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The new Sentinel system aims to expand access to data on medical product safety and patient effects.
Public and private healthcare experts have been struggling for years to establish electronic health information systems able to track and transfer a broad range of data in patient medical records. The inability of the nation's fragmented health IT (HIT) systems to communicate with one another has made the task extremely difficult, as do concerns about patient privacy and protecting access to personal health information (PHI).
The US Food and Drug Administration hopes that increased connectivity among healthcare entities will support more efficient drug testing and development, along with more timely medical product monitoring and oversight. To take advantage of these developments, the FDA is working to update its internal IT operations to improve its capacity for reviewing applications for new drugs and medical products, for receiving and archiving clinical trial data and regulatory submissions, and for tracking manufacturing facilities and product supply chains.
A main goal is to expand oversight of the safety of drugs and medical products on the market. To this end, the FDA is centralizing adverse event analysis through an all-FDA adverse event (AE) reporting system and is creating a MedWatch Plus single portal for public reporting of AE information. Work continues on a final rule requiring electronic filing of AE reports for drugs, biologics, vaccines, and medical products, a mandate that smaller drug and biotech manufacturers fear will be costly and challenging.
Probably the most high-profile project involves establishing a proactive information system that can detect signals of adverse events for regulated products. The aim, as specified in the FDA Amendments Act of 2007 (FDAAA), is to augment the agency's passive AE reporting system with a more active program able to monitor health records on 100 million people by July 2012.
To meet this goal, FDA launched the Sentinel Initiative in 2008 and is now establishing a mini-Sentinel system that will tap into medical records held by large health plans and insurers. FDA will pose questions triggered by risks seen in clinical trials or by early AE reports to databases established by CIGNA, Kaiser Permanente, and the HMO Research Network, among others. A second phase next year will broaden access to include data from Medicare and other government health programs.
To coordinate operations, FDA recently signed a $72 million contract with the Harvard Pilgrim Health Care system to implement a distributed data model that can obtain near real-time signals and ensure data quality from appropriate sources. The system permits FDA to ask Sentinel partners to monitor for certain events and to assess evidence of health conditions associated with drug use. The program already can access information on 60 million patients, according to Project Director Richard Platt of Harvard Pilgrim and Harvard Medical School. That's well above the 25 million patients that FDAAA instructs FDA to monitor by July 1 of this year. Mini-Sentinel also will work with researchers and technical experts at academic centers, private firms, and non-profit organizations to examine methods for querying against a common data model and to establish policies and standards for validating and analyzing information from diverse information sources.
Platt and others discussed the technical, legal, and administrative issues involved in building the Sentinel system at a January workshop organized by Mark McClellan, former FDA commissioner and now director of the Engelberg Center for Health Care Reform at the Brookings Institution. FDA Commissioner Margaret Hamburg opened the conference by emphasizing the importance of post-marketing surveillance of regulated products. To have a fully functioning Sentinel system, she noted, we need to examine how to design a common data model that can compare and analyze data sets, and to reach consensus on methodologies for proving and disproving causal relationships between a product and an outcome.
Janet Woodcock, director of the Center for Drug Evaluation and Research, described Sentinel as one element in a broader FDA effort to encourage the safe use of medications, to revamp the agency's pharmacovigilance system and to explore the use of social media to publicize safety problems. Sentinel is "very much a work in progress," Woodcock commented, noting that it will be very different in five years as the science and technology mature.
The FDA's decision to launch Sentinel based on a distributed data model reflects earlier research by academic experts and by the Observational Medical Outcomes Partnership (OMOP), an industry-funded collaboration involving the FDA, the Foundation for the National Institutes of Health and the Pharmaceutical Research and Manufacturers of America. Through this partnership, manufacturers are working to define viable approaches for assessing drug safety and for communicating those findings to health professionals and patients.
OMOP's agenda reflects strong industry interest in shaping and supporting Sentinel policies and operations. Unfortunately, this coalition is the main way for manufacturers to influence the project at this time because there are no industry representatives on the Sentinel planning board and OMOP is not an official participant in the program, largely because some stakeholders believe that manufacturer involvement could taint the validity of results. A main concern of the industry is that companies will be denied access to Sentinel data for their own analysis or for postmarketing studies. Woodcock noted that the mini-Sentinel system cannot yet support third-party postmarketing analyses, and that the FDA will have to deal with industry access after the full "industrial-strength" Sentinel emerges.
Ensuring the privacy and security of patient health records is another key issue shaping the Sentinel program. The main advantage of the distributed data model is that the FDA avoids building its own mega-database and instead leaves individual patient health information with the insurance company or health system that holds the records. That data source evaluates the information, transmits summaries to Sentinel, and confirms a specific diagnosis or report if needed. It remains to be seen how well the FDA can assess safety signals through this arrangement; even direct access to de-identified data may not be sufficient to confirm that a safety issue is real.
Another tricky issue for industry and policy makers is the timing of public disclosure of safety information. Releasing information too early increases the possibility that a report may be wrong or incomplete and thus raise unnecessary alarm. But delaying communication on an emerging safety problem may result in patient harm and expose program participants to "failure to warn" liability charges. Moreover, the FDA has to determine how it will use Sentinel findings in regulatory decisions. Confirmation of safety signals could result in changes in a product's labeling, agency alerts to healthcare professionals, and public warnings about appropriate drug use. Despite concerns about the completeness, objectivity, and timing of drug safety reports, "what we're going to get is going to be better that what we have right now," Woodcock predicted.
Although Sentinel's prime purpose is to serve the FDA's regulatory mission, the long-term vision is that the program will become part of a larger health information system that also provides data for outcomes studies, comparative effectiveness research (CER), and health system quality reporting. Manufacturers support the goal of building such a multipurpose network, said Paul Stang of Johnson & Johnson at the workshop, but this requires more investment in research methods, in standards for data sources and evidence, and in governance of emerging models.
Carolyn Clancy, director of the Agency for Healthcare Research and Quality (AHRQ), concluded the program by describing AHRQ initiatives to build distributed data research networks and to improve patient registries that can answer queries related to the effectiveness and safety of medical services and products. An over-arching goal is to identify synergies between postmarketing surveillance and CER and to provide incentives for healthcare providers to participate in e-health activities.
Jill Wechsler is BioPharm International's Washington editor, Chevy Chase, MD, 301.656.4634, firstname.lastname@example.org