Sunday, February 6, 2011

Monitoring Drugs for Safety

The drug-approval process is known for its rigorous standards on safety and effectiveness, but even with pre-market clinical trials involving thousands of people, it can’t possibly uncover everything about a drug’s performance that may occur when used by a larger and diverse population.

Presently the FDA’s adverse Event Reporting system relies primarily on voluntary, spontaneous reporting of suspected drug safety issues by health professionals, patients, and consumers. The Observational Medical Outcomes Partnership (OMOP), a public-private partnership was initiated to help improve the monitoring of drugs for safety and to help develop an approach that is systematic, proactive, and cost-effective.

OMOP draws on the expertise and resources of the pharmaceutical industry, academic institutions, non-profit organizations, the FDA, other federal agencies, and is funded and managed through the Foundation for the National Institutes of Health (FNIH).

The goal for OMOP is to use databases with patient medical records and health insurance claims in order to detect and evaluate drug safety issues over time. The partnership is conducting a two year initiative to find feasible and useful methods to use to analyze existing healthcare databases. By using the database information, researchers will be able to identify and evaluate safety and benefit issues of drugs already on the market.

J. Marc Overhage, M.D. PhD, Director of Medical Informatics and Research Scientists at the Regenstrief Institute and Professor of Medical Informatics at Indiana University School of Medicine, speaking as a OMOP Research Investigator, gave a review of the OMOP Experiment at the OMOP Symposium held January 11, 2011.

He explained how a traditional study would conduct an analysis to estimate the association of one drug—one outcome contained in one database—at one point in time. What is envisioned is a national active surveillance system that will be able to do ongoing monitoring of any medical product and any health outcome of interest across all of the databases in the network at any time.

According to Thomas Scarnecchia, Executive Director for FNIH, longer term research plans are to expand OMOP’s methods program to a broader array of medical products to include medical devices, and biologics. The plan is also to expand methods program beyond product safety along with available computational resources.

OMOP is seeking collaborators to work on their 2011 Research Plan. Opportunities are available through FNIH grants, contract project work, and partnerships. For example, on January 12, 2011, OMOP released a “Request for Application” seeking researchers to collaborate on “Methods Research” with OMOP. The procurement is open to any researcher or organization with awards anticipated to be $50,000 to $250,000.

The due date for the RFA is February 14, 2011 with the award date scheduled for February, 28, 2011. For more information on the RFA, email Emily Welebob at For general information on the OMOP program, email Thomas Scarnecchia at