By Phillip I. Good
This enticing and non-technical consultant to medical trials covers matters examine 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 scientific Trials is outfitted upon the formulation of first making plans, then enforcing, and at last acting crucial assessments. deals an government point presentation of managerial directions as good as convenient checklists observed through extracts from submitted protocols comprises checklists, examples, and assistance, in addition to an invaluable appendix on on hand software program Covers e-submissions and use of desktops for direct facts 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)
S. path to putting a man on the moon involved putting a Rhesus monkey into orbit. The monkey was watched and probed intently and studied from every angle. Evenings and weekends, in the absence of human observers, a dozen or more recorders kept track of the monkey’s temperature, blood pressure, and other vital readings. Only no one looked at the output. The monkey was in orbit before the earth-bound observers noticed he was running a fever. Yes, the monkey died. A typical set of clinical trials today costs what that wasted spaceshot did in the 1950s.
Procrastinators need not apply. Two physicians, one to concentrate on measures of efﬁcacy, the other on safety. Both should be specialists in the area under investigation. As the two are intended to provide differing and, sometimes, conﬂicting points of view, they cannot be in a mentor-student or a supervisor-employee relationship. Both will be expected to CHAPTER 4 STAFFING FOR SUCCESS 19 interpret ﬁnal results and sign off on reports to the regulatory agencies. 4 As discussed in the next chapter, they will be expected to provide assistance in determining what information is to be collected and how measurements are to be made and interpreted.
6 One or more clinical research monitors (CRMs) will serve, along with the Medical Monitor, as the principal points of contact with study investigators and their staff. They will participate in literally all phases of the study. Monitors must like to travel and be able to remain away from home for extended periods (they will have to remain in the ﬁeld for training and perhaps to see the ﬁrst several patients through the trial process at each site). They must have excellent communication skills and be able to maintain emotional as well as intellectual empathy with physicians and their assistants.