Publications by Category
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, a full list of publications can also be seen at https://hmcrs.org/research/publications/all-publications/.
Verification, Analytical Validation, and Clinical Validation (V3): The Foundation of Determining Fit-for-Purpose for Biometric Monitoring Technologies (BioMeTs)
Goldsack, Jennifer C., Andrea Coravos, Jessie P. Bakker, Brinnae Bent, Ariel V. Dowling, Cheryl Fitzer-Attas, Alan Godfrey, et al
NPJ Digital Medicine 3 (2020): 55
BioMeT and Algorithm Challenges: A Proposed Digital Standardized Evaluation Framework
Godfrey, Alan, Jennifer C. Goldsack, Pamela Tenaerts, Andrea Coravos, Clara Aranda, Azid Hussain, Marcos E. Barreto, Fraser Young, and Rodrigo Vitorio.
IEEE Journal of Translational Engineering in Health and Medicine 8 (2020): 0700108.
Novel clinical trial designs supporting drug and device approval
Pathological Complete Response after Neoadjuvant Chemotherapy and Impact on Breast Cancer Recurrence and Survival: A Comprehensive Meta-Analysis
Spring, Laura M., Geoffrey Fell, Andrea Arfe, Chandni Sharma, Rachel Adams Greenup, Kerry L. Reynolds, Barbara L. Smith, et al
Clinical Cancer Research: An Official Journal of the American Association for Cancer Research, February 11, 2020
Health policies and law in drug regulation
A Qualitative Study of Biosimilar Manufacturer and Regulator Perceptions on Intellectual Property and Abbreviated Approval Pathways
Druedahl, Louise C., Anna Birna Almarsdóttir, Sofia Kälvemark Sporrong, Marie Louise De Bruin, Hans Hoogland, Timo Minssen, Marco van de Weert, Aaron S. Kesselheim, and Ameet Sarpatwari
Nature Biotechnology 38, no. 11 (2020): 1253–56
Decision Making Under Uncertainty: Comparing Regulatory and Health Technology Assessment Reviews of Medicines in the United States and Europe
Vreman, Rick A., Huseyin Naci, Wim G. Goettsch, Aukje K. Mantel-Teeuwisse, Sebastian G. Schneeweiss, Hubert G. M. Leufkens, and Aaron S. Kesselheim
Clinical Pharmacology and Therapeutics 108, no. 2 (August 2020): 350–57
Real world evidence in the lifecycle approach to product evaluation
Dynamic Dossier in the Cloud: A Sociotechnical Architecture for a Real-Time and Metrics-Based Data Tracking System with Gene and Cell Therapies as a Case Study
Nam, Kevin, Kay Larholt, Gigi Hirsch, Paul Beninger, David Fritsche, Diane Shoda, John Ferguson, et al
Therapeutic Innovation & Regulatory Science, October 28, 2020