Advantages of multi-arm non-randomised sequentially allocated cohort designs for Phase II oncology trials.
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Authors
Mossop, Helen
Publication Date
2021-11-08Journal Title
Br J Cancer
ISSN
0007-0920
Publisher
Springer Science and Business Media LLC
Language
eng
Type
Article
This Version
AM
Metadata
Show full item recordCitation
Mossop, H., Grayling, M. J., Gallagher, F., Welsh, S., Stewart, G., & Wason, J. M. (2021). Advantages of multi-arm non-randomised sequentially allocated cohort designs for Phase II oncology trials.. Br J Cancer https://doi.org/10.1038/s41416-021-01613-5
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 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.
Sponsorship
Cancer Research UK Cambridge Centre [C9685/A25177]
Funder references
MRC (MR/T024097/1)
Cancer Research UK (C96/A25177)
Identifiers
External DOI: https://doi.org/10.1038/s41416-021-01613-5
This record's URL: https://www.repository.cam.ac.uk/handle/1810/329684
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