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Getting the latest healthcare news for you
Getting the latest healthcare news for you
Since the 21st Century Cures Act took effect in 2016, the number of trials supporting FDA novel drug approvals has dropped sharply — from an average of 3.41 studies per approval to just 1.39 by 2024. At the same time, industry funding of those trials surged from 44.6% to 80.4%. Researchers are calling for stronger oversight, better reporting requirements, and more independent research funding.
Since the 21st Century Cures Act was enacted in December 2016 — giving the FDA flexibility to accept a single pivotal trial for novel drug approvals — the evidence base supporting those approvals has thinned considerably. A retrospective analysis published in PLoS One found a steady, linear decline in the average number of trials used per approval, dropping from 3.41 in 2016 to just 1.39 in 2024.
The shift in who's funding those trials is equally striking. Industry sponsorship — from pharma, biotech, and medical device companies — jumped from 44.6% in 2016 to 80.4% by 2024, while NIH and government sources contributed less than 3% of total study funding in most years. Delays in public reporting of trial results also remained a persistent problem, with average posting times exceeding two years in some years.
By the Numbers:
Why it matters: As drug approvals increasingly rest on fewer, industry-funded studies, questions about the rigor and independence of the FDA review process are growing louder. Researchers are urging policymakers to strengthen post-market surveillance, enforce timely trial reporting, and invest in non-industry-funded research to safeguard the integrity of drug approvals.
