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533 - Biopharmaceutical Section P.M. Roundtable Discussion (Added Fee)
Type: Roundtables
Date/Time: Wednesday, August 2, 2017 : 12:30 PM to 1:50 PM
Sponsor: Biopharmaceutical Section
Abstract #324932
Title: Beyond the Statistical Analysis Plan: Statisticians Partaking Earlier in Design of Clinical Trials
Author(s): Yuqun Abigail Luo*
Companies: FDA
Keywords: Clinical Trial Design ; Eligibility Criteria ; Proposed Indication ; Endpoint Choice
Abstract:

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.


Authors who are presenting talks have a * after their name.

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