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 w...

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Published in:	European journal of cardio-thoracic surgery Vol. 66; no. 2
Main Authors:	Cancelli, Gianmarco, Rossi, Camilla S, Dell'Aquila, Michele, Mantaj, Polina, Hirofuji, Aina, Soletti, Giovanni, Harik, Lamia, Cangut, Busra, Al Zaghari, Talal, Leith, Jordan, Falco, Giorgia, Ibrahim, Mudathir, Dimagli, Arnaldo, Rahouma, Mohamed, Gaudino, Mario F L
Format:	Journal Article
Language:	English
Published:	Germany Oxford University Press 02-08-2024
Subjects:	Cardiac Surgical Procedures - statistics & numerical data Clinical Trials as Topic - statistics & numerical data Databases, Factual Early Termination of Clinical Trials Humans Termination Trials Cardiac surgery
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Summary:	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. Clinical trials measure the safety and effectiveness of an intervention and represent the highest level of evidence in clinical research [1].
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23
ISSN:	1010-7940 1873-734X 1873-734X
DOI:	10.1093/ejcts/ezae310