Details
During the first BASIC meeting, Council members received updates on several ongoing pilot activities including the Observational Medical Outcomes Partnership (OMOP), Mini-Sentinel, the Exploring and Understanding Adverse Drug Reactions (EU-ADR) Project, and the Vaccine Safety Datalink.
Recognizing similarities among these pilot activities, the Council considered potential opportunities for sharing findings and minimizing overlap. Following a presentation by McKinsey & Company on lessons learned from public-private partnerships and complex alliances in other industries, the Council discussed governance of the Sentinel System. Specifically, Council members explored the merits of potential organizational models focusing on governance for multiple users and multiple uses, economic sustainability, and ensuring participation of appropriate stakeholders.
Additional Information
Contributors
Janet Woodcock MD; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD
Rachel Behrman MD, MPH; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD
Judy Racoosin MD, MPH; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD
Richard Platt MD, MSc; Department of Population Medicine, Harvard Pilgrim Healthcare Institute and Harvard Medical School, Boston, MA