Checklist for the Planning, Implementation and Evaluation of Therapeutic Studies
The aim of this chapter is to draw up a checklist for the salient points to be considered during the design, implementation and evaluation of therapeutic studies. This checklist is intended to enable the doctors, scientists, and sponsoring institutions involved in these activities to examine a study proposal as to completeness. There will, of course, always be some therapeutic studies in which not all points mentioned in this checklist must be taken into account; however, even for such cases, the catalogue set out in the following may fulfil an important purpose: to remind all involved of the reasons why certain requirements of the checklist were disregarded. The aspects set out in Ch. 2.1., “Planning of Experiments” are relevant mainly for controlled clinical trials, whereas the principles formulated in the later sections remain valid for nearly all types of therapeutic studies.
KeywordsTime Schedule Therapeutic Study Sequential Plan Efficacy Criterion Documentation Form
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