This engaging and non--technical guide to clinical trials covers issues study design, organization, management, analysis, recruitment, reporting, software, and monitoring. Free from the jargon--laden treatment of other books, A Manager's Guide to the Design and Conduct Clinical Trials is built upon the formula of first planning, then implementing, and finally performing essential checks. Offers an executive level presentation of managerial guidelines as well as handy checklists accompanied by extracts from submitted protocols Includes checklists, examples, and tips, as well as a useful appendix on available software Covers e--submissions and use of computers for direct data acquisition Incorporates humorous yet instructive and true anecdotes to illustrate common pitfalls
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"...readable, informative and at times witty...never stops being concise and well written...a book worth a read..." (Statistics in Medicine, Vol 23(3), 15 February 2004) "The book is very prescriptive and full of lists and tables with which to guide managers in making effective decisions in using computer-assisted clinical trials in pharmaceutical studies." (Technometrics, Vol. 45, No. 1, February 2003) "This book is must-have reading for anyone in the business..." (Clinical Chemistry, Vol. 49, No. 7, 2003)
This engaging and non--technical guide to clinical trials covers issues study design, organization, management, analysis, recruitment, reporting, software, and monitoring. Free from the jargon--laden treatment of other books, A Manager's Guide to the Design and Conduct Clinical Trials is built upon the formula of first planning, then implementing, and finally performing essential checks. Offers an executive level presentation of managerial guidelines as well as handy checklists accompanied by extracts from submitted protocols Includes checklists, examples, and tips, as well as a useful appendix on available software Covers e--submissions and use of computers for direct data acquisition Incorporates humorous yet instructive and true anecdotes to illustrate common pitfalls
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