Harvard-MIT CRS responds to the COVID-19 Pandemic
READ MORE
Improving the Process of Therapeutic Development
Harvard, MIT, and the FDA have partnered to create a center focused on regulatory science, bringing together a range of scientific disciplines that are applied to assess the quality, safety and efficacy of medicinal products and inform regulatory decision-making throughout the lifecycle of a medicine. Working across academia, industry, and government institutions, the Center promotes regulatory science through research and education programs, uniting stakeholders under a common mission: promoting optimal patient health outcomes through biomedical innovation and the availability of safe and effective diagnostics and treatments.
Featured Publications
The Regulatory Science Fellowship Program
Our fellowship program is affiliated with the FDA and focuses on training the next generation of regulatory science researchers. Learn more about the research our fellows are conducting or explore opportunities and how to get involved in our program.
News, Events, & Updates
Regulatory Science Forum: Fellows Showcase
Jan 24, 12pm-1:30pm
Harvard Medical School, Armenise 108
Twitter @Harvardmit_CRS
Featuring insights from @PanFabBoston member and @MIT_HST doctoral candidate Avilash Cramer (via @NPR @mgodoyh) https://twitter.com/NPR/status/1278531618697871361
So you want to wear a face mask? Good call.
Experts say there are 3 important factors to consider: fabric, fit and breathability.
Here are the types that offer the most protection 👇
https://trib.al/T0PovkB
In @JAADjournals, pilot study from Tram Bui & @ZiziYu15 w/@sara_j_li & others @bwhdermatology @PanFabBoston on facial skin protectants&N95 fit. All can interfere w/mask failure up to 44%. If you want 2 protect skin must repeat fit testing 2 ensure safety https://www.jaad.org/article/S0190-9622(20)31167-1/pdf
Medtech assessor @ElektraLabs is offering free evaluations of COVID-19 biosensors to doctors and researchers https://tcrn.ch/389Ndne via @techcrunch
About to go live at the #FDADataStrategy workshop to discuss:
- digital biomarkers
- decentralized trials
- remote monitoring
and other methods to put novel data to use in service of patients & public health
Join me, @zakkohane, @DrAbernethyFDA and more! http://fda.yorkcast.com/webcast/Play/845caf0190f849258acd638ee9a2dc4b1d
Congrats Andrea! Essential read for #RandomizedClinicalTrial design from @HarvardMIT_CRS fellow! https://twitter.com/ArfeAndrea/status/1276183954375270401
New paper out on @Biometrics_ibs! Joint work with @LorenzoTrippa and @xelamb.
You are planning a RCT with a survival endpoint. Data from a previous trial suggests the proportional hazards assumption will fail. What are you going to do? (1/n)
https://onlinelibrary.wiley.com/doi/10.1111/biom.13315