Abstract
The use of adaptive designs in dose ranging studies can increase the efficiency of drug development by improving our ability to efficiently learn about the dose–response and better determine whether to take a drug forward into confirmatory phase testing and at what dose. This approach can maximize the ability to test a larger number of doses in a single trial while simultaneously increasing the efficiency of the trial in terms of making better go–no-go decisions about continuing the trial and/or the development of the drug for a specific indication.
We show in a real case study of a dose ranging trial in patients with acute exacerbations of schizophrenia how such an adaptive design explicitly addresses multiple trial goals, adaptively allocates subjects according to ongoing information needs, and allows termination for both early success and futility.
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Dragalin, V., Krams, M. (2014). A Case Study for Adaptive Trial Design Consideration and Implementation. In: He, W., Pinheiro, J., Kuznetsova, O. (eds) Practical Considerations for Adaptive Trial Design and Implementation. Statistics for Biology and Health. Springer, New York, NY. https://doi.org/10.1007/978-1-4939-1100-4_17
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DOI: https://doi.org/10.1007/978-1-4939-1100-4_17
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