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Informationen zum Autor CURTIS L. MEINERT, PhD, is Professor in the Departments of Epidemiology and Biostatistics at the Johns Hopkins Bloomberg School of Public Health, where he served as founder of the Johns Hopkins Center for Clinical Trials. He is a Fellow of the American College of Epidemiology, the American Association for the Advancement of Science, the American Heart Association, and the Society for Clinical Trials. Dr. Meinert has focused his research on the methodological issues in clinical trials, including their design, conduct, policy, and practice. He is the author of Clinical Trials Dictionary: Terminology and Usage Recommendations, Second Edition (Wiley). Klappentext A systematic approach to all aspects of designing and conducting clinical trialsThe 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 documentsClinical 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. "In summary, Clinical Trials Handbook is a user friendly book with numerous examples from the real clinical trials. It outlines all steps employed in setting up and running clinical trials, from budgeting and fundraising to publishing the results. It is an asset to 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." ( Journal of Biopharmaceutical Statistics , 1 April 2013) Zusammenfassung 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. Inhaltsverzeichnis Acknowledgments xi Preface xiii On planning xv Explanatory notes, focus, and conventions xvii Abbreviations and designations xxi I. General 1 1. Terminology 3 2. Definitions 5 3. Measurement units 7 4. Trial type 9 5. Design and flow schematics 13 6. Design and operating principles 15 7. Counting and analysis rules 17 8. Multi-study umbrella name 19 9. Study name 21 II. Design Specifications 25 10. Objective 27 11. Specific aims 29 12. Experimental variable 31 13. Treatment unit 33 14. Primary outcome 35 15. Outcome measures 39 16. Design synopsis 41 III. Funding 45 17. Type of funding initiative 47 <...
