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The new EMEA-CHMP guideline on clinical trials in small populations - methodological and statistical considerations with published examples

Gerß J., Köpcke W.

Biocybernetics and Biomedical Engineering

2007

Vol. 27, no. 3

59-66

The EMEA-CHMP guideline on clinical trials in small populations considers problems associated with clinical trials, when there are very few patients available to study. In such conditions, less conventional and/or less common methodological approaches may be acceptable. In the present report, selected strategies for approaches to trials in small populations are briefly outlined. It focuses on Chapter 6 of the guideline – Methodological and statistical considerations. Methods are addressed, that may increase the efficiency of the design or analysis of a trial where large studies are not feasible. In addition to general principles, specific examples of published studies are presented.