The Reagan-Udall Foundation and Pfizer Inc. are launching a pilot project to test approaches to conducting post-market drug safety research using FDA’s Sentinel data network without the agency’s involvement.

FDA is the only organization currently using the Sentinel post-market electronic data network, which has become a regular part of the agency’s safety surveillance activities for drugs, biologics and vaccines. However, the agency has been looking for ways the system could be used by drug industry stakeholders and others Also see "Mini Sentinel Data Covers 126 Million Patients; FDA Weighing Potential Uses For Drug Industry" - Pink Sheet, 23 January, 2012.. Coordinated by researchers at Harvard Pilgrim, the network includes insurance claims data and electronic medical records for approximately 178 million individuals.

The Reagan-Udall project involves the foundation’s Innovation in Medical Evidence Development and Surveillance (IMEDS) Evaluation program, which is a public-private partnership created to build on the progress made in research methodology by Sentinel and by the industry-funded Observational Medical Outcomes Partnership (OMOP). The OMOP operations were transferred to the Reagan-Udall Foundation and merged with IMEDS in 2013 Also see "Post-Market Drug Surveillance Research Methods Are Focus Of Reagan-Udall Program" - Pink Sheet, 1 February, 2013..

“IMEDS Evaluation is really created to establish a parallel universe to FDA’s Sentinel program,” IMEDS Chief Implementation Officer Troy McCall explained at the Reagan-Udall Foundation annual meeting May 15. The Reagan-Udall Foundation was created by Congress in 2007 to advance FDA regulatory science.

“It’s the only place that any non-FDA stakeholder can go to access these methods tools and data sets,” McCall pointed out. “What we’re hoping to accomplish is to blend the knowledge and experience that we gain with IMEDS methods [research] along with all the extensive experience that has been developed within Sentinel to continue to improve both IMEDS Evaluation as well as the Sentinel system.”

With funding from Pfizer, the organization has embarked upon a pilot project that will involve two phases, McCall said.

Phase one will establish the policies and procedures that will govern how IMEDS Evaluation will run once it reaches full production mode.

Among the policy and procedure issues to be resolved is when to bring FDA into the loop and when a company should announce research results.

“At what point do we inform the FDA that a company wishes to ask a question about one of its marketed products?” McCall said. “At what point do we involve FDA in that query process? What’s the timeline by which a company needs to publicly announce the findings, positive or negative, from the results of a query process?”

The organizers and stakeholders involved have developed a first draft of policies and procedures, he said.

In the second phase of the project, IMEDS will “pressure test those policies and procedures and ask the [Sentinel] system two specific queries that are important to a company, and we believe to the broader universe, and better understand whether those policies and procedures are going to work once we are in full production mode,” McCall explained.

In preparation for that, IMEDS is developing relationships with Sentinel’s 18 data partners so it can access their distributed data networks and query the system.

“We don’t expect [the draft policies and procedures] to work in their fullest extent at this point but we do believe that they’re strong enough to pressure test the system and see how well we do in phase two,” he commented. He said IMEDS hopes to start phase two of the project this quarter and conclude the pilot in the third quarter.

Research Method Refinement Welcomed By FDA

At the meeting, FDA’s Robert Ball said the agency welcomes work that can help refine the research methods being used in the Sentinel system. Ball is deputy director of the Office of Surveillance and Epidemiology in the agency’s Center for Drug Evaluation and Research.

He pointed out that Sentinel researchers continue to refine their research methods and that IMEDS’ activities could help facilitate those efforts.

“In this year’s research agenda, the Sentinel group has developed a number of new methods,” Ball explained. “One of the goals of the scientific agenda is for third parties to actually evaluate those methods in data that’s outside of Sentinel and define their performance characteristics. That’s a very concrete and useful way for us at FDA to understand how these methods perform. And going forward, the whole idea of a place where methods can be developed, tested and implemented is really critical for how FDA can transparently further this whole field.”

Reagan-Udall, Pfizer Testing Ways To Tap Sentinel Network Without FDA

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