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It remains unclear whether the US clinical trial ecosystem is optimized to evaluate medical interventions efficiently. This study characterizes interventional clinical trials in the USA and examines trial progress over five years.
Methods:
Using the Aggregate Analysis of ClinicalTrials.gov (AACT) database, we conducted a cross-sectional study of interventional trials initiated in 2023 and a follow-up cohort tracking five-year completion for trials started in 2018 and registered in ClinicalTrials.gov as of 05/01/2024 by sponsor and therapeutic area. Trials with at least one US site were included. Primary outcomes were enrollment, completion status, intervention type, study arm design, and plan to share individual participant data.
Results:
Over 7,500 trials met inclusion criteria for each cohort. Most trials started in 2018 (68.4%) and 2023 (62.5%) enrolled fewer than 100 participants. Median enrollment in 2023 was higher for NIH (90) than industry-sponsored (76) trials. Within five years, 60.5% of the 2018 trials were completed, with higher completion among industry (60.9%) than NIH-sponsored (54.3%) trials. In 2023, industry predominantly funded cancer studies and trials testing drug interventions, whereas the NIH prioritized mental health studies and behavioral interventions. More than one-quarter of trials used a single-group design, 72.0% did not plan to share participant-level data, and 72.6% of drug trials were early phase.
Conclusion:
Many clinical trials are small, lack a control group, and are incomplete within five years, with differences by sponsor. Given the urgent need to improve health through rigorous evidence generation, there are likely opportunities to improve the US clinical trial ecosystem.
Timely dissemination of clinical trial results is essential to advance knowledge, guide practice, and improve outcomes, yet many trials remain unpublished, limiting impact. We examine what drives publication and timelines across three major clinical domains.
Methods:
We analyzed study design and factors associated with dissemination of interventional trials, focusing on cardiovascular disease (CVD), cancer, and COVID-19. A total of 10,785 trials (CVD: 5929; cancer: 4210; COVID-19: 646) were linked to PubMed publications using National Clinical Trial identifiers. Study design, operational, and transparency-related features were assessed as predictors of time to publication, defined as the interval from study completion to first publication, using Cox proportional hazards model.
Results:
COVID-19 trials had the highest publication rate (49.6%), followed by CVD (42.3%) and cancer (32.9%), likely reflecting pandemic-related prioritization. Faster publication was associated with larger enrollment, more sites, result posting, randomization, DMC presence, and higher blinding levels (all p < 0.05). Slower publication was linked to supportive care or diagnostic trials (CVD), basic science (cancer), and later COVID-19 trial completion. In subgroups, U.S. facility presence (CVD) and phase 3 design (cancer) predicted faster publication, while healthy volunteer inclusion (CVD) predicted slower publication. Among DMC trials, more secondary outcomes were linked to faster publication across all disease areas.
Conclusions:
Key study design and operational factors consistently predict whether and when trials are published. Strengthening methodological rigor, result reporting, and multi-site collaboration may accelerate timely dissemination into peer-reviewed literature.
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