Sponsorship of clinical trials related to the spine: Trends over time and comparative analysis of trial characteristics by sponsorship type

Abstract

ABSTRACT: Background: Clinical trials are crucial to advance products and procedures related to the spine. ClinicalTrials.gov is an internet-based registry and results database that catalogs trial characteristics, such as intervention types, phase, randomization, and blinding. Sponsorship trends have not been specifically evaluated for spine-related clinical trials, nor have trial characteristics been compared among spine-related trials sponsored by institutions, industries, and federal agencies. The purpose of this cross-sectional analysis of spine-related clinical trials was to characterize the types and trends of sponsorship for spine-related clinical trials, and compare trial characteristics among trials sponsored by institutions, industries, and federal agencies. Methods: ClinicalTrials.gov was queried for clinical trials started from the launch of ClinicalTrials.gov (February 29, 2000) through December 31, 2022, using the term “spine.” Trial characteristics were abstracted, including start year, intervention type, phase, randomization, and blinding. Univariate and multivariate analyses were performed to determine associations between sponsorship type and other trial characteristics. Results: A total of 4,484 clinical trials were identified, of which 78 trials were excluded due to incomplete reporting of trial registration data. From 2000 through 2022, the number of spine-related trials initiated annually markedly increased (from 21 to 453, representing an increase of 2,057%). This was predominantly driven by an increase in the number of institutionally sponsored trials. Relative to trials with institutional sponsorship, industry sponsorship was independently associated with different intervention types, phases of study, lack of randomization, and lack of blinding. Relative to trials with institutional sponsorship, federal sponsorship was independently associated with intervention type, and phase of study. Conclusions: From 2000 through 2022, the number of spine-related clinical trials initiated annually markedly increased, driven by an increase in institutionally sponsored trials. Specific trial characteristics were more or less likely for industrially or federally sponsored trials relative to institutionally sponsored trials suggesting the types of clinical trials are shifting over time.

Keywords

• Spine
• Clinical trials
• Interventional studies
• Sponsorship
• Study sponsorship
• Blinding