Advantages of multi-arm non-randomised sequentially allocated cohort designs for Phase II oncology trials
| Autor: | Mossop, Helen, Grayling, Michael J, Gallagher, Ferdia, Welsh, Sarah, Stewart, Grant, Wason, James MS |
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| Přispěvatelé: | Grayling, Michael J [0000-0002-0680-6668], Gallagher, Ferdia [0000-0003-4784-5230], Welsh, Sarah [0000-0001-5690-2677], Stewart, Grant [0000-0003-3188-9140], Wason, James MS [0000-0002-4691-126X], Apollo - University of Cambridge Repository |
| Rok vydání: | 2021 |
| Popis: | 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. Cancer Research UK Cambridge Centre [C9685/A25177] |
| Databáze: | OpenAIRE |
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