By Phillip I. Good
This attractive and non-technical advisor to scientific trials covers matters learn layout, association, administration, research, recruitment, reporting, software program, and tracking. loose from the jargon-laden remedy of different books, A Manager’s consultant to the layout and behavior medical Trials is outfitted upon the formulation of first making plans, then imposing, and eventually appearing crucial assessments. deals an government point presentation of managerial directions as good as convenient checklists followed by means of extracts from submitted protocols comprises checklists, examples, and tips, in addition to an invaluable appendix on on hand software program Covers e-submissions and use of pcs for direct facts acquisition contains funny but instructive and actual anecdotes to illustrate universal pitfalls
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Extra resources for A Manager's Guide to the Design and Conduct of Clinical Trials (Manager's Guide Series)
2000) uncovered the following ﬂaws: • Disparity between the reviewed records and the data presented at two international meetings • No signed informed consent • No record of approval for the investigational therapy • Control regimen not as described in the protocol Inspect the site where the drugs or devices are packaged; specify the allowable tolerances; repackage or relabel drugs at the pharmacy so that both the patient’s name and the code number appear on the label; draw random samples from the delivered formulations and have these samples tested for potency at intervals by an independent laboratory.
Simple, straightforward designs simplify training, encourage uniformity of execution, and are more likely to be adhered to in a uniform manner by your investigators. Keep your intervention simple—a pill a day is preferable to three or four if you want to ensure patient compliance. I hold little hope for a recently launched trial of a smoking cure which requires each subject to receive a preliminary three-day course of injections, take pills twice a day for 90 days, and attend weekly counseling sessions.
Start with your reports and package insert. Let them determine the data you’ll need. Specify primary measures of efﬁcacy. Decide what end points will be used to measure them. See Chapter 5. Specify all measures of safety and any secondary measures of efﬁcacy. Will you use checklists of adverse events at follow-up? Ask patients to volunteer concerns? Or do both? How long will the follow-up period be? See Chapter 5. CHAPTER 3 PRESCRIPTION FOR SUCCESS 15 Specify eligibility requirements. Too narrow a patent will force you to repeat the trials later and may make it difﬁcult to recruit the necessary number of subjects.
A Manager's Guide to the Design and Conduct of Clinical Trials (Manager's Guide Series) by Phillip I. Good