Safety Surveillance Research Program
Challenge: Safety surveillance of new drugs is a critically important element of the drug development process. Safety surveillance is designed to detect adverse drug events for new products on the market, thereby limiting exposure of patients to the hazards of new medications. Safety surveillance has come under intense scrutiny due to high-profile lapses in effective detection that reveal the inadequacies of the system, which include:
- Voluntary reporting system that is estimated to capture only 1 to 10% of adverse events
- System is not ideal for distinguishing between adverse events caused by a drug and adverse events caused by the underlying condition for which the drug is indicated
- Product withdrawals lead to increased costs due to product liability and potential loss of efficacious treatments
Approach: An integrated program of research and educational initiatives that leverage the collective knowledge, expertise, and tools available within the CBI community will be used to address safety surveillance challenges. Building on the core strengths of MIT researchers, this research program is focused on improving data extraction, signal generation and detection, benefit-risk assessment and risk communication.
Events
3/13/08: Workshop "Translating Knowledge from Other Industries"
4/8/08: Drug Safety Futures 2020, Working Session #1
6/27/08: Drug Safety Futures 2020, Working Session #2
9/24/08: Drug Safety Futures 2020, Working Session #3
Safety Surveillance Projects
- Data Extraction and Signal Detection: Methodology Pilot Studies
- Drug Safety Futures 2020
- Drug Safety in a Learnig Healthcare System
- Data Sharing / Business Models
- Risk Communication: Evaluating the Response of Specific Physician Groups and Patients to New Benefit/Risk Information in the Post-Market Environment
- Impact of information about anti-depressants on Pediatricians’ prescribing behavior
- Impact of information about hormone therapy in postmenopausal women on Gynecologists’ prescribing behavior
- Statistical Methods in Safety Surveillance
Participating Faculty
- George Apostolakis, PhD, Korea Electric Power Company Professor of Nuclear Science and Engineering and Professor of Engineering Systems, Department of Nuclear Science and Engineering, MIT
- Dimitris Bertsimas, PhD, Boeing Leaders for Manufacturing Professor of Management and Co-Director, Operations Research Center, MIT
- Ernst Berndt, Louis E. Seley Professor of Applied Economics, MIT
- C. Forbes Dewey, Jr., PhD, Professor of Mechanical Engineering, and Biological Engineering, MIT
- Konstantinos Katsikopoulos, PhD, Visiting Scholar, MIT
- Richard Larson, PhD, Mitsui Professor of Engineering Systems and Civil and Environmental Engineering and Director, Center for Engineering Systems Fundamentals, MIT
- Nancy Leveson, Professor of Aeronautics and Astronautics, MIT
- Stuart Madnick, John Norris Maguire Professor of Information Technology; PROductivity from Information Technology, MIT
- Kenneth D. Mandl, MD, MPH, Assistant Professor, Harvard Medical School and Faculty Researcher, Children’s Hospital Informatics Program
- Deborah Nightingale, PhD, Professor of the Practice of Aeronautics and Astronautics and Engineering Systems and Co-Director, Lean Advancement Initiative, MIT
- Nitin Patel, PhD, Visiting Professor of Engineering Systems, MIT
- Kimberly Thompson, ScD, Associate Professor of Risk Analysis and Decision Science, Harvard School of Public Health
- Roy Welsch, PhD, Professor of Statistics and Management Science, MIT
Collaborators
- AEI-Brookings Joint Center for Regulatory Studies
- Amgen
- AstraZeneca
- Bayer Healthcare
- Centers for Disease Control and Prevention
- Food and Drug Administration
- HMS and Harvard Pilgrim Health Care
- Johnson and Johnson
- Novartis
- US Department of Veterans Affairs
- Vertex Pharmaceuticals
Gigi Hirsch, MD, Executive Director, MIT Center for Biomedical Innovation
For more information, please contact Gigi Hirsch at ghirsch@mit.edu.
