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Abstract:
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Medical devices vary widely, and, partly because of this, so do recommendations made by FDA staff throughout the approval-seeking process. In the spirit of continuing dialogue with statistical consultants and FDA staff, I will share some perspectives from my experience. An underlying theme is maintaining professional integrity as one member of a larger group, in a situation that can truly make or break your client. Specific topics will include: how being a member of an FDA Advisory Committee helps in understanding the responsibilities of the statistical consultant; the importance of obtaining clear understanding and agreement between the company and the FDA on the proposed indications for use, and its impact on study design and end points; and the influence of who the FDA reviewers are, including their own experience, on protocol development and reaching a protocol agreement.
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