Clinical Trial Quality Assessment in Adult Spinal Surgery: What Do Publication Status, Funding Source, and Result Reporting Tell Us?

Abstract

Study Design Narrative Review Objectives The objective of this study was to compare publication status of clinical trials in adult spine surgery registered on ClinicalTrials.gov by funding source as well as to identify other trends in clinical trials in adult spine surgery. Methods All prospective, comparative, therapeutic (intervention-based) trials of adult spinal disease that were registered on ClinicalTrials.gov with a start date of January 1, 2000 and completion date before December 17, 2018 were included. Primary outcome was publication status of published or unpublished. A bivariate analysis was used to compare publication status to funding source of industry vs non-industry. Results Our search identified 107 clinical trials. The most common source of funding was industry (62 trials, 57.9% of total), followed by University funding (26 trials, 24.3%). The results of 76 trials (71.0%) were published, with industry-funded trials less likely to be published compared to non–industry-funded trials (62.9% compared to 82.2%, P = .03). Of the 31 unpublished studies, 13 did not report any results on ClinicalTrials.gov , and of those with reported results, none was a positive trial. Conclusions Clinician researchers in adult spine surgery should be aware that industry-funded trials are less likely to go on to publication compared to non–industry-funded trials, and that negative trials are frequently not published. Future opportunities include improvement in result reporting and in publishing negative studies.

Why clinical trials in disc regeneration strive to achieve completion: Insights from publication status and funding sources

“…Among these studies, 71% included fewer than 25 patients, 43–45,48,49 57% were characterized by a single‐arm, open‐label, and unblinded design, 44,45,48,49 with one study 45 having enrolled only 15% of the initially estimated population, therefore collectively providing a considerably low level of evidence. Previous investigations have shown that private‐ and industry‐funded trials in spine research were less likely to be published 12,50 . In our study, we did not find any statistical difference in terms of publication status among trials sponsored by universities and private companies.…”

“…Previous investigations have shown that private-and industry-funded trials in spine research were less likely to be published. 12,50 In our study, we did not find any statistical difference in terms of publication status among trials sponsored by universities and private companies.…”

“…Our data also displayed that the rate of registered trials not achieving publication was alarmingly high (73%), even when compared with publication rates of clinical trials related to orthopedic trauma (43%), 51 biologics for cartilage repair and osteoarthritis (44%), 52 and adult spine surgery (21%). 50 Nonetheless, it is noteworthy that 19.2% of the trials included in the analysis were flagged as completed but lacked any reported results, potentially indicating a concern for publication bias. Indeed, it is widely known that studies with positive outcomes have a higher chance of being published compared with negative studies.…”

Response to Letter to the Editor on “Hybrid Anterior Cervical Discectomy and Fusion and Cervical Disc Arthroplasty: An Analysis of Short-Term Complications, Reoperations, and Readmissions”

“…will have to be answered through prospective, randomized control trials. Unfortunately, there is a dearth of high-quality clinical trials performed thus far in the United States; 7 however, work from your group as well as our other clinician/scientist colleagues in spine surgery will undoubtedly lead the way toward safely improving and optimizing patient outcomes.…”