Analysis of the Frequency, Characteristics, and Reasons for Termination of Spine-related Clinical Trials.
Journal
Clinical spine surgery
ISSN: 2380-0194
Titre abrégé: Clin Spine Surg
Pays: United States
ID NLM: 101675083
Informations de publication
Date de publication:
01 08 2022
01 08 2022
Historique:
received:
27
09
2021
accepted:
01
03
2022
pubmed:
31
3
2022
medline:
29
7
2022
entrez:
30
3
2022
Statut:
ppublish
Résumé
Cross-sectional analysis of completed and terminated spine-related clinical trials in the ClinicalTrials.gov registry. The aim was to quantify completed and terminated spine-related clinical trials, assess reasons for termination, and determine predictors of termination by comparing characteristics of completed and terminated trials. Clinical trials are key to the advancement of products and procedures related to the spine. Unfortunately, trials may be terminated before completion. ClinicalTrials.gov is a registry and results database maintained by the National Library of Medicine that catalogs trial characteristics and tracks overall recruitment status (eg, ongoing, completed, terminated) for each study as well as reasons for termination. Reasons for trial termination have not been specifically evaluated for spine-related clinical trials. The ClinicalTrials.gov database was queried on July 20, 2021 for all completed and terminated interventional studies registered to date using all available spine-related search terms. Trial characteristics and reason for termination, were abstracted. Univariate and multivariate analyses were performed determine predictors of trial termination. A total of 969 clinical trials were identified and characterized (833 completed, 136 terminated). Insufficient rate of participant accrual was the most frequently reported reason for trial termination, accounting for 33.8% of terminated trials.Multivariate analysis demonstrated increased odds of trial termination for industry-sponsorship [odds ratio (OR)=1.59] relative to sponsorship from local groups, device studies (OR=2.18) relative to investigations of drug or biological product(s), and phase II (OR=3.07) relative to phase III studies ( P <0.05 for each). Spine-related clinical trials were found to be terminated 14% of the time, with insufficient accrual being the most common reason for termination. With significant resources put into clinical studies and the need to advance scientific objectives, predictors, and reasons for trial termination should be considered and optimized to increase the completion rate of trials that are initiated.
Sections du résumé
STUDY DESIGN
Cross-sectional analysis of completed and terminated spine-related clinical trials in the ClinicalTrials.gov registry.
OBJECTIVE
The aim was to quantify completed and terminated spine-related clinical trials, assess reasons for termination, and determine predictors of termination by comparing characteristics of completed and terminated trials.
SUMMARY OF BACKGROUND DATA
Clinical trials are key to the advancement of products and procedures related to the spine. Unfortunately, trials may be terminated before completion. ClinicalTrials.gov is a registry and results database maintained by the National Library of Medicine that catalogs trial characteristics and tracks overall recruitment status (eg, ongoing, completed, terminated) for each study as well as reasons for termination. Reasons for trial termination have not been specifically evaluated for spine-related clinical trials.
METHODS
The ClinicalTrials.gov database was queried on July 20, 2021 for all completed and terminated interventional studies registered to date using all available spine-related search terms. Trial characteristics and reason for termination, were abstracted. Univariate and multivariate analyses were performed determine predictors of trial termination.
RESULTS
A total of 969 clinical trials were identified and characterized (833 completed, 136 terminated). Insufficient rate of participant accrual was the most frequently reported reason for trial termination, accounting for 33.8% of terminated trials.Multivariate analysis demonstrated increased odds of trial termination for industry-sponsorship [odds ratio (OR)=1.59] relative to sponsorship from local groups, device studies (OR=2.18) relative to investigations of drug or biological product(s), and phase II (OR=3.07) relative to phase III studies ( P <0.05 for each).
CONCLUSIONS
Spine-related clinical trials were found to be terminated 14% of the time, with insufficient accrual being the most common reason for termination. With significant resources put into clinical studies and the need to advance scientific objectives, predictors, and reasons for trial termination should be considered and optimized to increase the completion rate of trials that are initiated.
Identifiants
pubmed: 35351841
doi: 10.1097/BSD.0000000000001323
pii: 01933606-202208000-00011
doi:
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
E596-E600Informations de copyright
Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.
Déclaration de conflit d'intérêts
The authors declare no conflict of interest.
Références
ClinicalTrials.gov. About the Results Database. Bethesda, MD: National Library of Medicine (US), National Center for Biomedical Information; 2018. Available at: https://clinicaltrials.gov/ct2/about-site/results . Accessed July 19, 2021.
Food and Drug Administration Amendments Act of 2007. Pub. L. 110–85, Title VIII—Clinical Trial Databases, 121 STAT. 904 (Septmber 27, 2007).
ClinicalTrials.gov Protocol Registration Data Element Definitions for Interventional and Observational Studies. Bethesda, MD: National Library of Medicine (US), National Center for Biomedical Information. 2020. Available at: http://prsinfo.clinicaltrials.gov/definitions.html . Accessed July 20, 2021.
Williams RJ, Tse T, DiPiazza K, et al. Terminated trials in the ClinicalTrials.gov results database: evaluation of availability of primary outcome data and reasons for termination. PLoS One. 2015;10:e0127242.
Ohnmeiss DD. The fate of prospective spine studies registered on www.ClinicalTrials.gov. Spine J. 2015;15:487–491.
Bernardez-Pereira S, Lopes RD, Carrion MJ, et al. Prevalence, characteristics, and predictors of early termination of cardiovascular clinical trials due to low recruitment: insights from the ClinicalTrials.gov registry. Am Heart J. 2014;168:213–219.e1.
Chapman SJ, Shelton B, Mahmood H, et al. Discontinuation and non-publication of surgical randomised controlled trials: observational study. BMJ. 2014;349:g6870.
ClinicalTrials.gov FDAAA 801 and the Final Rule. Bethesda, MD: National Library of Medicine (US), National Center for Biomedical Information. 2020. Available at: https://clinicaltrials.gov/ct2/manage-recs/fdaaa . Accessed July 19, 2021.