> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Oncologic Surrogates Rarely Correlate with Survival: Study
- URL: https://www.fdaweb.com/oncologic-surrogates-rarely-correlate-with-survival-study/
- Published: 2022-09-28T12:00:00.000Z
- Updated: 2026-09-14T18:01:05.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152839

Researchers at the University of California San Francisco say their review of 15 oncologic drug surrogate outcome analyses published by FDA from 2005 to 2002 found that the vast majority of the analyses did not find strong correlations between a surrogate outcome and overall survival. In fact, they say, of the 15 surrogate analyses conducted by FDA, only one demonstrated a strong correlation between a surrogate outcome and overall survival.

Writing in the *Journal of Cancer Policy*, the researchers [say](https://www.sciencedirect.com/science/article/pii/S2213538322000431?via%3Dihub&ref=fdaweb.com) their findings raise concerns about the use of such outcomes as endpoints in clinical trials. “As most studies were based on limited data,” they add, “further research is required to assess the true validity of surrogate outcomes.”

The study says that drugs approved on the basis of surrogates that are not associated with clinically meaningful outcomes can cause significant harm to patients. “Until surrogate outcomes have been thoroughly and robustly validated,” it says, “they should be used with caution in drug approval decisions.”