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Abstract:
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In an effort to improve the global clinical development of new medicines, adaptive designs have been gaining popularity in all phases of clinical development. In general, adaptive designs are developed to increase the flexibility of clinical trials, such as modification of sample size based on interim outcomes, seamless phase II/III trial designs, response adaptive randomization, or early stopping for either futility or efficacy. Recently the FDA has issued the final guidance on adaptive designs for clinical trials of drugs and biologics. In this presentation, we will highlight some areas that adaptive designs are practical and efficient in clinical development. Such designs are useful in both the “learning” and “confirming” phases of development to increase the probability of success and reduce the number of patients exposed to ineffective treatments. Examples will be used to illustrate the design features of adaptation.
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