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A systematic approach to all aspects of designing and conducting clinical trials The success or failure of clinical trials hinges on hundreds of details that need to be developed, often under less than ideal conditions. Written by one of the world's leading trialists, Clinical Trials Handbook: Design and Conduct provides clinicians with a complete guide to designing, conducting, and evaluating clinical trials—teaching them how to simplify the process and avoid costly mistakes. The author draws on his extensive clinical trials experience to outline all steps employed in setting up and running clinical trials, from budgeting and fundraising to publishing the results. Along the way, practical advice is offered while also addressing a mix of logistical, ethical, psychological, behavioral, and administrative issues inherent to clinical trials. Topics of coverage include: Protocols for drug masking, controls, and treatment randomization Consent, enrollment, eligibility, and follow-up procedures Different types of sample size design and data collection and processing Working with study centers, research staff, and various committees Monitoring treatment effects and performance, and ensuring quality control Data analysis and access policies for study data and documents Clinical Trials Handbook is invaluable for practicing clinicians and trialists who would like to learn more about or improve their understanding of the design and execution of clinical trials. The book is also an excellent supplement for courses on clinical trials at the graduate level.

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Clinical Trials Handbook. Design and Conduct

A thoroughly updated new edition of the essential reference on the design, practice, and analysis of clinical trials Clinical Trials Dictionary: Terminology and Usage Recommendations, Second Edition presents clear, precise, meticulously detailed entries on all aspects of modern-day clinical trials. Written and compiled by one of the world’s leading clinical trialists, this comprehensive volume incorporates areas of medicine, statistics, epidemiology, computer science, and bioethics—providing a treasure trove of key terms and ideas. This new edition continues to supply readers with the A–Z terminology needed to design, conduct, and analyze trials, introducing a vocabulary for the characterization and description of related features and activities. More than 300 new entries are now included, reflecting the current usage practices and conventions in the field, along with usage notes with recommendations on when to use the term in question. Detailed biographical notes highlight prominent historical figures and institutions in the field, and an extensive bibliography has been updated to provide readers with additional resources for further study. The most up-to-date work of its kind, Clinical Trials Dictionary, Second Edition is an essential reference for anyone who needs to report on, index, analyze, or assess the scientific strength and validity of clinical trials.

Curtis L. Meinert