RESUMO
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.
RESUMO
Background: African contribution to global research output is said to be low. Poor funding and poor skills in grant writing have been suggested as important factors for this situation. Objectives: Applications for research ethics clearance in a hospital were reviewed to have an overview of the planned studies and the proportion of them that attracted national and international funding. Methods: A review of all applications for ethical clearance received by the institutional review board of a university teaching hospital at Ile-Ife, Nigeria, from 2016 to 2020. They were analysed according to study nature, scope, purpose, and sponsorship using descriptive statistics presented as frequency tables and charts. Results: A total of 878 applications were reviewed. There were 803 (91.5%) applications for local, 45 (5.1%) for national multicentre, and 30 (3.4%) for international multicentre studies. Applications for medical fellowship were 352 (40.0%) while 208 (23.8%) were from academic staff for non-degree research. There were 610 (69.5%) applications for self-sponsored studies. Only 18 (2.0%) and 26 (3.0%) received sponsorship from national and international donor agencies, respectively. Conclusions: Local studies formed the bulk of the submissions for ethics clearance. National and international donor funding of research is abysmally low in this Nigerian tertiary institution studied.