By Phillip I. Good
This attractive and non-technical advisor to medical trials covers matters learn layout, association, administration, research, recruitment, reporting, software program, and tracking. unfastened from the jargon-laden remedy of alternative books, A Manager’s advisor to the layout and behavior medical Trials is outfitted upon the formulation of first making plans, then imposing, and eventually acting crucial assessments. bargains an government point presentation of managerial guidance as good as convenient checklists followed via extracts from submitted protocols comprises checklists, examples, and counsel, in addition to an invaluable appendix on to be had software program Covers e-submissions and use of desktops for direct information acquisition comprises funny but instructive and precise 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)
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.
Whether you will utilize an intent-to-treat protocol. • Degree of conﬁdence you wish to have in the ﬁnal results. • Sample size required. Be aware of regulatory requirements. asp. Put your major effort into Don’t collect data you don’t need preparing for the trials, not in Store and analyze the data you repairing them. Prepare for do collect exceptions. See Chapter 7. DO Steps C—F can be executed in parallel. C. Obtain Regulatory Agency Approval for the Trials. Obtaining regulatory agency approval can be as simple as submitting a written copy of the protocol you already developed.
Time scale in weeks. ” A less precise statement, such as “exclude those with severe hypertension” is not adequate and would be a future source of confusion. Though your ultimate decision must, of necessity, be somewhat arbitrary, remember that a study may always be viewed as one of a series. Though it may not be possible to reach a ﬁnal conclusion (at least one acceptable to the regulatory agency) until all the data are in, there may be sufﬁcient evidence at an earlier stage to launch a second broader set of trials before the ﬁrst set has ended.
A Manager's Guide to the Design and Conduct of Clinical Trials (Manager's Guide Series) by Phillip I. Good