By Phillip I. Good
Chapter 1 lower charges and raise gains (pages 1–8):
Chapter 2 instructions (pages 9–14):
Chapter three Prescription for Sucess (pages 15–18):
Chapter four Staffing for fulfillment (pages 19–28):
Chapter five layout judgements (pages 29–46):
Chapter 6 Trial layout (pages 47–54):
Chapter 7 Exception dealing with (pages 65–72):
Chapter eight Documentation (pages 73–94):
Chapter nine Recruiting and holding Physicians and sufferers (pages 95–108):
Chapter 10 Computer?Assisted facts access (pages 109–124):
Chapter eleven information administration (pages 125–140):
Chapter 12 Are you prepared? (pages 141–144):
Chapter thirteen tracking the pains (pages 145–154):
Chapter 14 coping with the pains (pages 155–164):
Chapter 15 facts research (pages 165–198):
Chapter sixteen payment (pages 199–208):
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Extra info for A Manager's Guide to the Design and Conduct of Clinical Trials
They also will be expected to provide assistance and perhaps some direction in recruiting investigators for the study. The medical monitors will answer all questions from investigators as to the procedures to be followed and will investigate possible protocol violations. D. 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.
Again, we still need to define what we mean by “effective” and to list some if not all of the side effects we hope to diminish or eliminate. 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.
How likely are these patients to comply? Keep the experimental design simple (see Chapter 6). Keep the data collected to a minimum. Pretest all questionnaires to detect ambiguities. Use computer-assisted data entry to catch and correct data entry errors as they are made (see Chapter 10). Ensure the integrity and security of the stored data (see Chapter 11). Prepare a highly detailed procedures manual for the investigators and investigational laboratories to ensure uniformity in treatment and in measurement.