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# Building a National Evidence Generation System
- URL: https://www.fdaweb.com/building-a-national-evidence-generation-system/
- Published: 2016-05-04T12:00:00.000Z
- Updated: 2026-09-14T20:59:18.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5135565

FDA associate deputy commissioner for medical products and tobacco **Rachel Sherman** and commissioner **Robert Califf** say there are several principles that must be kept in mind as interoperability and connectivity are used to build a national system for evidence generation. Writing in an *FDA Voice* blog [post](http://blogs.fda.gov/fdavoice/index.php/2016/05/what-we-mean-when-we-talk-about-evgen-part-ii-building-out-a-national-system-for-evidence-generation?ref=fdaweb.com), they list the principles as: 

- a common approach to how data is presented, reported, and analyzed, and strict methods for ensuring patient privacy and data security;
- rules of engagement that are transparent and developed through a process that builds consensus across the relevant ecosystem and its stakeholders; and
- system output must be intended for the public good and be readily accessible to all stakeholders to ensure support across a diverse ecosystem that often includes competing priorities and incentives.

The two say that it may be helpful to envision evidence generation as an umbrella for all activities that help inform all stakeholders about making treatment decisions. They note that while evaluating drugs, biologics, or medical devices encompasses different data needs and methods, all share a common attribute — the characterization of individuals and populations and their associated clinical outcomes after they have undergone diagnostic or prognostic testing or been exposed to a therapeutic intervention. “Moreover,” they say, “when medical practice itself is part of the evaluation, characterization of the organization and function of delivery systems is critical. In other words, the kinds of evidence needed to evaluate medical products for safety and effectiveness and the kinds of evidence needed to guide medical practice overlap substantially.”

The post looks at a number of efforts in which progress has been made in “secondary use,” in which data collected for one purpose such as part of routine clinical care can be reused for another purpose such as research, safety monitoring, or quality improvement. Sherman and Califf write about the Sentinel initiative, the National Patient-Centered Clinical Research Network, the National Institute of Health’s Health Care Systems Research Collaboratory, and the Reagan-Udall Foundation Innovation in Medical Evidence Development and Surveillance Evaluation Program.