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Stat Med. 2014 Jul 30;33(17):2939-52. doi: 10.1002/sim.6155. Epub 2014 Mar 21.

On responder analyses in the framework of within subject comparisons - considerations and two case studies.

Author information

1
Bayer Pharma AG, Global Clinical Statistics, Berlin, Germany.

Abstract

A responder analysis is a common tool when clinical data are reported. In this paper, we extend the definition of responders to within subject comparisons and present a rigorous definition of the corresponding statistical functional. Via simulation studies, we get further insights under which conditions these analyses can even result in a higher power compared with an analysis based on the arithmetic mean. We report two case studies where these analyses contributed to a better understanding of the clinical data especially as some large observations were present that had a notable impact on the observed standard deviation.

KEYWORDS:

clinical trials; responder analysis; statistical functional; within subject comparison

PMID:
24652819
DOI:
10.1002/sim.6155
[Indexed for MEDLINE]
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