Adaptive designs for single-arm phase II trials in oncology

• Verfasst von: Englert, Stefan [VerfasserIn]
• Verfasst von: Kieser, Meinhard [VerfasserIn]
• Titel: Adaptive designs for single-arm phase II trials in oncology
• Verf.angabe: Stefan Englert and Meinhard Kieser
• E-Jahr: 2012
• Jahr: May/June 2012
• Umfang: 9 S.
• Fussnoten: Gesehen am 08.11.2018
• Titel Quelle: Enthalten in: Pharmaceutical statistics
• Ort Quelle: New York, NY : Wiley, 2002
• Jahr Quelle: 2012
• Band/Heft Quelle: 11(2012), 3, Seite 241-249
• ISSN Quelle: 1539-1612
• DOI: doi:10.1002/pst.541
• Datenträger: Online-Ressource
• Sprache: eng
• Sach-SW: adaptive design
• Sach-SW: clinical trial
• Sach-SW: discrete test statistics
• Sach-SW: phase II
• Sach-SW: two-stage design
• K10plus-PPN: 1582706514

Abstract

Clinical phase II trials in oncology are conducted to determine whether the activity of a new anticancer treatment is promising enough to merit further investigation. Two-stage designs are commonly used for this situation to allow for early termination. Designs proposed in the literature so far have the common drawback that the sample sizes for the two stages have to be specified in the protocol and have to be adhered to strictly during the course of the trial. As a consequence, designs that allow a higher extent of flexibility are desirable. In this article, we propose a new adaptive method that allows an arbitrary modification of the sample size of the second stage using the results of the interim analysis or external information while controlling the type I error rate. If the sample size is not changed during the trial, the proposed design shows very similar characteristics to the optimal two-stage design proposed by Chang et al. (Biometrics 1987; 43:865-874). However, the new design allows the use of mid-course information for the planning of the second stage, thus meeting practical requirements when performing clinical phase II trials in oncology. Copyright © 2012 John Wiley & Sons, Ltd.