Statistics Collaborative - Design and analysis for biomedical research



SCI has had considerable interaction with the Food and Drug Administration (FDA). We have met with groups at the Center for Drug Evaluation and Research (CDER), the Center for Biologics Evaluation and Research (CBER), and the Center for Devices and Radiological Health (CDRH). Dr. Janet Wittes has participated as a regular and as an ad hoc member on several FDA Advisory Committees. SCI staff has participated in many meetings at the FDA, including early phase, End of Phase 2, special meetings, and Advisory Committees where SCI staff has presented on behalf of our clients. Dr. Wittes has presented several seminars to FDA staff - both to medical reviewers and statisticians - on statistical methodology and safety monitoring.

In addition to our interactions with the FDA, we have provided advice to clients dealing with European regulatory bodies, such as the European Medicines Agency (EMA).

In our work with clients preparing for regulatory submission and review, we provide an independent, critical eye for reviewing protocols, analytic plans, and submissions to the FDA. Clients frequently come to us to analyze data that pose particular problems. We often participate in mock FDA panels where we play the role of FDA panelists. Companies use such panels to evaluate and modify the written submissions and verbal presentations they have prepared for FDA panels. Our experience with many FDA submissions and our service on FDA panels allow us to provide useful advice to sponsors. We analyze data that pose particular problems. We evaluate the statistical analyses and summaries, assess the written interpretations, and advise on improvements.