The passage of the Food and Drug Administration Amendments Act of 2007 mandated that the U.S. Food and Drug Administration (FDA) develop a system for postmarket risk identification and analysis. In response, FDA launched the Sentinel Initiative. FDA’s Mini-Sentinel pilot has made significant strides toward developing a national system for generating post-market safety evidence, and has succeeded in developing an effective distributed research network through a claims-based common data model. As the Sentinel Initiative enters the final year of the Mini-Sentinel pilot, FDA has identified the need to reduce the burden of data collection on the data owners and secondary data users as an area for further exploration.
On May 8, the Engelberg Center for Health Care Reform at Brookings convened an expert workshop, “Promoting the Effective Use of a Common Data Model,” to discuss the opportunities and challenges of adopting a common data model to support a broad range of stakeholder research and data needs. This strategic discussion focused on the potential of using a common data model as a tool to reduce the burden of data collection and the duplication of effort in order to support a stronger national capacity for health research and analysis. Representatives from the FDA, Sentinel data-partners, state all-payer claims databases, and federal agencies discussed their research and data needs, the utility of a common data model or several common data models to meet those needs, and the possibility of utilizing the Mini-Sentinel common data model as a base for broader adoption and expansion.
Lesley Curtis PhD; Duke University School of Medicine, Durham, NC