A session held at FDA’s Sentinel Initiative Public Workshop held in Washington D.C. on January 9th, discussed what is ahead for the “Innovation in Medical Evidence Development and Surveillance” program or referred to as the IMEDS-Methods program which operates within the Reagan-Udall Foundation (RUF). RUF an independent organization, is helping FDA by initiating research on the methods needed to evaluate safety.
Mark McClellan, Senior Fellow and Director of the Initiative on Value and Innovation in Health Care at the Brookings Institution and Chair of FDA’s RUF presented his thoughts at a session on the progress of the IMEDS-Methods program and their research agenda.
FDA’s Sentinel Initiative, a national electronic system is intended to help FDA track the safety of marketed drugs, biologics, and medical devices. Originally, FDA introduced the Sentinel Initiative in 2008, to develop and implement a proactive system that would complement existing systems that FDA has in place to track reports of adverse events linked to the use of FDA’s regulated products. The FDA Mini-Sentinel program, part of the Sentinel program focuses on assessments, methods, or data.
The IMEDS-Methods program in supporting research works to provide safety evaluations in large databases. The IMEDS-Methods program’s plan is to improve tools for conducting post-marketing safety surveillance using automated healthcare data. The goal is to support FDA’s full Sentinel System and provide ready public access to accurate archives of documentation and datasets.
The development of the IMEDS-Methods Research Agenda began in September 2013 at the IMEDS Scientific Advisory Committee meeting where the committee examined a draft research agenda to review comments from stakeholders and from Mini-Sentinel investigators plus others.
The modified document was presented to the IMEDS Steering Committee in October where the Steering Committee voted to accept the agenda. IMEDS anticipates that the research agenda will undergo periodic modifications and revisions as needed.
The anticipated research projects resulting from the release of the IMEDS-Methods Research Agenda will involve releasing Requests for Proposals (RFP). It is anticipated that responses will come from many qualified sources such as current investigators, Mini-Sentinel investigators, plus other appropriate applicants from the research community when the RFPs are made public. The IMEDS program will also look at investigator initiated proposals for projects not outlined in the research agenda, as long as they fit in with the IMEDS program and RUF missions.
To view the IMEDS-Methods Research Agenda, go to http://imeds.reaganudall.org/node/637.