This conference will provide a venue to discuss important statistical issues associated with the development and review of therapeutic drugs and biologics. A primary focus for this meeting will be to establish an ongoing, annual dialogue in an open, public forum, regarding FDA’s “Critical Path” initiative – emphasizing the regulatory and statistical challenges associated with innovative approaches to the design and analysis of clinical trials data.

This conference will be an opportunity for statisticians, clinicians and other interested professionals from industry, academia, CROs, and government agencies to learn about and discuss the 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 need this opportunity to come together annually to describe issues, discuss solutions and review progress and problems. It’s important that all of the stakeholders examine their roles in this enterprise and ask the hard questions that need to be answered so that we can develop appropriate, scientific/regulatory consensus regarding our purpose and process.