Biometric design of controlled clinical therapeutical studies .1. Fundamentals

被引：1
作者：
Mau, J
机构：
来源：
PHYSIKALISCHE MEDIZIN REHABILITATIONSMEDIZIN KURORTMEDIZIN | 1997年 / 7卷 / 02期
关键词：
randomisation; controlled clinical trial; comparative clinical study; Good Clinical Practice; trial protocol; study design; ethical aspects;
D O I：
10.1055/s-2008-1061863
中图分类号：
R49 [康复医学];
学科分类号：
100215 ;
摘要：
The process of preparing clinical studies for an evaluation of efficacy and tolerability of new therapeutical procedures may be divided into 5 phases; in the planning phase the focus is on the medical rationale and the design, the clinical protocol, statistical analysis and trial management. The legal side conditions are set by national laws for drug regulations and an EC-note for guidance on Good Clinical Practices, which contain many methodological recommendations that can usefully be applied in a context of non-drug therapies.
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页码：69 / 75
页数：7
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