Life-cycle management is a widely accepted concept for the development and marketing of medicines. At each step of this process, pre- and post-licensing, statisticians work to develop methods that can improve efficiency and can enhance decision-making through optimal study design, analysis and inference. The workshop aims to discuss the latest developments in statistical methodology and decision-making in exploratory development, confirmatory development, licensing decisions and management of benefits and risks post-licensing. The discussions will consider not only the methods themselves, but how best to integrate methods for use in a regulatory context. Beyond this, the meeting seeks to ask whether there are advances in the collection and understanding of real world data that can inform and improve the design of confirmatory clinical trials, and focuses on the practical challenges facing statisticians involved in drug development.
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