Introduction: Despite advancements in cancer treatment, central nervous system (CNS) tumors, including glioblastoma (GBM) and metastatic brain disease, remain highly lethal. Neurosurgeons, traditionally focused on surgical care, are emerging as key leaders in clinical trials, particularly in advancing novel therapeutic strategies. However, their representation as principal investigators (PIs) in neuro-oncology clinical trials remains limited. This study aims to analyze trends in neurosurgeon-led trials, assess barriers to their leadership, and propose strategies to enhance their involvement.
Methods: We conducted a systematic search of ClinicalTrials.gov for neuro-oncology trials in the United States as of October 2024. Trials were analyzed for recruitment status, PI specialty, intervention type, and funding sources. Geographic distribution of neurosurgeon-led trials was assessed alongside NIH funding data and neurosurgical residency programs. Statistical analyses, including regression analysis, were performed to evaluate correlations between NIH funding and neurosurgeon-led trials.
Results: Among 532 U.S.-based neuro-oncology trials, oncologists led 34.7%, while neurosurgeons only led 22.4%. Neurosurgeons were most involved in early-phase trials, with 36.7% classified as phase 1 and only 5.1% as phase 3/4. A strong correlation was observed between neurosurgeon-led trials and NIH funding for their respective neurosurgery department (R²=0.6146, p< 0.001). However, 84.2% of neurosurgeon PIs received no direct NIH funding. Gender disparities were also noted, with only 13.2% of neurosurgeon PIs being female.
Conclusion : Neurosurgeons play a crucial role in neuro-oncology clinical research. However, their limited representation as PIs, particularly in later-phase studies, suggests barriers in funding, mentorship, and institutional support. Strengthening financial and educational resources for neurosurgeon-led trials may enhance their leadership in neuro-oncology, ultimately improving patient outcomes.
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