Abstract
ClinicalTrials.gov is a valuable resource that can be used to trace the state and nature of trials. Since its launch in 2000, more than 345 000 trials have been registered. Little is known about the characteristics and trends in clinical trials over time and how they differ by sponsor type. To assess trends in clinical trials registered in ClinicalTrials.gov over time and by sponsor type. This cross-sectional study included clinical trials (interventional studies) registered in ClinicalTrials.gov from January 1, 2000, through December 31, 2019. The trials were grouped by lead sponsor: National Institutes of Health (NIH) and other US government agencies, industry, and other sources (foundations, universities, hospitals, clinics, and others). A static version of the Clinical Trials Transformation Initiative Aggregate Analysis of ClinicalTrials.gov database was downloaded on January 1, 2020, for analysis. ClinicalTrials.gov registration fields, including overall status, phase, intervention, number of sites, use of masking and randomization, sample size, and time to study completion by start year and lead sponsor (organization that provided funding or support for a clinical study). A total of 245 999 clinical trials (interventional studies) were started between 2000 and 2019, of which 135 144 (54.9%) were completed. Among completed trials, 5113 (3.8%) were sponsored by the NIH or a US government agency, 48 668 (36.0%) by industry, and 81 363 (60.2%) by other sources. Most trials were single center (61.3%), randomized (65.6%), and phase 1 to 2 (35.5%) or did not have a US Food and Drug Administration-defined phase (38.4%), with fewer drug trials being conducted over time. Sample sizes were small (median, 60; interquartile range [IQR], 30-160) and diminished over time. Trial median completion times varied by lead sponsor: 3.4 years (IQR, 1.9-5.0 years) for NIH- and US government-sponsored trials, 1.2 years (IQR, 0.5-2.4 years) for industry trials, and 2.1 years (IQR, 1.1-3.7) for trials sponsored by other sources. The findings suggest that the composition and design of trials changed from 2000 to 2019 and differed substantially by sponsor type. Increased funding toward larger randomized clinical trials may be warranted to inform clinical decision-making and guide future research.
Highlights
Since ClinicalTrials.gov was launched in 2000, more than 345 000 interventional and observational studies have been registered.[1,2,3] ClinicalTrials.gov is managed by the National Library of Medicine and is an online resource for health care professionals, researchers, patients, and the general public
Trial median completion times varied by lead sponsor: 3.4 years (IQR, 1.9-5.0 years) for National Institutes of Health (NIH)- and US government–sponsored trials, 1.2 years (IQR, 0.5-2.4 years) for industry trials, and 2.1 years (IQR, 1.1-3.7) for trials sponsored by other sources
The Final Rule became effective in January 2017, further clarifying and expanding on the registration and requirements of FDAAA 801.8 Some changes include the types of trials subject to the requirements, the information that must be submitted and data elements that are required to be entered on registration, and additional results information reporting requirements for trials.[8]
Summary
Since ClinicalTrials.gov was launched in 2000, more than 345 000 interventional and observational studies have been registered.[1,2,3] ClinicalTrials.gov is managed by the National Library of Medicine and is an online resource for health care professionals, researchers, patients, and the general public. Analyzing clinical trials metadata can illuminate important trends over time, such as the composition, size, design, and types of trials being funded. There have been updates to the clinical trials registration and reporting requirements since implementation of the US Food and Drug Administration (FDA) Modernization Act of 1997, which mandated clinical trials registration and led to the establishment of ClinicalTrials.gov.[4,5] In 2005, the International Committee of Medical Journal Editors (ICMJE) required registration of clinical trials as a prerequisite for publication.[6] Subsequently, the FDA Act (FDAAA 801) of 2007 expanded requirements to the types of trials being registered, key data elements being entered, and basic results being reported.[7] The Final Rule became effective in January 2017, further clarifying and expanding on the registration and requirements of FDAAA 801.8 Some changes include the types of trials subject to the requirements, the information that must be submitted and data elements that are required to be entered on registration, and additional results information reporting requirements for trials.[8] Simultaneously, a policy was issued by the National Institutes of Health (NIH) to require registration and results reporting for all trials funded by the NIH regardless of whether the trials are covered by the FDAAA 801 requirements of the Final Rule.[8]
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