ArticleCommunications medicine2025
Longitudinal clinical trial enrollment trends across 341 US FDA-approved drugs and their guiding role in precision medicine strategies.
Article in Communications medicine, 2025. 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
2 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundHealthcare continues to suffer from a one-size-fits-all, trial-and-error model. Precision medicine seeks individualized care but requires clinical trial cohorts that mirror patient populations to detect differences in treatment response. Systematic assessments of trial cohort representativeness remain sparse; most studies are narrow. This study evaluates whether recent efforts, including the US FDA's Drug Trial Snapshots Program, have improved demographic representation in pivotal trials across disease areas.
methodsWe analyzed Drug Trial Snapshots Program data covering 341 Phase III clinical trials supporting drug approvals between 2017 and 2023. We compared enrollment of Asian, Black, Hispanic, and White participants with US Census data using chi-squared tests; assessed trends with regression; and examined patterns by disease area, regulatory designation, and US recruitment.
resultsHere, we show that only 6% of pivotal clinical trials achieve enrollment aligned with the distribution of the four largest racial and ethnic groups in the US population. Enrollment of Black and Hispanic participants decreases over time, whereas that of Asian and White participants increases and remains stable, respectively. Trials based in the US include more Black participants, while trials with Breakthrough Therapy designation (which expedites development and review of drugs for serious or life-threatening conditions) show more balanced enrollment across groups.
conclusionsPersistent imbalances in trial enrollment limit the delivery of precision medicine. Trial location and regulatory designations influence who is included. Earlier planning of trials and more strategic site selection improve the potential for future treatments to serve individuals from all racial and ethnic groups.
Identifiers
What Socratic holds
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 Socratic graph.