Advantages of multi-arm non-randomised sequentially allocated cohort designs for Phase II oncology trials
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. Motivated by the WIRE trial in renal cell carcinoma (NCT03741426)...
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| Published in: | British journal of cancer Vol. 126; no. 2; pp. 204 - 210 |
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| Main Authors: | , , , , , |
| Format: | Journal Article |
| Language: | English |
| Published: |
England
Nature Publishing Group
01.02.2022
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| ISSN: | 0007-0920, 1532-1827, 1532-1827 |
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| Abstract | 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.
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.
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.
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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| AbstractList | 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.
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.
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.
We recommend the MASTER design as an efficient way of testing multiple promising cancer treatments in non-comparative Phase II trials. 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.BACKGROUNDEfficient 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.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.METHODSMotivated 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.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.RESULTSThe 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.We recommend the MASTER design as an efficient way of testing multiple promising cancer treatments in non-comparative Phase II trials.CONCLUSIONSWe recommend the MASTER design as an efficient way of testing multiple promising cancer treatments in non-comparative Phase II trials. BackgroundEfficient 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.MethodsMotivated 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.ResultsThe 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.ConclusionsWe recommend the MASTER design as an efficient way of testing multiple promising cancer treatments in non-comparative Phase II trials. |
| Author | Wason, James M S Stewart, Grant D Gallagher, Ferdia A Welsh, Sarah J Mossop, Helen Grayling, Michael J |
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| DOI | 10.1038/s41416-021-01613-5 |
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| Snippet | Efficient trial designs are required to prioritise promising drugs within Phase II trials. Adaptive designs are examples of such designs, but their efficiency... BackgroundEfficient trial designs are required to prioritise promising drugs within Phase II trials. Adaptive designs are examples of such designs, but their... |
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| SubjectTerms | Adaptive Clinical Trials as Topic - methods Cancer therapies Clinical trials Clinical Trials, Phase II as Topic - methods Cohort Studies Computer Simulation - standards Efficiency Humans Hypotheses Kidney cancer Medical Oncology - methods Neoplasms - drug therapy Neoplasms - pathology Non-Randomized Controlled Trials as Topic - methods Oncology Patients Recruitment Renal cell carcinoma Research Design - standards Response rates Sample Size Simulation Surgery Treatment Outcome |
| Title | Advantages of multi-arm non-randomised sequentially allocated cohort designs for Phase II oncology trials |
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