By Phillip I. Good
This enticing and non-technical advisor to medical trials covers concerns examine layout, association, administration, research, recruitment, reporting, software program, and tracking. unfastened from the jargon-laden remedy of different books, A Manager’s consultant to the layout and behavior scientific Trials is equipped upon the formulation of first making plans, then enforcing, and at last appearing crucial tests. deals an govt point presentation of managerial guidance as good as convenient checklists followed by way of extracts from submitted protocols contains checklists, examples, and counsel, in addition to an invaluable appendix on to be had software program Covers e-submissions and use of pcs for direct facts acquisition contains funny but instructive and precise 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)
1994) have provided equally strong arguments against. Our own view is that a member of your staff should perform the initial monitoring but that modiﬁcation or termination of the trials should not take place until an independent panel has reviewed the ﬁndings. ) And you’ll still be obligated to track down each patient once all the data are in and analyzed in order for their physicians to give them a ﬁnal brieﬁng. By having all trials terminate on a ﬁxed date, you eliminate these disadvantages while gaining additional, if limited, information on long-term effects.
PRIMARY END POINTS Our next task is to determine the primary end points that will be used to assess efﬁcacy. Here are a few guidelines: • • • Objective criteria are always preferable to subjective. True end points such as death or incidence of strokes should be employed rather than surrogate response variables such as tumor size or blood pressure. The latter is only appropriate (though not always avoidable) during the early stages of clinical investigation when trials are of short duration. The fewer the end points the better.
They will not be working alone but in partnership with the clinical research monitors who bear the responsibility for the sequencing of questions and specifying the range of permissible answers. Programming sophistication is not as important as good interpersonal skills (particularly today when the software does so much of the detail work). As illustrated in Chapter 10, a knowledge of ergonomics is essential. The size of the team will depend on the time lines that have been established. At least one member of the software design team should be from the testing group to ensure that quality is built in from the start.
A Manager's Guide to the Design and Conduct of Clinical Trials (Manager's Guide Series) by Phillip I. Good