After nearly five years of building and testing, with the FDA's Mini-Sentinel pilot project nearing the goal of becoming the agency's next-generation safety watchdog tool, experts discussing its future in Washington said they see tremendous potential in its progress to date as well as plenty of work to be done before realizing the program's full potential.

Started in 2009, today's Mini-Sentinel has incorporated the data and expertise of more than 30 collaborating institutions and health data records on 178 million individuals, making it what many speakers said would be an integral piece of the realization of the Institute of Medicine's vision for a learning health care system. Up and running though far from finished, the system already is providing scientists, statisticians and at least one drugmarker – Pfizer Inc. – rapid access to comprehensive and actionable information on product safety.

The system's large, distributed and evolving dataset has already proved capable of rapidly informing regulatory decisions, said Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research (CDER), who keynoted the seventh annual Sentinel Initiative public workshop, hosted by the The Brookings Institution on Thursday.

Despite that benefit, she said, uncertainties about Sentinel's data remain, leaving it far from determinative in the FDA's decision-making. The system is maturing under the aegis of a $150 million contract with Mini-Sentinel's builder, Harvard Pilgrim Health Care Institute. However, Woodcock said, "we have to continue to invest in activities to understand how to harness the data to inform us more about the safety of medical products" to make it more robust and reliable, so the agency can put "more weight" on the data going forward and understand why it's confounded when it is.

As part of the journey from pilot to fully sustained surveillance system, Woodcock announced Thursday that she's transitioning leadership and management for the program from CDER's Office of Medical Policy to its Office of Surveillance and Epidemiology in a bid to completely integrate Sentinel capabilities into CDER's pharmacovigilance activities.

The FDA is also negotiating for access to new data from some of the nation's largest medical records holders, the Centers for Medicare & Medicaid Services, the Department of Veterans Affairs, the Department of Defense and Centers for Disease Control and Prevention, the eventual integration of which could consume much of the next five years, a period during which Woodcock said Sentinel's real return on investment would begin to become more broadly apparent.

Substantial investments made by Harvard and its collaborators to establish common data models are paving the path for the inclusion of yet more outside data, said Richard Platt, executive director, professor and chair in Harvard's department of population medicine. That work undergirds a growing body of sophisticated adjusted comparisons between products produced by Mini-Sentinel that have showcased the platforms potential for cutting millions from the typical costs of investigating subjects the agency finds interesting, such as the comparative risk for angioedema among blood pressure control medications.

Stakeholders at the meeting acknowledged the necessity of treading carefully in a world where medical privacy issues are growing more and more fractious, a problem highlighted by Thursday's news that hackers had breached Anthem Inc. to access information about nearly 40 million U.S. customers and company employees.

But Sentinel's momentum appeared clear, as the system's architects and supporters work to add ever more data through new partnerships, such as those with HCA Holdings Corp.'s 165 hospitals, which are now contributing de-identified pharmacy data to the system.

Karla Miller, HCA's assistant vice president of pharmacy services and clinical therapeutics, said she hoped would lead to the kind of learning healthcare system so many policymakers have envisioned. But, if Michael Nguyen, deputy director of the the Center for Biologics Evaluation and Research's division of epidemiology is right, there's still a lot of work to be done. While commending Sentinel's "tremendous potential," Nguyen took pains to emphasize that it's still being built.

"If this were a house," he said, "the walls and the structure are up, but we're still working on the plumbing and the electrical."