Predictors of premature termination of cardiac surgery trials: insights from the Clinicaltrial.gov database.

ABSTRACT

OBJECTIVES: Clinical trials that are terminated prematurely may generate incomplete and potentially biased data and the reasons for premature trials termination are poorly understood. Our objective was to describe the incidence of premature trial termination and identify factors associated with it. METHODS: We performed a systematic search on ClinicalTrials.gov to identify all cardiac surgery trials from 1991 to 2023. Trials that were terminated prematurely were identified. Factors independently associated with premature termination were identified using multivariable logistic regression analysis. RESULTS: A total of 746 clinical trials were included; of them 577 were completed and 169 (22.6%) were terminated prematurely. Most of the trials originated from North America [294 (39.4%)], Europe [264 (35.4%)] or Asia [141 (18.9%)]. Fourteen of the trials terminated prematurely (8.3%) were phase 1, 75 (44.4%) phase 2, 49 (29.0%) phase 3 and 31 (18.3%) phase 4. Fifty (29.6%) trials were terminated because of slow recruitment, 20 (11.8%) because of sponsor decision and 12 (7.1%) because of lack of funding. Left ventricular assist device trials [odds ratio (OR) 3.65, 95% confidence interval (CI) (1.65-8.00) P = 0.001], valve surgery trials [OR 4.30, 95% CI (2.33-8.00) P < 0.001], aortic surgery trials [OR 2.86 95% CI (1.22-6.43) P = 0.012], phase 2 [OR 3.02, 95% CI (1.31-7.93) P = 0.015] and phase 4 trials [OR 3.62, 95% CI (1.43-10.23) P = 0.010] were at higher risk of premature termination while trials performed in Asia [OR 0.18, 95% CI (0.07-0.39) P ≤ 0.001] and Europe [OR 0.49, 95% CI (0.30-0.80) P = 0.004] were less likely to be terminated prematurely. CONCLUSIONS: Slow recruitment is the most common reason for premature termination of cardiac surgery trials. Trials on left ventricular assist device, valve surgery, aortic surgery, phase 2 trials and phase 4 trials are more likely to be terminated, while trials conducted in Asia and Europe are less likely to be terminated prematurely.