Assessment of trends in the design, accrual, and completion of trials registered in clinicaltrials.gov by sponsor type, 2000-2019

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Assessment of trends in the design, accrual,
and completion of trials registered in
clinicaltrials.gov by sponsor type, 2000-2019

Question:  What are the characteristics and trends of clinical trials registered in ClinicalTrials.gov over time, and how do they differ by sponsor type?

Findings: In this cross-sectional study of ClinicalTrials.gov registration data on 245 999 interventional studies started between 2000 and 2019 that were sponsored by the National Institutes of Health or other US government agencies, industry, or other sources (foundations, universities, hospitals, clinics, and others), most trials were small, single-site studies that did not have US Food and Drug Administration–defined phases and were sponsored by other sources. Median sample sizes and years to trial completion decreased over time.

Meaning: The findings suggest that the composition and design of trials changed between 2000 and 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.

ABSTRACT
Background and Objective:   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. The objective of this study was to assess trends in clinical trials registered in ClinicalTrials.gov over time and by sponsor type.

Design, Setting, and Participants: 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.

Main Outcomes and Measures:   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).

Results:   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.

Conclusions and Relevance: 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.

It may be mentioned here that ever since ClinicalTrials.gov was launched in 2000, more than 345 000 interventional and observational studies have been registered. 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. It is an important resource that can be used to view and access clinical trials registration data.

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