and color-coded to maintain a double-blind study. Neither the participants nor the researchers were aware of group …
Curcumin and proton pump inhibitors for functional …
study aimed to compare the efficacy of curcumin with a PPI in the treatment of patients with functional dyspepsia. Methods Study design This multicentre, randomised, double blind, …
STATISTICAL R EVIEW AND EVALUATION - U.S. Food and …
Oct 5, 2011 · The primary efficacy objective of the 6-week double-blind phase of the study was to assess the efficacy of 2 dose levels of risperidone in the treatment of irritability and related …
SDTM Implementation Guide – Clear as Mud: Strategies for …
how can one report in standard domains using different study models (Double Blind vs. Open Label, Phase 1 vs. Phase 4, etc.). The more one gains experience with SDTM the more …
Diastat (diazepam) gel
A randomized, double-blind study compared sequential doses of diazepam rectal gel and placebo in 91 patients (47 children, 44 adults) exhibiting the appropriate seizure profile. The first dose …
The Foundations of Real Numbers: An Axiomatic Approach …
Page|30 AFRICAN DIASPORA JOURNAL OF MATHEMATICS ISSN: 1539-854X UGC CARE GROUP I(Double-Blind Peer Reviewed Refereed Open Access International e-Journal) https ...
Good Review Practice: Clinical Review of Investigational …
1 An investigational drug is defined as any drug or biologic that is used in a study or clinical trial. For the purposes of this document, all references to drugs include both human drugs and ...
Chapter 5 - Blind Peer Review by Academic Journals
Within the category of blind peer reviewing, a further distinction is drawn between single-blind and double-blind peer review. In single-blind review, the reviewer knows the identity of the author, …
STRUCTURE AND CONTENT OF CLINICAL STUDY REPORTS
provide a clear explanation of how the critical design features of the study were chosen and enough information on the plan, methods and conduct of the study so that there is no …
Statistical Analysis Plan - ClinicalTrials.gov
completion of the Double-Blind (DB) Treatment Period; 2) the final database lock after the completion of the Open-Label Extension (OLE) Period. The plan will be ... Study day will be …
A Randomized, Double-Blind, Placebo-Controlled …
in this double-blind, double-dummy, randomized, placebo-controlled, parallel- group study. The ethics committee at each institution approved the protocol and informed consent form. The first …
The New England Journal of Medicine
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24-month intervention with a specific multinutrient in people …
controlled, double-blind, parallel-group, multicentre trial done in 11 study sites in Finland, Germany, the Netherlands, and Sweden (appendix) with one to four optional, 12-month, …
CENTER FOR DRUG EVALUATION AND RESEARCH
Trilaciclib efficacy was investigated in Study G1T28-05, a randomized, double-blind, placebo-controlled, multicenter, Phase 2 study of the efficacy and safety of trilaciclib versus placebo …
Document Type: Clinical Study Protocol Official Title: A …
A randomized, double-blind, placebo-controlled, parallel-group, multicenter, event driven Phase III study to investigate the efficacy and safety of finerenone on the reduction of cardiovascular …
Efficacy and Safety of a Novel Botulinum Toxin A for Masseter …
Masseter Reduction: A Randomized, Double-Blind, Placebo-Controlled, Optimal Dose-Finding Study Ji Yeon Hong, MD, PhD, Guk Jin Jeong, MD, Tae-Rin Kwon, PhD, Jong Hwan Kim, …
A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR …
A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO CONTROLLED, SINGLE- AND MULTIPLE-DOSE ESCALATION STUDY TO EVALUATE THE SAFETY, …
Theroleofdeliberatepractice in expert performance: revisiting …
with notable exceptions, namely (i) employing a double-blind procedure, (ii) conducting analyses better suited to the study design, and (iii) testing previously unanswered questions about …
Benefit–risk assessment of vitamin D supplementation
Introduction This study assessed the benefit of higher-dose and higher achieved 25-hydroxyvitamin D levels [25(OH) D] versus any associated risk. Methods and results Based on …
Section 1.3, Data Collection and Experimental Design
A variable is any characteristic that is recorded for subjects in a study. For example, \gender," \major," \age," and \GPA" might be variables for a study about college students. 1 Designing a …
Experimental Epidemiology - JU Medicine
study design. •Placebos were first used in 1863 •The idea of randomization was introduced in 1923. •The first trial using properly randomized treatment and control groups also featured …
Randomisiert. Kontrolliert. Doppelblind. Warum? - swissethics
patients and the doctor in charge of the study. The most important instruments for avoiding these various forms of bias consist in the introduction of control, randomisation and blinding of the …
Randomized Controlled Trials - CHEST
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Ivosidenib for advanced IDH1-mutant cholangiocarcinoma
a multicentre, randomised, double-blind, placebo-controlled, phase 3 study. Lancet Oncol 2020; 21: 796–807. 2 Vogel A, Sahai V, Hollebecque A, et al. FIGHT-202: a phase II study of …
Minocycline in active rheumatoid arthritis - Wiley Online Library
Study design. The study was set up as a 26-week prospective, double-blind, placebo-controlled trial. After informed consent, the patients were randomly allocated to receive minocycline or …
Safety of Anacetrapib in Patients with or at High Risk for …
We conducted a randomized, double-blind, placebo-controlled trial to assess the ef- ficacy and safety profile of anacetrapib in patients with coronary heart disease or at high risk for coronary ...
PHASE I/II CLINICAL TRIAL DESIGN AND DOSE FINDING …
Discussions should happen before breaking blind After the design is finalized ... Suppose study A is designed with placebo, 20 mg, 40 mg, and 80 mg Study B with placebo, 0.1 mg, 1 mg, and …
Cognitive decline in the elderly: A double-blind, placebo
Study design GER.M.I.S. was conducted in the 23 centers over the same time-period following a double blind controlled design, BC-PSvs placebo. Pa tients were assigned to drug or placebo …
Chapter 3: Ethics and Study Design - HHS.gov
define it to be any study that requires IRB approval. These include: a. Data from living individuals b. Biological material from living individuals ... “The X-rays were read blind.” Double blinding is …
ความรู้พื้นฐาน …
การวิจัยทางคลีนิกทําอย่างไร? “มาตรฐานทองคํา”ในการวิจัยคือการสุ่มและควบคุม
Efruxifermin in Compensated Cirrhosis due to NASH/MASH: …
Results from a Randomized, Double-blind, Placebo-controlled, Phase 2b Trial (SYMMETRY) Stephen Harrison, MD, COL (Ret.), FAASLD. Dr Stephen A. Harrison, ... received at least one …
Double-blind, randomized, controlled, pilot study comparing …
Conclusions: In this first-ever, double-blind, randomized, placebo-controlled pilot study comparing Ayurveda, MTX, and their combi-nation,all 3 treatmentswere …
