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:

Research Projects

Novel Digital Medical Devices

This series of projects works to ensure proper regulation and safe growth of digital medical devices with specific consideration to generating high-quality evidence, development of AI and LLMs, and digital therapeutic clinical trials.

Postmarket Medical Device Safety Surveillance

This series of projects leverages electronic health records and other real-world data sources to track and evaluate safety events associated with postmarket medical devices.

Clinical Evidence and Communication Unit

This unit works to drive robust evidence generation via objective and measurable assessments of clinical trial evidence, and enhanced communication about drug benefits and harms.

Novel Clinical Trail Designs

Studying the design of trails for novel drugs and devices provides an opportunity to build an understanding of effective trial methodology, and ensure novel offerings are as safe and effective as possible.

Publications

Pediatric Medical Device Development

The System of Hospitals for Innovation in Pediatrics – Medical Devices (SHIP-MD) aims to transform the pediatric medical device ecosystem by accelerating developmental processes to stimulating investment and innovation in pediatric devices.

Publications

Real World Evidence

Leveraging real-world data to generate robust real-world evidence, this research supports FDA regulatory decision-making across the medical product lifecycle, from development and approval through postmarket safety and effectiveness evaluation.

Publications