Lebovitz, Yeonwoo, English, Rebecca, Claiborne, Anne. "3 The Urgent Need for Regulatory Science." Building a National Framework for the Establishment of Regulatory Science for Drug Development: Workshop Summary. Washington, DC: The National Academies Press, 2011.
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Building a National Framework for the Establishment of Regulatory Science for Drug Development: Workshop Summary
FDA statisticians, observed Ellenberg, have little discretionary time for methodological research. Conversely, research statisticians may not be informed of the regulatory constraints or pitfalls commonly known to regulatory scientists. Therefore, some approaches recommended by research scientists in published journals go unnoticed by agency scientists.
To make progress, said Ellenberg, two components are necessary: first, FDA statisticians who are adept at using newly developed approaches must be empowered to judge whether methods should be applied based on their appropriate scientific value; second, research statisticians must be knowledgeable about the regulatory environment so the advances created by their research will be relevant to, and take into account, issues faced by FDA. A regulatory science infrastructure can provide the mechanism to fill the gap between these two bodies of knowledge that otherwise delays innovation.