While much of the focus on surrogate endpoint use has been in industry-sponsored research, far less is known about their use in publicly funded trials. (2/7)
By including secondary endpoints, this study provides a more comprehensive view of outcome selection in NIH-funded research. (5/7)
In our new publication in Clinical Trials, we analyzed NIH-sponsored interventional studies from 2006-2024 and characterized both primary and secondary efficacy endpoints. (3/7)
Surrogate endpoints are widely used in clinical trials because they can make studies faster and more cost-effective. However, these indirect measures do not always capture clinically significant outcomes that reflect how patients feel, function, or survive (1/7)
This team was comprised of Icahn School of Medicine at Mount Sinai student Ayman Mohammad, @yaleschoolofmed.bsky.social student Samuel Yoon, @emoryrollins.bsky.social Joshua Wallach & CRRIT Co-Directors @reshmagar.bsky.social & @jsross119.bsky.social
Read more: journals.sagepub.com/doi/10.1177/...
We found that over half of trials used at least one surrogate marker, with high utilization in drug and biologic studies (>75%), and no clear trend over time. These findings highlight the high prevalence of surrogate endpoints in federally funded trials. (4/7)
Given the NIH’s central role in shaping scientific norms, characterizing endpoint selection is key to evaluating whether clinical trial evidence aligns with clinically meaningful outcomes for patients. (6/7)
