Advantages of multi-arm non-randomised sequentially allocated cohort designs for Phase II oncology trials.

ABSTRACT:

Background

Efficient trial designs are required to prioritise promising drugs within Phase II trials. Adaptive designs are examples of such designs, but their efficiency is reduced if there is a delay in assessing patient responses to treatment.

Methods

Motivated by the WIRE trial in renal cell carcinoma (NCT03741426), we compare three trial approaches to testing multiple treatment arms: (1) single-arm trials in sequence with interim analyses; (2) a parallel multi-arm multi-stage trial and (3) the design used in WIRE, which we call the Multi-Arm Sequential Trial with Efficient Recruitment (MASTER) design. The MASTER design recruits patients to one arm at a time, pausing recruitment to an arm when it has recruited the required number for an interim analysis. We conduct a simu

SUBMITTER: Mossop H 

PROVIDER: S-EPMC8770479 | biostudies-literature | 2022 Feb

REPOSITORIES: biostudies-literature