Rates of Discontinuation and Nonpublication of Hepatocellular Carcinoma Interventional Clinical Trials
摘要
Hepatocellular carcinoma (HCC) is a major global health issue with high mortality rates and limited treatment options. Interventional clinical trials are critical for advancing HCC targeted therapy, yet the issue of research waste weakens scientific progress. This study aims to find out the rates of discontinuation and non-publication of interventional clinical trials related to HCC.
MethodsHCC clinical trials registered on ClinicalTrials.gov, screened on August 12, 2024, were included in this sample. Multivariate logistic regression was performed to determine the association between trial characteristics and outcomes.
ResultsThrough analysis of the 111 trials, the study found that 76 (68.5%) trials were published and 35 (31.5%) were unpublished. Sixty-nine of 80 completed trials (86.25%) were published, and 11 (13.75%) remained unpublished after completion. The most common listed reason for discontinuation was recruitment challenges. Our multivariate analyses revealed statistically significant differences in trial characteristics between published and unpublished trials, particularly with regard to phase IV trials (unadjusted OR = 4.86, 95% CI: 1.21–19.47), phase III trials (unadjusted OR = 6.00, 95% CI: 1.81–19.90) and enrollment size (unadjusted OR = 1.04, 95% CI: 1.02–1.06). Additionally, we found significant differences between completed and discontinued trials in terms of the type of intervention (crude odds ratio, 0.08 [95% CI, 0.01–0.88], phase IV trials (unadjusted OR = 0.16, 95% CI: 0.03–0.79), and enrollment size (unadjusted OR = 0.98, 95% CI: 0.96–0.99). The significant involvement of academic institutions in funding (54.05%) suggests a strong reliance on educational resources, which may be constrained by financial and logistical challenges.
ConclusionImproving the trial design, funding, and reporting practices is essential to advance HCC research and ensure broader accessibility to clinical findings.