Resource title

Responder Identification in Clinical Trials with Censored Data

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Resource description

We present a newly developed technique for identification of positive and negative responders to a new treatment which was compared to a classical treatment (or placebo) in a randomized clinical trial. This bump-hunting-based method was developed for trials in which the two treatment arms do not differ in survival overall. It checks in a systematic manner if certain subgroups, described by predictive factors do show difference in survival due to the new treatment. Several versions of the method were discussed and compared in a simulation study. The best version of the responder identification method employs martingale residuals to a prognostic model as response in a stabilized through bootstrapping bump hunting procedure. On average it recognizes 90% of the time the correct positive responder group and 99% of the time the correct negative responder group.

Resource author

Victoria Kehl, Kurt Ulm

Resource publisher

Resource publish date

Resource language

eng

Resource content type

text/html

Resource resource URL

http://hdl.handle.net/10419/23869

Resource license

Adapt according to the presented license agreement and reference the original author.