A modular framework for early-phase seamless oncology trials.

ABSTRACT:

Background

As our understanding of the etiology and mechanisms of cancer becomes more sophisticated and the number of therapeutic options increases, phase I oncology trials today have multiple primary objectives. Many such designs are now "seamless," meaning that the trial estimates both the maximum tolerated dose and the efficacy at this dose level. Sponsors often proceed with further study only with this additional efficacy evidence. However, with this increasing complexity in trial design, it becomes challenging to articulate fundamental operating characteristics of these trials, such as (1) what is the probability that the design will identify an acceptable, that is., safe and efficacious, dose level? or (2) how many patients will be assigned to an acceptable dose level on aver

SUBMITTER: Boonstra PS 

PROVIDER: S-EPMC8382494 | biostudies-literature | 2021 Jun

REPOSITORIES: biostudies-literature