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Abstract:
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Adaptive designs can facilitate earlier and better data-driven decisions, with increased efficiency, improving the probability of technical success for compounds moving forward. Traditional early-phase studies often are fairly flexible, but lack rigor. Details on design changes and data analysis may be determined after the study is ongoing. This approach can minimize the timeline for protocol development; however, changes on the fly complicate implementation and interpretation. Adapting by design (prespecifying the adaptive mechanism) still allows for some flexibility while providing an increase in information in a more optimally efficient way. This presentation will provide an overview of adaptive design approaches (advantages and disadvantages) in early exploratory development. Clinical trial examples will be presented with a discussion of practical barriers encountered.
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