ArticlePloS one2026
Changes in evidence used for FDA Novel Drug Approvals: 2016-2024.
Article in PloS one, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe 21st Century Cures Act (2017) was enacted during a period of evolving FDA flexibility in evidentiary standards for drug approval. To examine trends before and after implementation, we independently reviewed all novel drugs approved between 2016 and 2024.
methodsWe constructed a database of all novel FDA approvals from January 1, 2016, through December 31, 2024. Each study linked to an approved drug (N = 6,763) was cataloged by study number, sponsorship, and timing of results reporting relative to completion.
resultsSince 2016, the number of studies supporting approval has steadily declined. Beginning in 2017, the modal number of studies per approval fell to one. Industry sponsorship increased while NIH-supported studies decreased. Average time to public posting of results exceeded the one-year statutory limit.
conclusionsIn the post-2016 period, FDA approvals were supported by fewer studies and by a greater proportion of industry-sponsored studies. Although this may accelerate access to new therapies, it raises concerns about the strength of evidence for safety and effectiveness.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.