Quality & Compliance: Interactions With Regulatory Agencies to Enhance the Understanding and Acceptance of Adaptive Designs

Posted 01 April 2009 | By

An article published in the August 2008 issue of Regulatory Focus1 discussed the increasing use of adaptive designs in clinical development. The concept of adaptivity, i.e., making changes in response to emerging information, is not new. What is new is the extent to which adaptivity has been considered by researchers in recent years. To echo this sentiment, Bretz et. al.2 examine the principle of adaptivity and argue that, even though it has historically been used primarily in clinical trials, the concept of adaptivity is applicable to all stages of drug discovery and drug development. For example, it can be used by chemists when synthesizing compounds to meet a target property. It can be used by pharmaceutical sponsors to design exploratory and confirmatory clinical trials to assess a new pharmaceutical entity. It can be used by trialists to identify a subpopulation of patients with a particular disorder who could uniquely benefit from a new treatment modality. Even more, adaptivity could be used to design pediatric studies and trials to investigate bioequivalence between a brand and a generic or between two different formulations. Similarly, Chuang-Stein and Burman3 predict that adaptive designs are likely to become an increasingly common tool in our armamentarium of innovative approaches to develop and assess medical interventions in the future.


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