The meeting is intended to be an annual, open dialogue to discuss FDA’s issues, initiatives and guidance – emphasizing the statistical and regulatory challenges.



The conference is an opportunity for statisticians, clinicians and other interested professionals from industry, academia, CROs, and government agencies to learn about and assess current and emerging statistical methodologies and quantitative approaches used to develop evidence of the efficacy and safety of new drug and biologic therapeutic products.



We use this opportunity to come together annually in the Washington, DC area to describe important issues, discuss solutions and review progress and problems. We feel that it is important for all stakeholders to examine their roles in this enterprise and ask the hard questions that need to be answered – to develop appropriate, scientific/regulatory consensus regarding our purpose and process.