Download A Manager's Guide to the Design and Conduct of Clinical by Phillip I. Good PDF

By Phillip I. Good

ISBN-10: 0471226157

ISBN-13: 9780471226154

ISBN-10: 0471461148

ISBN-13: 9780471461142

This enticing and non-technical advisor to medical trials covers matters research layout, association, administration, research, recruitment, reporting, software program, and tracking. loose from the jargon-laden remedy of alternative books, A Manager’s consultant to the layout and behavior medical Trials is equipped upon the formulation of first making plans, then enforcing, and eventually appearing crucial exams. bargains an government point presentation of managerial instructions as good as convenient checklists observed via extracts from submitted protocols contains checklists, examples, and suggestions, in addition to an invaluable appendix on to be had software program Covers e-submissions and use of desktops for direct info acquisition contains 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)

Example text

When will the measurements be made? How will the measurements be made? Who will make them? What units will be used? Who will interpret the measurements? What quantitative results do you expect? You must test for safety. What short-term side effects are expected? How do you plan to measure them? What quantitative results do you expect? How soon can you expect to observe them? What long-term side effects are expected? How do you plan to measure them? What quantitative results do you expect per 100 patients?

PRE-DESIGN CHECKLIST Before you can begin full-scale clinical trials, you need to establish: • • • • Mutagenicity, carcinogenicity, and toxicity in animals Mechanism of action in humans Maximum tolerated dose Minimum effective dose CHAPTER 5 DESIGN DECISIONS 29 We deal in Chapter 7 with the large number of minor details that must be thought through before we can conclude our preparations. SHOULD THE STUDY BE PERFORMED? We should always hesitate to undertake extensive trials when a surgical procedure is still in the experimental stages, or when the crosseffects with other commonly used drugs are not well understood.

I don’t recommend the hiring of “design” experts unless they are experts at facilitating group discussions. Those who will reap are those who must sow. ” To be effective, the members of the design team must be matched to the required skill sets that we cover at length below. These individuals include the following: The project manager whose chief skill is that of a facilitator, possessing the ability to draw out and motivate others, encourage differing points of view yet obtain consensus, assign and organize tasks, and make, not defer decisions.

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A Manager's Guide to the Design and Conduct of Clinical Trials (Manager's Guide Series) by Phillip I. Good

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