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Keywords: Advisory committee statisticians
Public health is enhanced by evidence-based medicine, where interests of the public are protected by oversight of the research process provided by regulatory authorities such as FDA. Their goal is not simply to ensure availability of interventions to enable the public to have “choices,” but rather to ensure there are adequate insights about benefits and risks of these interventions to enable “informed choices.” External scientists, including biostatisticians, have favorably influenced this process through service as FDA Advisory Committees members, providing FDA advice based on their evaluation of available scientific evidence about effects of interventions. Advisory Committee statisticians have substantive opportunities and responsibilities to enhance the objectivity of the review process, seeking to ‘determine whether’ rather than to ‘establish’ that experimental interventions are safe and effective. Statisticians need not only strong training in theory, but also depth of insights into the art of properly applying scientific methods to effectively address real world problems. Strong communication skills also are key, given many advisory committees have only a single statistician. The statistician should be fully engaged in advisory committee interactions, at times being a teacher of statistical principles, and often needing to strategize about how best to use limited time to have the greatest positive influence. Being broadly engaged is proper, recognizing that issues should be viewed, not as being “statistical” vs “clinical” but rather as being “scientific”. While working to enhance objectivity and common sense in the research process, the statistician should strive to serve as the “conscience of the research team”, having the courage to advocate for the truth even when being in the minority on key issues, and to ‘make a difference’ in assisting the Agency to more effectively address their critically important mission.