Research at the Harvard-MIT Center for Regulatory Science
The Center supports a wide range of research activities focused on strategic approaches to advancing the process of developing and evaluating drugs and other medical products. Our faculty and fellows engage in cross-disciplinary collaborations with scientists in regulatory agencies, pharmaceutical companies, and other academic institutions to produce cutting-edge research across a number of scientific disciplines, including:
Working closely with the FDA, the Center supports research projects defining the emerging digital medicine landscape, convening key stakeholders to tackle regulatory challenges in assessing digital products and how to integrate these into patient care.Publications
Pediatric Drugs and Devices
Unique challenges in the development and evaluation of products for pediatric populations call for innovative approaches in data science to close the pediatric evidence gap.Publications
The Center collaborates with faculty at the Harvard Business School and in the Program On Regulation Therapeutics and Law (PORTAL) to produce analyses of health and regulatory policies and how these shape drug discovery, development, and patient access to innovative products.Publications
Adaptive Platform Trials: Definition, Design, Conduct and Reporting Considerations
Angus, Alexander, Berry, Buxton, Lewis, Paoloni, Webb, et al. 2019.