Bayesian adaptive bandit-based designs using the Gittins index for multi-armed trials with normally distributed endpoints

Adaptive designs for multi-armed clinical trials have become increasingly popular recently because of their potential to shorten development times and to increase patient response. However, developing response-adaptive designs that offer patient-benefit while ensuring the resulting trial provides a...

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Bibliographische Detailangaben
Veröffentlicht in:Journal of applied statistics. - 1991. - 45(2018), 6 vom: 12., Seite 1052-1076
1. Verfasser: Smith, Adam L (VerfasserIn)
Weitere Verfasser: Villar, Sofía S
Format: Online-Aufsatz
Sprache:English
Veröffentlicht: 2018
Zugriff auf das übergeordnete Werk:Journal of applied statistics
Schlagworte:Journal Article Gittins index Multi-armed bandit normally distributed endpoint patient allocation response adaptive procedures sequential sampling
Beschreibung
Zusammenfassung:Adaptive designs for multi-armed clinical trials have become increasingly popular recently because of their potential to shorten development times and to increase patient response. However, developing response-adaptive designs that offer patient-benefit while ensuring the resulting trial provides a statistically rigorous and unbiased comparison of the different treatments included is highly challenging. In this paper, the theory of Multi-Armed Bandit Problems is used to define near optimal adaptive designs in the context of a clinical trial with a normally distributed endpoint with known variance. We report the operating characteristics (type I error, power, bias) and patient-benefit of these approaches and alternative designs using simulation studies based on an ongoing trial. These results are then compared to those recently published in the context of Bernoulli endpoints. Many limitations and advantages are similar in both cases but there are also important differences, specially with respect to type I error control. This paper proposes a simulation-based testing procedure to correct for the observed type I error inflation that bandit-based and adaptive rules can induce
Beschreibung:Date Revised 31.01.2022
published: Print-Electronic
Citation Status PubMed-not-MEDLINE
ISSN:0266-4763
DOI:10.1080/02664763.2017.1342780