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The MIT Center for Biomedical Innovation has agreed to work with the U.S. Food and Drug Administration to develop ways to monitor the safety of drugs that are already on the market.
Currently, the FDA relies on voluntary reporting to track the adverse effects of drugs. The Center for Biomedical Innovation (CBI) will work to identify alternative ways to monitor the safety and efficacy of new and well-established pharmaceutical products and medical devices.
In addition to voluntary reports the FDA receives from patients and the health-care community, CBI will use large sets of health-care data to recognize patterns that indicate unexpected efficacy or problems with safety.
"Over the past year FDA has introduced several new policy and regulatory initiatives to improve post-marketing surveillance and strengthen the agency's oversight and protection of patients," said Dr. Scott Gottlieb, deputy commissioner for medical and scientific affairs. "This new partnership seeks to greatly enhance the ability of the FDA and the pharmaceutical industry to quickly determine the safety, efficacy or optimal use of a product."
CBI's approach to post-marketing surveillance will be based on advanced methods that automate the process of recognizing unusual patterns of infectious disease. Such systems, developed by the researchers who will take part in this project, are now key tools used by public health departments and the Centers for Disease Control in the fight against bioterrorism and pandemic influenza.
"With recent advances in bioinformation sciences, it is possible to mine and analyze large sets of data to make more rapid post-market identification of safety issues that could not be identified during clinical trials," said Dr. Janet Woodcock, the FDA's deputy commissioner for operations.
The principal investigator on the project, Dr. Kenneth D. Mandl, is a faculty member at CBI and at the Harvard Medical School Center for Biomedical Informatics, and is an attending physician in pediatric emergency medicine at Children's Hospital Boston.
"In addition to identifying the adverse drug effects, our data seeks to help identify expected and unexpected efficacies of products," Mandl said. "We'll be taking methods from biosurveillance developed over the past eight years to help detect outbreaks and track influenza and SARS and applying them to the problem of post-marketing surveillance. The drug safety challenge has striking parallels to the work we have already done."