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

By Phillip I. Good

This enticing and non-technical advisor to medical trials covers concerns learn layout, association, administration, research, recruitment, reporting, software program, and tracking. loose from the jargon-laden therapy of different books, A Manager’s advisor to the layout and behavior scientific Trials is equipped upon the formulation of first making plans, then enforcing, and eventually appearing crucial exams. bargains an government point presentation of managerial guidance as good as convenient checklists followed via extracts from submitted protocols comprises checklists, examples, and information, in addition to an invaluable appendix on to be had software program Covers e-submissions and use of pcs for direct info acquisition comprises funny but instructive and real 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)

Sample text

As my passion for icecream reveals, I don’t really care about cholesterol at all, or at least I didn’t for most of my life. But I do not want to have a heart attack or a stroke and I’ve been told that if I keep my blood pressure down and my cholesterol levels low I may well avoid both. It is both less time-consuming and less expensive to measure changes in surrogate variables like cholesterol and blood pressure than it is to track survival. The former can be detected in days to weeks; the latter will (hopefully in my case) take many years.

Maintain a ledger of the human-hours and supplies expended on each phase of the project. B. Design the Trials. 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?

Tumors regress, Alzheimer’s patients become and stay coherent, and six recipients of your new analgesic get severe stomach cramps. You crack the treatment code and determine that the results favor one treatment over the other. Or, perhaps, that there is so little BEWARE OF HOLES IN THE INSTRUCTIONS The instructions for Bumbling Pharmaceutical’s latest set of trials seemed almost letter perfect. At least they were lengthy and complicated enough that they intimidated anyone who took the time to read them.

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