Abstract
Purpose
Non-publication and premature discontinuation for clinical trials pose an ethical dilemma for trial participants, patients, clinicians, and researchers, as well as the general public as these studies receive significant public funding that may be further contributing to research waste. Here, we investigate the rate of trial discontinuation and non-publication among CRC trials using ClinicalTrials.gov.
Methods
We performed an advanced search on ClinicalTrials.gov pertaining to the treatment of CRC using the keyword colorectal cancer. For each clinical trial, links to the publication provided by ClinicalTrials.gov were searched and verified to be correct. If a publication was unable to be found using the methods above, we attempted to contact the lead investigator via email for the reason for non-publication.
Results
Of the 123 (123/428, 28.7%) discontinued trials, a reason for discontinuation was provided for 57 (57/123, 46.3%) trials. Of the 305 (305/428, 71.3%) completed trials, 244 (244/305, 80.0%) had a verifiable publication, while 61 (61/305, 20.0%) did not publish their findings or were unable to be located.
Conclusion
We found that more than one-quarter of trials were prematurely ended, and almost one-third of completed trials did not publish their findings. Subjecting trial participants to potentially harmful treatments and interventions that fail to complete or publish study findings have the potential to undermine the patient-provider relationship, as well as public confidence in government-sponsored clinical trials.
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Data and materials are available upon reasonable request from the corresponding author.
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Contributions
MV developed the protocol and conceptualized the study. BT, CW, MA, CM, MP, and MV will conduct all literature searches. BT and CW will conduct all statistical analyses. BT, CW, MA, CM, MP, and MV will participate in all writing. BT, CW, MA, CM, MP, and MV are equally the guarantors of the study and the integrity of the data.
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Our manuscript did not meet requirements to undergo IRB consideration, and thus, no documentation can be attached as a supplemental file. This study analyzes data from ClinicalTrials.gov, an online open-access website. IRB exceptions are deemed when appropriate to be reviewed by the IRB for possible human research.
Conflict of interest
Dr. Vassar reports receipt of funding from the National Institute on Drug Abuse, the National Institute on Alcohol Abuse and Alcoholism, the US Office of Research Integrity, Oklahoma Center for Advancement of Science and Technology, and internal grants from Oklahoma State University Center for Health Sciences — all outside of the present work. The remaining authors have nothing to disclose.
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Traxler, B., Walters, C., Adewumi, M.T. et al. An analysis of the rates of discontinuation and non-publication of colorectal cancer clinical trials. Int J Colorectal Dis 36, 2529–2532 (2021). https://doi.org/10.1007/s00384-021-03972-0
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DOI: https://doi.org/10.1007/s00384-021-03972-0