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Developing better methods of 'blinding' doctors and patients in clinical trials
October 31, 2006When trials are carried out to assess the effectiveness of a drug, it is an important to have a control group of patients who are not given the drug. Neither the researchers nor the patients should know who is in the treatment group and who is in the control group. In other words they should be 'blinded'. There are different ways in which this blinding can be achieved. French researchers carefully studied all the reports of drug trials that involved blinding, published in the course of one year. They have produced a classification of the methods used.
The findings of the review should lead to a better understanding of different blinding methods and their effectiveness. This will help researchers design better trials in the future, and also help readers interpret the quality of trials. The authors of the review also say that blinding methods are often not described in enough detail in published scientific papers. They recommend that guidelines for the reporting of trials are improved.
Public Library of Science
Clinical Trial Current Events and Clinical Trial News RSSVioxx trial data shows early cardiovascular risk
Evidence of cardiovascular risks associated with taking Vioxx, the popular, nonsteroidal anti-inflammatory drug (rofecoxib), could have been identified nearly four years before its manufacturer, Merck & Co. Inc., voluntarily pulled the drug from the market.
New cancer target for non-Hodgkin's lymphoma
Physician-scientists from Weill Cornell Medical College have discovered a molecular mechanism that may prove to be a powerful target for the treatment of non-Hodgkin's lymphoma, a type of cancer that affects lymphocytes, or white blood cells.
At-risk college students reduce HBP, anxiety, depression through Transcendental Meditation
The Transcendental Meditation technique may be an effective method to reduce blood pressure, anxiety, depression, and anger among at-risk college students, according to a new study to be published in the American Journal of Hypertension, December 2009.
Client-directed therapy technique drastically reduces divorce/separation rates
Using four simple questions to generate client-directed feedback can greatly increase the chances that struggling couples will stay together, according to a recently published study.
Researchers find potential treatment for Huntington's disease
Investigators at Burnham Institute for Medical Research (Burnham), the University of British Columbia's Centre for Molecular Medicine and Therapeutics and the University of California, San Diego have found that normal synaptic activity in nerve cells (the electrical activity in the brain that allows nerve cells to communicate with one another) protects the brain from the misfolded proteins associated with Huntington's disease.
New evidence that dark chocolate helps ease emotional stress
The "chocolate cure" for emotional stress is getting new support from a clinical trial published online in ACS' Journal of Proteome Research.
UT Southwestern aids national effort to recruit volunteers for medical research
A new national initiative involving UT Southwestern Medical Center will match volunteers who want to take part in medical research studies with the scientists who are leading those studies.
Treatment to improve degenerating muscle gains strength
A study appearing in Science Translational Medicine puts scientists one step closer to clinical trials to test a gene delivery strategy to improve muscle mass and function in patients with certain degenerative muscle disorders.
Researchers mobilizing global resources to test new treatments for severe H1N1 infection
An important, ground-breaking initiative is unfolding in the global critical care community in response to the H1N1 pandemic.
Mood improves on low-fat, but not low-carb, diet plan
After one year, a low-calorie, low-fat diet appears more beneficial to dieters' mood than a low-carbohydrate plan with the same number of calories.
