Abstract
There is a growing interest in employing adaptive clinical trial designs in drug development. Adaptation is usually based on accumulative efficacy data alone. This article examines issues that can arise when an independent data monitoring committee must interface their safety concerns when adaptive changes based on efficacy are taking place. Several types of adaptive changes are examined and the degree of complexity that safety concerns might introduce is discussed. Recommendations are made for sponsor-data monitoring committee communications when the latter has safety concerns that make a particular kind of adaptation inadvisable. Recommendations are made for making adaptive change decisions, minimizing bias, and training DMC and sponsor staff for participation in adaptive design trials.
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Presented at First Annual DIA/FDA Statistics Forum, Bethesda, Maryland. March 5–7, 2007.
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Herson, J. Coordinating Data Monitoring Committees and Adaptive Clinical Trial Designs. Ther Innov Regul Sci 42, 297–301 (2008). https://doi.org/10.1177/009286150804200401
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DOI: https://doi.org/10.1177/009286150804200401