Rates of Discontinuation and Nonpublication of Head and Neck Cancer Randomized Clinical Trials

This systematic review assesses the rate of discontinuation or nonpublication of phase 3 and 4 randomized clinical trials involving patients with head and neck cancer. Importance Randomized clinical trials (RCTs) play an important role in clinical decision-making, and discontinuation or nonpublication of these trials are causes of great concern. The extent of discontinued or unpublished RCTs about head and neck cancer remains unclear. Objective To assess the rate of discontinuation or nonpublication of RCTs involving patients with head and neck cancer. This objective was measured by observing 3 domains: discontinuation of trial, nonpublication of trial data, and feasibility of contacting trial investigators of aforementioned trials. Evidence Review For this study, the sample was derived using the ClinicalTrials.gov advanced search feature on March 18, 2019, to locate completed and discontinued RCTs pertaining to head and neck cancer registered before this date. Trials were analyzed to identify reasons for trial discontinuation and publication status of each trial. If publication status or reason for trial discontinuation was not allocated through the systematic search of ClinicalTrials.gov, the corresponding author was emailed to determine publication status. Findings After exclusions, 130 RCTs were included. Of these trials, 92 (70.8%) were completed and 38 (29.2%) were discontinued for various reasons. The most common reason for discontinuation of trials was committee recommendations. Of the 130 analyzed trials, 67 (51.5%) were published in a peer-reviewed journal and 63 (48.5%) were unpublished trials. Of the 92 completed trials, 55 (59.8%) were published and 37 (40.2%) remained unpublished 3 or more years after trial completion. Trials funded by other sources (private, nonprofit, or the National Institutes of Health) were more likely to reach publication than industry-funded RCTs (unadjusted odds ratio, 4.3 [95% CI, 1.3-14.0]; adjusted odds ratio, 4.1 [95% CI, 1.2-14.3]). Conclusions and Relevance Of RCTs in head and neck cancer, 29.2% were discontinued and 40.2% completed trials never reached publication. The findings suggest that needs exist for RCT guidance of head and neck cancer. The reporting of reasons for trial discontinuation appears to be lacking, and trial publication rates were low. This study is relevant to many physicians and researchers because it identifies potential sources of decreased research productivity and ethics. Question What are the rates of discontinuation or nonpublication of randomized clinical trials (RCTs) about head and neck cancer, and what are the potential factors associated with trial discontinuation and nonpublication? Findings In this study of 130 RCTs, 92 trials (70.8%) were completed and 38 (29.2%) were discontinued, with committee recommendations as the most common reason for discontinuation of trials. Of the 130 RCTs, 67 (51.3%) were published and 63 (48.5%) were unpublished, with trials funded by other sources more likely to reach publication than industry-funded RCTs. Meaning The rate of discontinuation and nonpublication of RCTs of head and neck cancer appears to be high, which may thwart scientific advancements, dissuade patient participation in trials, and unnecessarily expose patients to unproven and potentially harmful interventions.