Read e-book online A Manager's Guide to the Design and Conduct of Clinical PDF

By Phillip I. Good

ISBN-10: 0471226157

ISBN-13: 9780471226154

ISBN-10: 0471461148

ISBN-13: 9780471461142

This attractive and non-technical advisor to medical trials covers concerns learn layout, association, administration, research, recruitment, reporting, software program, and tracking. unfastened from the jargon-laden therapy of different books, A Manager’s consultant to the layout and behavior medical Trials is outfitted upon the formulation of first making plans, then imposing, and eventually acting crucial exams. bargains an government point presentation of managerial instructions as good as convenient checklists followed by way of extracts from submitted protocols contains checklists, examples, and tips, in addition to an invaluable appendix on on hand software program Covers e-submissions and use of desktops for direct information 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)

Sample text

Multiple trials might be the maximum tolerable dose and the preferable in the following anticipated minimum effective dose. 10 • Monotherapy in one trial, STUDY OBJECTIVES I’m constantly amazed by the number of studies that proceed well into the clinical phase without any clear-cut statement of objectives. The executive committee has decreed “the intervention be taken to 10 See Fazzari, Heller, and Scher (2000). 30 PART I PLAN • combination therapy in another Different control groups for one-on-one comparisons for different benefits The trials need not be concurrent and can often benefit from the results of other trials in their final design.

3. 4. 5. 6. 7. 8. 9. 10. patient will receive injections for three days, self-administer a drug for six months, and attend first semiweekly and then weekly counseling sessions over the same period. 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).

Unplanned Closure A major advantage of computer-assisted direct data entry is that it facilitates monitoring the results to obtain early indications of the success or failure of the drug or device that is under test. ) 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.

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A Manager's Guide to the Design and Conduct of Clinical Trials (Manager's Guide Series) by Phillip I. Good


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