The current system for post-marketing surveillance is inadequate because drug manufacturers are largely responsible for collecting, evaluating, and reporting data from post-marketing studies of their own products, according to Dr Frank Douglas, Executive Director of the Massachusetts Institute of Technology’s Center for Biomedical Innovation. Aside from the potential conflict of interest inherent in this model, it is known that less than half of the commitments made to the US Food and Drug Administration for post-marketing studies by manufacturers have been completed and many have not even been initiated, he told PharmaTimes Clinical.
A second major issue is the reliance on spontaneous reporting systems, for example, the Veterans Affairs’ Adverse Drug Event Database and Allergy Reaction Tracking Package, and the Food and Drug Administration’s Adverse Event Reporting System for collection of adverse event data. These programs rely on the voluntary reporting of adverse events by physicians and other healthcare professionals, explains Dr Douglas, adding that there is poor quality of submitted reports, often with inadequate documentation and detail.
No true measure of risk
All of this leads to the underreporting of adverse outcomes with only a small fraction of adverse events that actually occur being captured, he added. So the practical use of this information for the early identification of safety issues is not feasible because of the low rate of event capture, as well as incomplete information about the total treated population, Dr Douglas stressed to PharmaTimes Clinical. Thus the reporting rate is not a true measure of the rate or the risk of a product.
Under its new partnership with the US Food and Drug Administration to speed up the identification of drug safety issues, announced earlier this week, the Massachusetts Institute of Technology’s CBI will work to identify alternative methods for monitoring the safety and efficacy of new and well-established pharmaceutical products and medical devices. The project builds on the work of biosurveillance and automated outbreak detection at the Children’s Hospital Informatics Program at the Harvard-MIT Division of Health Sciences and Technology, which has been under development since 1998 to provide early identification of an anthrax bioterrorist attack.
Over the past seven years, the CHIP has led local and national efforts to apply informatics to automate and improve a previously manual disease reporting and analytic process. Now, under the CBI’s FDA project, CHIP investigators will work to apply informatics to help develop systematic, data-driven approaches to the post-marketing surveillance of drugs.
A model system
AEGIS (the Automated Epidemiologic Geotemporal Integrated Surveillance System) – a pioneering biosurveillance system developed with the National Institutes of Health and the Centres for Disease Control, and others – will serve as a model of real time disease surveillance. Population health is tracked in real-time by leveraging clinical data, which is collected in the routine practice of internal medicine, paediatric, and emergency care, and the fully-automated system is capable of detecting clusters of disease cases that could be suggestive of an outbreak. This has led to remarkably powerful conclusions with practical, critical public health implications for the prevention and detection of influenza on a national level, adds Dr Douglas.
The CBI project will expand the available database sources to build its model, using large healthcare datasets from hospitals and other healthcare sources to recognise patterns that indicate unexpected efficacy or problems with safety for both marketed and pipeline drugs, Dr Douglas concluded.
“The group plans to leverage what we have learned from biosurveillance methods 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,” added Scott Gottlieb, the FDA’s deputy commissioner for medical and scientific affairs.
