Decision rules for identifying combination therapies in open-entry, randomized controlled platform trials.

ABSTRACT: Platform trials have become increasingly popular for drug development programs, attracting interest from statisticians, clinicians and regulatory agencies. Many statistical questions related to designing platform trials-such as the impact of decision rules, sharing of information across cohorts, and allocation ratios on operating characteristics and error rates-remain unanswered. In many platform trials, the definition of error rates is not straightforward as classical error rate concepts are not applicable. For an open-entry, exploratory platform trial design comparing combination therapies to the respective monotherapies and standard-of-care, we define a set of error rates and operating characteristics and then use these to compare a set of design parameters under a range of simulation a

SUBMITTER: Meyer EL 

PROVIDER: S-EPMC9304586 | biostudies-literature | 2022 May

REPOSITORIES: biostudies-literature