Premature termination of interventional ophthalmology clinical trials from international registries
DOI:
https://doi.org/10.18203/2349-3259.ijct20193219Keywords:
Interventional clinical trials, Ophthalmology, Trial terminationAbstract
Globally, a multitude of interventional clinical trials are terminated prior to completion. We sought to identify and analyze trends related to the reporting of these trial results. We conducted a retrospective, cross-sectional study of interventional clinical trials in the 16 primary registries of the World Health Organization Network as well as ClinicalTrials.gov dating back to 2003. A total of 250 studies were identified, of which 135 (54%) were sponsored by academic institutions. A staggering 244 trials (98%) did not lead to publication of results. In sum, a total of 22,420 patients participated in clinical research from which the results were not widely disseminated. 75% of trials were discontinued for unspecified or unclear reasons; 10% were terminated due to inadequate patient accrual. New policies and initiatives have helped usher in an era of improved methods for trial reporting and, in turn, provided the opportunity to perform more interventional trials. However, further action is needed to ensure that findings of all trials are shared with the ophthalmic community in order to build a more comprehensive body of knowledge and decrease potential redundancy.
References
Piuzzi N, Chughtai M, Khlopas A, Gwam CU, Muschler G, Spindler KP, et al. Early Termination of Randomized Clinical Trials in Orthopaedics. Surg Technol Int. 2017;30:290-4.
Baldi I, Lanera C, Berchialla P, Gregori D. Early termination of cardiovascular trials as a consequence of poor accrual: analysis of ClinicalTrials.gov 2006–2015. BMJ Open. 2017;7(6):e013482.
Pak TR, Rodriguez MD, Roth FP. Why clinical trials are terminated. BioRxiv. 2015.
Williams RJ, Tse T, DiPiazza K, Zarin DA. Terminated Trials in the ClinicalTrials.gov Results Database: Evaluation of Availability of Primary Outcome Data and Reasons for Termination. PLoS One. 2015;10(5):e0127242.
Lievre M, Menard J, Bruckert E, Cogneau J, Delahaye F, Giral P, et al. Premature discontinuation of clinical trial for reasons not related to efficacy, safety, or feasibility. BMJ. 2001;322:603-5.
DeAngelis CD, Drazen JM, Frizelle FA, Haug C, Hoey J, Horton R, et al. Clinical trial registration: a statement from the International Committee of Medical Journal Editors. JAMA. 2004;292(11):1363-4.
Yilmaz T, Jutten RJ, Santos CY, Hernandez KA, Snyder PJ. Discontinuation and nonpublication of interventional clinical trials conducted in patients with mild cognitive impairment and Alzheimer's disease. Alzheimers Dement (N Y). 2018;4:161-4.
