Alex Berg*, Ryan P. Mayers*, and Sarah Richards*
Edited by Sharon Jiang and Friederike M. C. Benning
Article | Aug. 29 2022
*Emails: alexberg@mit.edu, ryan.mayers@som.umaryland.edu, sarahevrichards@gmail.com
DOI: 10.38105/spr.y9p3sxuqg1
Highlights
- The recent approval of Aduhelm, a medicine indicated for Alzheimer’s disease, sparked controversy in part due to reliance on biomarkers instead of primary data showing cognitive improvement
- The use of biomarker surrogate endpoints enables medicines to make it from bench to bedside faster but reduces the certainty that these medicines show clinical efficacy
- Future policy should build on the lessons from the Aduhelm approval, consider how biomarkers are chosen, and balance the risk of using biomarkers with their potential benefit to patients with neurodegenerative diseases
Article Summary
Open Access

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Alex Berg
Computation and Cognition, Computer Science and Artificial Intelligence Lab of MIT, Cambridge, MA 02139, USA
Ryan P. Mayers
Program in Neuroscience, University of Maryland School of Medicine, Baltimore, MD 21201, USA
Sarah Richards
Chemical Biology and Therapeutics Science, Broad Institute of MIT and Harvard, Cambridge, MA 02138, USA