An urn model for odds-ratio-based response-adaptive phase III clinical trials for two or more treatments.
Adaptive data-dependent allocation designs are used in phase III clinical trials having two or more competing treatments with sequential entrance of patients, in order to allocate a larger number of patients to the better treatment. The odds ratio is a popular concept for biomedical practitioners; hence, odds-ratio-based adaptive designs could be very useful in practice. Rosenberger et al. (2001) introduced an odds-ratio-based two-treatment response-adaptive design; however, they did not study the properties in details. In this article, we describe these designs by means of urn models and provide limiting results for them. Some properties of the design are also studied numerically. We compare the performance of the proposed design with some possible competitors with respect to a few criteria. A real dataset is used to illustrate the applicability of the proposed design. Thus, we provide a base for using odds-ratio-based response-adaptive designs in practice. We extend our design for covariates and also for more than two treatments. In particular, we study the three-treatment design in this article.
Basak
Gopal K
GK
Statistics and Mathematics Unit, Indian Statistical Institute, Kolkata, India.
Biswas
Atanu
A
Volkov
Stanislav
S
D018687:Antidepressive Agents, Second-Generation / Q000627:therapeutic use; D017326:Clinical Trials, Phase III as Topic / Q000706:statistics & numerical data*; D003627:Data Interpretation, Statistical; D003866:Depressive Disorder / Q000188:drug therapy; D004941:Esophagitis / Q000188:drug therapy; D005473:Fluoxetine / Q000627:therapeutic use; D005765:Gastrointestinal Agents / Q000627:therapeutic use; D006801:Humans; D015233:Models, Statistical; D015337:Multicenter Studies as Topic / Q000706:statistics & numerical data*; D016017:Odds Ratio; D018579:Patient Selection; D016032:Randomized Controlled Trials as Topic / Q000706:statistics & numerical data*; D018401:Sample Size; D016896:Treatment Outcome
D018687:Antidepressive Agents, Second-Generation; D005765:Gastrointestinal Agents; D005473:Fluoxetine