Research at Harvard-MIT CRS

Regulatory Science research conducted at the Center spans a wide range of topics and research disciplines. You can browse some of our work by the focus areas below.


Digital Medicine

Digital Medicine: A Primer on Measurement
Coravos, Andrea, Jennifer C. Goldsack, Daniel R. Karlin, Camille Nebeker, Eric Perakslis, Noah Zimmerman, and M. Kelley Erb. Digital Biomarkers 3, no. 2 (May 9, 2019): 31–71.

Developing and Adopting Safe and Effective Digital Biomarkers to Improve Patient Outcomes
Coravos, Andrea, Sean Khozin, and Kenneth D. Mandl. Npj Digital Medicine 2, no. 1 (March 11, 2019): 14.

Challenges and Opportunities in Software-Driven Medical Devices
Gordon, William J., and Ariel D. Stern. Nature Biomedical Engineering 3, no. 7 (July 2019): 493–97.

Decentralized Trials in the Age of Real-World Evidence and Inclusivity in Clinical Investigations
Khozin, Sean, and Andrea Coravos. Clinical Pharmacology and Therapeutics, April 23, 2019.

How Artificial Intelligence Is Changing Health Care Delivery
Sanders, Samantha F, Terwiesch, Mats, Gordon, William J, and Stern, Ariel S. NEJM Catalyst, October 17, 2019.

Cybersecurity Features of Digital Medical Devices: An Analysis of FDA Product Summaries
Stern, Ariel Dora, William J Gordon, Adam B Landman, and Daniel B Kramer. BMJ Open 9, no. 6 (June 2019): e025374.

The Case for a Hippocratic Oath for Connected Medical Devices: Viewpoint
Woods, Beau, Andrea Coravos, and Joshua David Corman. Journal of Medical Internet Research 21, no. 3 (March 19, 2019): e12568.

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Novel clinical trial designs supporting drug and device approval

Adaptive Platform Trials: Definition, Design, Conduct and Reporting Considerations
Angus, Derek C., Brian M. Alexander, Scott Berry, Meredith Buxton, Roger Lewis, Melissa Paoloni, Steven A. R. Webb, et al. Nature Reviews Drug Discovery, August 28, 2019.

A Systematic Review of Feasibility Studies Promoting the Use of Mobile Technologies in Clinical Research
Bakker, Jessie P., Jennifer C. Goldsack, Michael Clarke, Andrea Coravos, Cynthia Geoghegan, Alan Godfrey, Matthew G. Heasley, et al. Npj Digital Medicine 2, no. 1 (December 2019).

The Central and Unacknowledged Role of the US Food and Drug Administration in the Design and Execution of Medical Device Pivotal Trials
Kaplan, Aaron V., and Ariel D. Stern. JAMA Cardiology 3, no. 1 (January 1, 2018): 5–6.

Decentralized Trials in the Age of Real-World Evidence and Inclusivity in Clinical Investigations
Khozin, Sean, and Andrea Coravos. Clinical Pharmacology and Therapeutics, April 23, 2019.

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Health policies and law in drug regulation

FDA and EMA Biosimilar Approvals
Jung, Emily H., Ameet Sarpatwari, Aaron S. Kesselheim, and Michael S. Sinha. Journal of General Internal Medicine, October 21, 2019.

Experiences With and Challenges Afforded by Expedited Regulatory Pathways
Liu, Sheng, and Aaron S. Kesselheim. Clinical Pharmacology & Therapeutics 105, no. 4 (2019): 795–97.

Is Health-Care Data the New Blood?
Perakslis, Eric, and Andrea Coravos. The Lancet Digital Health 1, no. 1 (May 1, 2019): PE8-E9.

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Real world evidence in the lifecycle approach to product evaluation

Decentralized Trials in the Age of Real-World Evidence and Inclusivity in Clinical Investigations
Khozin, Sean, and Andrea Coravos. Clinical Pharmacology and Therapeutics, April 23, 2019.

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Pediatric drug and device development

Cost Implications of Escalating Intravenous Acetaminophen Use in Children
Bourgeois, Florence T., Dionne A. Graham, Aaron S. Kesselheim, and Adrienne G. Randolph. JAMA Pediatrics, March 11, 2019.

Promoting Pediatric Drug Research and Labeling – Outcomes of Legislation
Bourgeois, Florence T., and Aaron S. Kesselheim. The New England Journal of Medicine 381, no. 9 (29 2019): 875–81.

Impact Of The Priority Review Voucher Program On Drug Development For Rare Pediatric Diseases
Hwang, Thomas J., Florence T. Bourgeois, Jessica M. Franklin, and Aaron S. Kesselheim. Health Affairs (Project Hope) 38, no. 2 (February 2019): 313–19.

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Biomarkers & surrogate markers in drug trials

Innovation Incentives and Biomarkers
Stern, Ariel D., Brian M. Alexander, and Amitabh Chandra. Clinical Pharmacology and Therapeutics 103, no. 1 (January 2018): 34–36.

Digital Medicine: A Primer on Measurement
Coravos, Andrea, Jennifer C. Goldsack, Daniel R. Karlin, Camille Nebeker, Eric Perakslis, Noah Zimmerman, and M. Kelley Erb. Digital Biomarkers 3, no. 2 (May 9, 2019): 31–71.

Developing and Adopting Safe and Effective Digital Biomarkers to Improve Patient Outcomes
Coravos, Andrea, Sean Khozin, and Kenneth D. Mandl. Npj Digital Medicine 2, no. 1 (March 11, 2019): 14.

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