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Pharmaceutical and biotech companies are increasingly interested in the use of ‘adaptive’ clinical trials to improve the process of drug development. By an ‘adaptive trial’, we mean a trial that is designed from the outset to review key response data as we collect it, and carry out certain pre-specified adaptations in the light of what we learn.
In large confirmatory trials, regulatory concerns will limit adaptations that can be considered to actions such as stopping the trial early, performing a sample size re-assessment or dropping a treatment arm. In early phase trials, frequent adaptation and a wider scope for adaptation are permitted, for instance: frequent optimisation of the probabilities of adaptation to the different treatment arms; more frequent interims to choose to drop or add treatment arms or to stop the trial; modification of inclusion and exclusion criteria to drop patient subpopulations from the study or restrict the study to a sub-population.
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