By Phillip I. Good
This enticing and non-technical advisor to scientific trials covers concerns examine layout, association, administration, research, recruitment, reporting, software program, and tracking. unfastened from the jargon-laden therapy of different books, A Manager’s advisor to the layout and behavior scientific Trials is outfitted upon the formulation of first making plans, then imposing, and eventually appearing crucial tests. deals an govt point presentation of managerial directions as good as convenient checklists observed by means of extracts from submitted protocols comprises checklists, examples, and counsel, in addition to an invaluable appendix on on hand software program Covers e-submissions and use of pcs for direct facts acquisition comprises funny but instructive and real anecdotes to illustrate universal pitfalls
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Additional resources for A Manager's Guide to the Design and Conduct of Clinical Trials (Manager's Guide Series)
24 PART I PLAN The committees appointed to review and interpret angiograms, X rays, EEGs, and ECGs. should consist of experts in the speciﬁc diagnostic area. The assignment-of-cause committee would consist of specialists in the disease process. The trial modiﬁcation committee should include a statistician as well as physicians. All the committees should be able to call on additional experts—bioengineers, epidemiologists, geneticists, or pharmacologists—whenever they feel such services are warranted.
Do you and should you discontinue the trials? One school of thought favors that you continue the trials but modify your method of allocation to treatment. , 1990). Others would argue that continuing to deny the most effective treatment to any patient is unethical. The important thing is that you decide in advance of the trials the procedures you will follow should a situation like this arise. If you ﬁnd it is your product that appears to be causing the stomach cramps, you’ll want a thorough workup on each of the complaining patients.
Write and rewrite a patient manual to be given to each patient by their physician. Encourage and pay investigators to spend quality time with each patient. Other measures for reducing dropouts and ensuring patient compliance are discussed in Chapter 9. STUDY POPULATION Your next immediate question is how broad a patent to claim. That is, for what group of patients and for what disease conditions do you feel your intervention is appropriate? Too narrow a claim may force you to undertake a set of near duplicate trials at a later date.
A Manager's Guide to the Design and Conduct of Clinical Trials (Manager's Guide Series) by Phillip I. Good