Study: Funding Source Impacts Trial Completion
Investigators for the study, from Cedars-Sinai and Johns Hopkins University in Baltimore, said that understanding how these differences affect study results could help guide future funding decisions to ensure maximum efficacy in the lab and the clinic.
ClinicalTrials.gov is a widely used, web-based resource that provides information about publicly and privately supported clinical studies involving human subjects in the U.S. and around the world. The site is maintained by the National Library of Medicine of the National Institutes of Health (NIH).
"Little is known about the characteristics and trends in clinical trials over time and how they differ by sponsor type," said Gillian Gresham, PhD, acting assistant professor of Medicine at the Cedars-Sinai Research Center for Health Equity at the Samuel Oschin Comprehensive Cancer Institute. She was the corresponding author of the study, recently published by the journal JAMA Network Open.
To learn more, scientists performed a cross-sectional study of 245,999 U.S.-based trials registered on ClinicalTrials.gov from Jan. 1, 2000, through Dec. 31, 2019.
They grouped the trials by the lead sponsor: NIH or other U.S. governmental agencies; industry; and other sources such as foundations, universities, hospitals and clinics. For each group, they tracked trends in overall status, phase, intervention, number of sites, use of study procedures such as masking and randomization, sample size and time-to-study completion by start year.
The study found that 54.9% of the clinical trials were completed. Among completed trials, 3.8% were sponsored by the NIH or other U.S. government agency, 36% by industry and 60.2% by other funding sources.
Most trials were single-center, randomized and either Phase 1 or 2 or undefined-phase studies. Median completion times varied by the lead sponsor, from 3.4 years for U.S. government-sponsored trials to 1.2 years for industry-sponsored trials. Over time ,the median sample sizes and years to trial completion decreased.The analysis showed that U.S.-based trials sponsored by industry had a higher median completion rate than other types and were completed at faster rates compared with trials sponsored by the U.S. government. In addition, the number of industry-sponsored trials started by year increased nearly four-fold during the 20-year period while completion rates decreased. Trial sample sizes remain small with an overall sample size of 60 persons per trial, which diminished in number over time.
In view of these findings, Gresham said, "increased funding of larger, randomized clinical trials may be warranted to inform clinical decision-making and guide future research." The findings also suggest that, while, registration and reporting systems could be further improved, they are valuable resources that allow providers, researchers, patients and the public, to access, download and analyze clinical trials data.
The senior author of the study was Curtis Meinert, PhD, at Johns Hopkins University. The co-authors included Jill Meinert and Arthur Gresham at Johns Hopkins University.