Prior FDA Grand Rounds presentation

Presented by

Richard A. Forshee, PhD
Associate Director for Research
Office of Biostatistics and Epidemiology
FDA's Center for Biologics Evaluation and Research

Webcast Lecture

Uncertainty is the only certainty there is: Potential approaches for making public health decisions

About the Presentation

In 2012, FDA's Center for Biologics Evaluation and Research (CBER) was reviewing a submission for the first home-use HIV test kit. Among the many important questions discussed were:

1. What is the sensitivity and specificity of the test?
2. Who was likely to use it?
3. Would people switch from professional testing to home-use testing?
4. Would early detection with test reduce HIV transmission?

Formal benefit-risk assessment was used to address these questions and the results of the analysis were presented to the Blood Products Advisory Committee.

Many significant public health decisions face such uncertainty and yet the decisions still must be made. We must frequently consider data and analyses from disparate sources, including randomized clinical trials, large observational studies, reported international experience, passive surveillance, case studies, and animal studies when deciding on product approval or regulatory policy. Formal benefit-risk assessment approaches can help decision-makers understand how the key sources of uncertainty affect their decisions and help to integrate different types of data and analyses in their deliberations.

A benefit-risk assessment framework can serve as the foundation for communication strategies both among the decision-makers and with the broader community of stakeholders. This presentation will introduce key benefit-risk assessment concepts and tools and show examples where formal benefit-risk assessment has supported difficult public health decisions.

About the Presenter

Dr. Richard Forshee leads the Analytics and Benefit-Risk Assessment Team for CBER's Office of Biostatistics and Epidemiology at FDA. He works on a wide range of issues related to the risks and benefits of blood and blood products and vaccines as well as human cell and tissue products. Dr. Forshee has won numerous awards, including the FDA Service Award and the CBER Hope Hopps Memorial Award. He has published more than 60 scientific articles. Before joining FDA, he was the Director of the Center for Food, Nutrition, and Agriculture Policy at the University of Maryland, College Park.