The Food & Drug Administration wants to take Sentinel, its two-year-old effort to develop a drug and medical device safety network, to the next level by testing how the system would work in the practical world of patients, doctors' offices and insurance companies.
To do so, the FDA in January awarded a $72 million contract to Harvard Pilgrim, a Wellesley, Mass., health plan, to help develop "Mini-Sentinel." The project involves "developing and testing methods and data sources for a fully operational Sentinel network," said Dr. Richard Platt, chairman of the Department of Population Medicine at Harvard Medical School and Harvard Pilgrim Healthcare Institute.
Sentinel allows the FDA to track potential adverse events involving new drugs, biological products and medical devices after they've been introduced into the healthcare market.
The FDA now relies on reports provided by hospitals, healthcare professionals and others in the industry for most of the raw information it uses to determine the safety of drugs and medical products. But these reports aren't always complete or delivered to the FDA in a timely manner.
"Mini-Sentinel is just getting started," said Platt. The project will extend the data stream Sentinel filters into everyday, practice- level healthcare environment and involve a team of more than 100 scientists at universities and healthcare organizations around the country, he said.
Systems the team is putting in place will gather data from electronic health record systems, administrative and insurance claims databases and medical registries.
Coordinating center
Harvard Pilgrim is building a coordinating center that will serve as a scaled down version of Sentinel. It will identify appropriate databases, develop a scientific framework for obtaining real-time data, and ensure data quality.
The pilot program will develop and test methods to actively monitor medical products and outcomes.
"One way to do that is to periodically evaluate the accumulating experience of a large number of people exposed to a product"for instance a drug"to determine whether they had more of certain kinds of outcomes than people [would] have if they weren't exposed," Platt said.
"Another way the system could work would be to provide quantitative information to help the FDA interpret signals of potential problems that arise from a variety of sources. We expect that answers are likely to come from information assembled from several different data holders."
Platt says Mini-Sentinel expects to use health plans' membership and billing data, medical practices' and hospitals' electronic medical records data, and disease and device registries. How upto- date the records will be will depend partly on the type of data and on the specific source.
"In other projects, the lag has ranged from a week to a few months," he said. There will be no large central data repository, Platt said. Instead, data holders (health plans, practices and hospitals) will keep their data, which would provide information about persons exposed to various drugs and medical products.
Data ownership
Data holders will use their own software to create files that conform to standard specifications. The analysis will be done using computer programs to be distributed by the center.
"Each data holder will [analyze] its own data," Platt said. The center would then "combine the results from separate sites to provide an overall assessment of a product's safety."
Platt said a key to the program's success will be the ability to track outcomes" a heart attack, for example" in electronic health data regardless of whether a patient or physician suspects it was caused by a drug or other product.
"These outcomes are usually diagnoses, but might also be abnormal laboratory test results or other occurrences," he said. "Since most of these outcomes can occur even without exposure to any medical product, we will usually look for an unexpectedly large number of these events."
Mini-Sentinel will help data holders contribute to better understanding of the safety and safe use of medical products, Platt says. The Harvard Pilgrim contract is one of the many projects underway to develop Sentinel, according to the FDA. The agency already has awarded 10 small contracts addressing scientific operations, data and infrastructure, privacy, and stakeholder engagement.
