Discontinuation and Nonpublication of Clinical Trials in Orthopaedic Oncology

Abstract

Abstract Background: This study conducted an analysis examining clinical trial discontinuation rates, associations between intervention types and discontinuation/nonpublication, and the role of funding, enrollment size, and their implications for trial success and completion. Methods: We analyzed ClinicalTrials.gov on May 1, 2023, for phase 3 and 4 randomized controlled trials (RCTs) pertaining to orthopaedic oncology. Trial completion status was assessed using publicly available data on ClinicalTrials.gov. Publication status was also assessed on ClinicalTrials.gov, and by utilizing PubMed (MEDLINE, Google Scholar, and Embase). Results: Among the cohort of 130 trials, 19.2% were prematurely discontinued. Completion rates varied based on intervention type; 111 pharmaceutical trials demonstrated a completion rate of 83.8%, whereas 19 non-pharmaceutical trials exhibited a completion rate of 8.0% (P<.001). Surgical trials, totaling 10, showed a completion rate of 90%. The overall trial publication rate was 86.15%, with pharmaceutical interventions achieving a publication rate of 91.96%. Larger-scale trials (≥261 participants) emerged as a protective factor against both discontinuation (Adjusted Odds Ratio [AOR]: 0.85, 95% Confidence Interval [CI]: 0.42–0.95) and nonpublication (AOR: 0.19, 95% CI: 0.13–.47), compared to smaller-scale trials. Conclusion: Our examination of orthopaedic oncology clinical trials underscores the imperative to confront the challenges linked with trial discontinuation and nonpublication. This study accentuates the heightened vulnerability of non-pharmaceutical interventions and trials exhibiting lower rates of enrollment to the issues of discontinuation and nonpublication. Moving forward, the advancement of clinical trials necessitates a concerted effort to enhance trial methodologies, especially concerning nonpharmaceutical interventions, along with a meticulous refinement of participant enrollment criteria.