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By Phillip I. Good

This attractive and non-technical consultant to medical trials covers concerns learn layout, association, administration, research, recruitment, reporting, software program, and tracking. loose from the jargon-laden therapy of alternative books, A Manager’s consultant to the layout and behavior medical Trials is outfitted upon the formulation of first making plans, then enforcing, and at last appearing crucial tests. bargains an government point presentation of managerial guidance as good as convenient checklists observed through extracts from submitted protocols contains checklists, examples, and tips, in addition to an invaluable appendix on on hand software program Covers e-submissions and use of desktops for direct facts acquisition accommodates funny but instructive and real anecdotes to illustrate universal pitfalls

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Extra info for A Manager's Guide to the Design and Conduct of Clinical Trials (Manager's Guide Series)

Sample text

If you’re that manager’s manager or, more aptly, the executive who dreamed up this absurd head-count policy, do your company and your own stock options a favor: resign. 9 Don’t attribute this quote to me, Professor Deming and the pioneer industrial engineers of the 1920s said it long before. ” A clinical trial necessitates a large financial investment. Once we launch the trials, we can plan on tying up both our investment and the work product of several dozen individuals for at least the next two to six years.

Keep the intervention simple. I am currently serving as a statistician on a set of trials where, over my loudest protests, each 36 PART I PLAN 2. 3. 4. 5. 6. 7. 8. 9. 10. patient will receive injections for three days, self-administer a drug for six months, and attend first semiweekly and then weekly counseling sessions over the same period. How likely are these patients to comply? Keep the experimental design simple (see Chapter 6). Keep the data collected to a minimum. Pretest all questionnaires to detect ambiguities.

5 See Chapter 15 for a comprehensive description of these duties. 6 See, for example, the section on determining sample size in Chapter 6. 7 See, for example, the bibliography at the end of Chapter 5. 20 PART I PLAN liaison’s formal “role” is to interact with the regulatory agency, assuming (or, more accurately, sharing) the responsibility of interpreting the applicable regulations and ensuring the trials remain in compliance. A marketing representative can provide valuable input on desirable end points (you can’t claim what you haven’t established) and can aid in making the initial decision as to whether the trials are justified.

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