Abstract:
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Frequently, statisticians in the pharmaceutical industry and regulatory agencies are called upon to develop or evaluate the Statistician Analysis Plan of a clinical trial, with many aspects of the overall trial design arrived already fixed, e.g., eligibility criteria, whether to use a control arm, endpoint, etc. However, from our experience, the overall clinical development of an investigational product can benefit substantially from earlier participation of a statistician who understands the subject matter. Questions that can benefit from substantive collaboration of product, clinical, and statistical expertise include: (1) Potential proposed indications, given the current treatment landscape and the product characteristics; (2) Study population and choice of endpoints that can support the proposed indication; (3) Whether seemingly sensible endpoints from a clinical perspective are genuinely well-defined; and others. Contrived examples in oncology and coagulation factors, drawing from publicly available information, will be discussed. Participants will be encouraged to share their experience and insights.
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