Journal
BRITISH JOURNAL OF CANCER
Volume 126, Issue 2, Pages 204-210Publisher
SPRINGERNATURE
DOI: 10.1038/s41416-021-01613-5
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Funding
- Cambridge University Hospitals NHS Foundation Trust (CUH)
- University of Cambridge (UoC)
- AstraZeneca UK
- Cancer Research UK
- Mark Foundation Institute for Integrated Cancer Medicine (MFICM)
- Mark Foundation for Cancer Research (NY, USA)
- Cancer Research UK Cambridge Centre (UK) [C9685/A25177]
- NIHR Cambridge Biomedical Research Centre [BRC-1215-20014]
- MRC Clinical Academic Research Partnership grant
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Efficient trial designs are crucial for prioritizing promising drugs in Phase II trials. Three trial approaches were compared in a simulation study, with the MASTER design showing extra efficiency in cases of endpoint delay or rapid recruitment. The study recommends the MASTER design as an efficient way to test multiple promising cancer treatments in non-comparative Phase II trials.
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 simulation study to compare how long the three different trial designs take to evaluate a number of new treatment arms. Results The parallel multi-arm multi-stage and the MASTER design are much more efficient than separate trials. The MASTER design provides extra efficiency when there is endpoint delay, or recruitment is very quick. Conclusions We recommend the MASTER design as an efficient way of testing multiple promising cancer treatments in non-comparative Phase II trials.
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