An analysis of the rates of discontinuation and non-publication of colorectal cancer clinical trials.

Abstract

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. 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. 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. 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.