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Decision‐making in early clinical drug development
Authors:Paul Frewer  Pat Mitchell  Claire Watkins  James Matcham
Institution:1. Early Clinical Development Biometrics, AstraZeneca, Royston, UK;2. Clarostat Consulting Ltd., Alderley Edge, UK
Abstract:This paper illustrates an approach to setting the decision framework for a study in early clinical drug development. It shows how the criteria for a go and a stop decision are calculated based on pre‐specified target and lower reference values. The framework can lead to a three‐outcome approach by including a consider zone; this could enable smaller studies to be performed in early development, with other information either external to or within the study used to reach a go or stop decision. In this way, Phase I/II trials can be geared towards providing actionable decision‐making rather than the traditional focus on statistical significance. The example provided illustrates how the decision criteria were calculated for a Phase II study, including an interim analysis, and how the operating characteristics were assessed to ensure the decision criteria were robust. Copyright © 2016 John Wiley & Sons, Ltd.
Keywords:decision criteria  operating characteristics  interim analysis  three‐outcome designs
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