Adaptive Design Methods in Clinical Trials (2006)

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In recent years, the use of adaptive design methods in clinical trials has attracted much attention from clinical investigators and biostatisticians. Adaptations (i.e., modifications or changes) made to the trial and/or statistical procedures of on-going clinical trials based on accrued data have been in practice for years in clinical research and development. In the past several decades, we have adopted statistical procedures in the literature and applied them directly to the design of clinical trials originally planned by ignoring the fact that adaptations, modifications, and/or changes have been made to the trials. As pointed out by the United States Food and Drug Administration (FDA), these procedures, however, may not be motivated by best clinical trial practice. Consequently, they may not be the best tools to handle certain situations. Adaptive design methods in clinical research and development are attractive to clinical scientists and researchers due to the following reasons. First, they do reflect medical practice in the real world. Second, they are ethical with respect to both efficacy and safety (toxicity) of the test treatment under investigation. Third, they are not only flexible but also efficient in clinical development, especially for early phase clinical development. However, there are issues regarding the adjustments of treatment estimations and p-values. In addition, it is also a concern that the use of adaptive design methods in a clinical trial may have led to a totally different trial that is unable to address the scientific/medical questions the trial is intended to answer.

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