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# More Drug Approval Transparency Needed: Studies
- URL: https://www.fdaweb.com/more-drug-approval-transparency-needed-studies/
- Published: 2023-08-24T12:00:00.000Z
- Updated: 2026-09-14T18:52:36.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155174

Two Oregon State University (OSU) studies indicate that FDA is approving more novel pharmaceutical drugs on single clinical trials and with less public disclosure about those trials than was the norm a few years ago. A university [statement](https://today.oregonstate.edu/news/fda-approving-drugs-after-fewer-trials-providing-less-information-public-osu-studies-find?ref=fdaweb.com) says researchers agree it is important to minimize delays in making treatments for diseases such as cancer available to patients, but they say their findings point to a need for greater transparency around how drugs receive approval.

“We’re not saying that cancer drugs need a lot more studies,” says study co-author **Veronica Irvin**, an OSU College of Health associate professor, “just that they should show all the results or trials that are completed. It doesn’t mean they wouldn’t get approved, but it means we’d have a more complete picture.”

The researchers say they focused on the period after the implementation of the 21st Century Cures Act which was approved in 2016 and was intended to accelerate approval of new medicines so patients could gain access to life-saving drugs that would otherwise take years to become available.

As part of the law, the researchers say, FDA relaxed some standards to allow treatments for priority health conditions such as cancer to be approved with fewer supporting studies, and placed less emphasis on randomized clinical trials, allowing drug companies to rely on surrogate markers instead of clinical outcomes in certain cases.

The study authors reviewed FDA approvals for novel drugs from 2017 to 2022 to determine how many trials were used to evaluate each drug before receiving agency approval. They also looked at the availability of trial results on ClinicalTrials.gov.

Of the 37 drugs approved by FDA in 2022, they say, 24 (65%) were approved based on a single study. Four of the 37 drugs (11%) reported three or more studies before approval. About half of the 413 studies available for analysis were classified as randomized clinical trials. Results were posted at ClinicalTrials.gov for 103 of the 413 studies.

When the agency states that it has reviewed drugmakers’ two submitted studies, Irvin says, consumers are missing information about how many other studies were conducted, what those results showed, and why those specific two studies were chosen for evaluation.

“Everything is supposed to be transparent with this FDA process,” she said. “The purpose of ClinicalTrials.gov was to have a way for the non-scientific community to access the trials and their results in a way that people can understand…. We want doctors and patients to be able to see the whole picture.”