Clinical trials are crucial for the development of spine-related products and procedures. Sadly, trials occasionally end before they are fully completed. Trial characteristics are listed in the ClinicalTrials.gov registry and results database of the National Library of Medicine, which also keeps track of each study’s general recruitment status (such as ongoing, completed, or terminated) and termination reasons. The causes of trial termination in clinical trials involving the spine have not been specifically examined. All spine-related search terms were used to search the ClinicalTrials.gov database on July 20, 2021, to identify all completed and terminated interventional studies that had been registered up to that point. The characteristics of the abstracted trial and the reason for termination were used. Both univariate and multivariate analyses were used to find the trial termination predictors. In total, 969 clinical trials were found and described (833 completed, 136 terminated). With 33.8% of trials ending prematurely due to insufficient participant accrual, this was the most frequently cited reason for trial termination. According to a multivariate analysis, industry sponsorship was associated with higher odds of trial termination than local group sponsorship (odds ratio (OR)=1.59), device studies were associated with higher odds of trial termination than drug or biological product investigations (OR=2.18), and phase II studies were associated with higher odds of trial termination than phase III studies (P<0.05 for each). Clinical trials involving the spine were found to be discontinued in 14% of cases, with insufficient accrual accounting for the majority of these cases. Predictors and reasons for trial termination should be considered and optimized to increase the completion rate of trials initiated, given the significant resources invested in clinical studies and the need to advance scientific objectives.

Source- journals.lww.com/jspinaldisorders/Abstract/2022/08000/Analysis_of_the_Frequency,_Characteristics,_and.11.aspx