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Activity Number: 566
Type: Roundtables
Date/Time: Wednesday, August 3, 2016 : 12:30 PM to 1:50 PM
Sponsor: Biopharmaceutical Section
Abstract #321113
Title: Best Practices for Discussing/Negotiating Endpoints, Hypotheses, Sample Size, and Other Study Design Aspects of Clinical Studies with FDA Reviewers
Author(s): Jennifer Mischke and Tyson Rogers*
Companies: NAMSA
Keywords: FDA ; Negotiations ; Study Design ; Best Practices ; Balance of Data
Abstract:

Statistical components of study designs are often among the most challenging discussions between a sponsor (and their consultants) and the FDA review team. These discussions can delay the start of a study by months-even years. Once the study has been conducted and results are finalized, these statistical components are once again a focus of discussion with the FDA and potentially a source of additional delays in approval or clearance. The impact of these delays means it takes longer for patients to have access to potentially beneficial medical devices, which can be exceptionally costly for sponsors. As part of their strategic objectives, the FDA is focusing on customer service, strong communication, and a balance of data. Understanding these initiatives, having a solid strategy for presenting and discussing statistical issues, and best practices for conducting oneself during communications with the FDA review team can streamline negotiations with the FDA and, ultimately, grant patients access to safe and effective therapies as soon as possible.


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

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