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Clinical Trials - A Practical Guide to Design, Analysis, and Reporting by Duolao Wang (Author), Ameet Bakhai (Author) Clinical trials form the backbone of evidence-based medicine, and appreciating clinical trial methods allows readers to critique, design and report clinical trials. This book is a friendly 'jargon buster' which aims to demystify the subject. It is divided into five sections: fundamentals of trial design, alternative trial designs, basics of statistical analysis, special trial issues in data analysis, and reporting of trials. Using simple language, the book explains - with illustrations of numerous trial examples - the conceptual and methodological issues that occur at all stages of clinical trial covering trial design, conduct, analysis and reporting. The book is an educational and approachable reference in a difficult area of medicine where clinicians often... |
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Fundamentals of Clinical Trials by Lawrence M. Friedman (Author), Curt D. Furberg (Author), David L. DeMets (Author) This text is intended for the clinical researcher who is interested in designing a clinical trial and developing a protocol. It is also of value to researchers and practitioners who must critically evaluate the literature of published clinical trials and assess the merits of each trial and the implications for the care and treatment of patients. The text uses numerous examples of published clinical trials from a variety of medical disciplines to meaningfully illustrate the fundamentals. Technical design issues such as sample size are considered, but the technical details have been suppressed as much as possible through the use of graphs and tables. While the technical material has been kept to a minimum, the statistician may still find the principles and fundamentals presented in this... |
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Clinical Trials: A Methodologic Perspective Second Edition(Wiley Series in Probability and Statistics) by Steven Piantadosi (Author) Learn rigorous statistical methods to ensure valid clinical trials This Second Edition of the critically hailed Clinical Trials builds on the text's reputation as a straightforward and authoritative presentation of statistical methods for clinical trials. Readers are introduced to the fundamentals of design for various types of clinical trials and then skillfully guided through the complete process of planning the experiment, assembling a study cohort, assessing data, and reporting results. Throughout the process, the author alerts readers to problems that may arise during the course of the trial and provides commonsense solutions. The author bases the revisions and updates on his own classroom experience, as well as feedback from students, instructors, and... |
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A Manager's Guide to the Design and Conduct of Clinical Trials (Manager's Guide Series) by Phillip I. Good (Author) This newly updated edition of the benchmark guide to computer-assisted clinical trials provides a comprehensive primer for prospective managers. It covers every critical issue of the design and conduct of clinical trials, including study design, organization, regulatory agency liaison, data collection and analysis, as well as recruitment, software, monitoring, and reporting. Keeping the same user-friendly format as the original, this Second Edition features new examples and the latest developments in regulatory guidelines, such as e-submission procedures and computerized direct data acquisition. The new edition also reflects the increasing globalization of clinical trial activities, and includes new information about international standards and procedures, including the... |
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Conducting Clinical Research: A Practical Guide for Physicians, Nurses, Study Coordinators, and Investigators by Judy Stone (Author) In Conducting Clinical Research: A Practical Guide for Physicians, Nurses, Study Coordinators, and Investigators, you will discover how to Attract drug companies to your site Land a study on good terms Recruit patient volunteers --- and keep them happy! Implement easy strategies for coordinating studies Organize your clinical trial activities Demystify regulatory requirements
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A Concise Guide to Clinical Trials by Allan Hackshaw (Author) Clinical trials have revolutionized the way disease is prevented, detected and treated, and early death avoided, and they continue to be an expanding area of research. They are central to the work of pharmaceutical companies, and there are many academic and public sector organizations that conduct trials on a wide variety of interventions, including drugs, devices, surgical techniques, and changes in behaviour and lifestyle. A Concise Guide to Clinical Trials provides a comprehensive yet easy-to-read overview of the design, conduct and analysis of trials. It requires no prior knowledge on the subject as the important concepts are introduced throughout. There are chapters that distinguish between the different types of trials, and an introduction to systematic reviews,... |
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Textbook of Clinical Trials by David Machin (Editor), Simon Day (Editor), Sylvan Green (Editor) 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... |
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Principles and Practice of Clinical Trial Medicine by Richard Chin (Author), Bruce Y Lee (Author) 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, this book 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... |
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Clinical Trials: A Practical Approach by Stuart J. Pocock (Author) This comprehensive, unified text on the principles and practice of clinical trials presents a detailed account of how to conduct the trials. It describes the design, analysis, and interpretation of clinical trials in a non-technical manner and provides a general perspective on their historical development, current status, and future strategy. Features examples derived from the author's personal experience. |
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A Step-By-Step Guide to Clinical Trials by Marilyn Mulay (Author) Provides a practical approach to understanding the components of a clinical research trial as well as the tools to conduct a well- organized study. Designed for those interested in developing or enhancing skills to coordinate all aspects of clinical trials such as regulatory requirements, budgeting, contracts, patient recruitments and participation, and gathering and recording clear, invaluable data. |
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