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Abstract:
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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. These delays can mean it takes longer for patients to have access to potentially beneficial medical devices; they also are exceptionally costly for sponsors. As part of their strategic objectives, CDRH 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 how to conduct oneself during communications with the FDA review team can streamline negotiations with the FDA-and, ultimately, grant patients access to safe and effective medical devices as soon as possible.
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