Evaluating the Landscape of Clinical Research in Neurosurgery

Abstract

BACKGROUND: Many clinical trials and observational research never reach publication in peer-reviewed journals. Unpublished research results, including neutral study findings, hinder generation of new research questions, utilize healthcare resources without benefit, and may place patients at risk without benefit. OBJECTIVE: To examine the publication of neurosurgery trials listed in ClinicalTrials.gov. METHODS: Clinical neurosurgery research was identified by searching the registry and categorized by study type. Associated publications were identified on Pubmed.gov. RESULTS: Among the 709 studies identified, spine (292, 41.2%) studies were most common, followed by tumor and cranial (each 114, 16.1%). Funding was predominantly private (482, 68.0%), followed by industry (135, 19.0%) and National Institutes of Health (9, 1.3%). A lower proportion of published studies (vs unpublished) received private funding in functional (33.3 vs 65.3%) and tumor (80.0 vs 68.7%). Only 104/464 (22.4%) studies had an associated publication. The mean time from listed study completion to first publication was 31.0 ± 27.5 mo. Most published studies had significant study differences between treatment arms (n = 72, 69.2%); studies with neutral findings were less likely to be published (n = 13, 12.5%). Surgical discipline (P = .1), funding source (P = .8), patient age (P = .4), planned enrollment (P = .1), phase of trial (P = .3), and study type (P = .2) did not affect publication rates. However, the interaction between study category and funding source significantly affected publication rate (P = .04, generalized linear model, R2 = 0.05). Publication timing (1-way analysis of variance, P = .5) and frequency (chi-square, P = .2) did not differ among disciplines. CONCLUSION: Clinical trials and observational research in neurosurgery are often not published promptly, especially if results were nonsignificant or the trial had private funding.

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