Responder Identification in Clinical Trials with Censored Data

Arbeitspapier

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.

Angaben zum Objekt

• Sprache: Englisch

Verweise und Beziehungen

• Erschienen in: Series: Discussion Paper ; No. 311

Klassifikation und Themen

• Thema: responder identification ; bump hunting ; predictive factors

Beteiligte, Orts- und Zeitangaben

• Ereignis: Geistige Schöpfung
• (wer): Kehl, Victoria ; Ulm, Kurt
• Ereignis: Veröffentlichung
• (wer): Ludwig-Maximilians-Universität München, Sonderforschungsbereich 386 - Statistische Analyse diskreter Strukturen
• (wo): München
• (wann): 2003

Weitere Informationen

• DOI: doi:10.5282/ubm/epub.1692
• Handle: http://hdl.handle.net/10419/23869
• URN: urn:nbn:de:bvb:19-epub-1692-3
• Letzte Aktualisierung: 10.03.2025, 11:43 MEZ