FDA to use EHR data for drug monitoring
The intent is for the FDA to continually assess the drugs after they go to market, as mandated by law.
To that end, the FDA launched its Sentinel Initiative, a long-term program designed to build and implement an electronic system for monitoring the safety of medical products in the post market setting.
The agency has created infrastructure on which to run the program through its Mini Sentinel pilot, a distributed database with access to more than 150 million patient records has been created (the Sentinel Distributed Database).
In order to optimally leverage the data, however, new analytic methodologies will be required.
According to the notice posted in the Federal Register, eligibility is limited to the Reagan-Udall Foundation, which has established the IMEDS-Methods program, which is uniquely positioned to develop the new methodologies required for FDA to conduct effective active post-market safety surveillance of medical products using large electronic healthcare data.
The IMEDS organization has developed a network of statisticians, epidemiologists, data scientists and clinicians who have experience operating in both the IMEDS research laboratory and also familiarity with the Sentinel Distributed Database. In addition, through the Reagan-Udall Foundation public-private partnership, the IMEDS-Methods program has a unique ability to convene FDA, patients, academics, government and industry so that the findings and tools developed through its research agenda will be promulgated and adopted.
Applications deadline is June 15. The one-year grant period begins a month later.
Read the Federal Register notice here.