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# Scant Evidence for Accelerated Approval Markers: Study
- URL: https://www.fdaweb.com/scant-evidence-for-accelerated-approval-markers-study/
- Published: 2024-05-30T12:00:00.000Z
- Updated: 2026-09-14T14:32:10.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5157084

Researchers at Yale and Emory Universities say there is little evidence that surrogate markers used by drug companies seeking accelerated approval coincide with better disease outcomes. The [study](https://jamanetwork.com/journals/jama/article-abstract/2817850?ref=fdaweb.com) (subscription or purchase required), published recently in the *Journal of the American Medical Association*, looked for meta-analyses for 37 surrogate markers for 32 different chronic non-oncological diseases. The researchers say they concentrated on non-oncological drugs because earlier research looked at oncology drugs and found the same result.

In a statement issued by Yale University, lead author **Joseph Ross**, a professor of medicine there, [says](https://medicine.yale.edu/news-article/fda-use-of-proxies-to-expedite-drug-approvals-not-supported-by-evidence-analysis-finds/?ref=fdaweb.com) “there was a real paucity of evidence” that the surrogates are valid markers of a good disease outcome. “Even though FDA has indicated the level of evidence needed to support use of a surrogate and feel good about its reliability,” he added, “we weren’t able to find that evidence.”

According to Ross, the researchers found there were no published meta-analyses for 60% of the surrogate markers studied. And, he says, for most of the remaining 40% where meta-analyses did exist, the strength of association between the markers and disease outcomes was weak.

The study authors suggest that FDA could increase transparency around the evidence supporting the list of surrogate markers so that doctors and their patients would have more information on which to base treatment choices.

“These findings do not imply that the drugs whose approval was based on use of a surrogate marker don’t work,” the Yale statement says. “But these findings add a level of uncertainty to treatment choices that can be frustrating for patients, especially if medications are expensive or have burdensome side effects.”

At present, Ross said, the only solution is for doctors to be as open as possible with their patients about the existing evidence, or lack thereof.