Using the example of the recently reported phase III MAIA trial, we emphasize herein the requirement to dig deeper into trial designs and end points to determine their appropriateness for the questions at hand and to assess whether a benefit in terms of the primary end point — even if statistically significant and seemingly clinically meaningful — is sufficient to warrant a change in clinical practice.
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Acknowledgements
The work of the authors is supported in part by grants CA107476, CA168762 and CA186781 from the US National Cancer Institute.
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P.K. is the principal investigator of trials for which the Mayo Clinic receives research funding from Amgen, GlaxoSmithKline, Janssen, Sanofi and Takeda. S.V.R. declares no competing interests.
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Kapoor, P., Rajkumar, S.V. MAIA under the microscope — bringing trial design into focus. Nat Rev Clin Oncol 16, 339–340 (2019). https://doi.org/10.1038/s41571-019-0198-0
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DOI: https://doi.org/10.1038/s41571-019-0198-0
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