By Phillip I. Good
This enticing and non-technical consultant to scientific trials covers matters research 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 outfitted upon the formulation of first making plans, then imposing, and eventually acting crucial assessments. bargains an govt point presentation of managerial directions as good as convenient checklists followed via extracts from submitted protocols comprises checklists, examples, and tips, in addition to an invaluable appendix on to be had software program Covers e-submissions and use of pcs for direct information acquisition comprises funny but instructive and real anecdotes to illustrate universal pitfalls
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Additional info for A Manager's Guide to the Design and Conduct of Clinical Trials (Manager's Guide Series)
Favalli et al. (2000) reviewed several dozen protocols looking for sources of inaccuracy. Problems in data management and a lack of clarity of the protocol and/or case 12 See Greene et al. (1992) for other possible decisions. 42 PART I PLAN report forms were the primary offenders. They pointed out that training and supervision of data managers, precision in writing protocols, standardization of the data entry process, and the use of a checklist for therapy data and treatment toxicities would have avoided many of these errors.
Financial Times, 10 September 2001 You could use your full-time employees to conduct the clinical trials, or you could hire, on a temporary basis, a few or all of the people you need. You could have a stafﬁng ﬁrm supply the programmers you need, and place an advertisement for a consulting statistician. You could even hire a contract research organization (CRO) that will design and conduct part or all of the trials for you. If you’re a struggling one-product startup with just enough working capital, the 26 PART I PLAN Whether you decide to hire fulltime employees, lease contract employees, or farm out the study to a contract research organization, you continue to bear the responsibility for the successful conduct and administration of the trials.
3. Will it be a single-blind or a double-blind study? 4. What sample size is necessary to detect the effect? 5. How many examination sites will we need? PRE-DESIGN CHECKLIST Before you can begin full-scale clinical trials, you need to establish: • • • • Mutagenicity, carcinogenicity, and toxicity in animals Mechanism of action in humans Maximum tolerated dose Minimum effective dose CHAPTER 5 DESIGN DECISIONS 29 We deal in Chapter 7 with the large number of minor details that must be thought through before we can conclude our preparations.
A Manager's Guide to the Design and Conduct of Clinical Trials (Manager's Guide Series) by Phillip I. Good