QLTI-12. ADULT NEURO-ONCOLOGY TRIAL LANDSCAPE IN THE UNITED STATES OVER FIVE DECADES

Abstract

Abstract PURPOSE The unmet therapeutic needs in neuro-oncology remain significant due to the biological and clinical challenges. Clinical trials are important to close the gap between therapeutic unmet needs and scientific advances. This study aims at analyzing the landscape of neuro-oncology trials to identify completion and failures and guide strategies for the path forward. METHODS US-registered adult neuro-oncology clinical trials were extracted from www.clinicaltrials.gov (1966-2019) to include funding source, trial type, scope, phase, and subjects’ demographics. Trial failures comprised “terminated,” “withdrawn,” and/or “suspended” trials. Univariate and multivariate analysis were used to detect differences across factors and over time. RESULTS Our search yielded 4522 trials, 1257 eligible for this study. In 25 US States, neuro-oncology trials availability is < 0.85/100,000 population. Over time, completed trials have decreased with a significant increased percentage of trial failures from 22% to 36% (p < 0.001). Overtime, NIH funding decreased from 47% to 24% (p < 0.001). Inclusion of subjects ≥ 65-year-old and women increased in the last decade (p < 0.001) while inclusion of Hispanic subjects has decreased (p < 0.001). The top two reasons for failure included accrual and operational difficulties. Industry-funded trials had a trend toward higher failure rate than NIH-funded. A larger proportion of women (p < 0.001), non-Hispanic subjects (p = 0.001), and older adult (p < 0.001) patients were enrolled in completed trials than in failed trials. CONCLUSION Our study is the first report on the neuro-oncology clinical trial landscape in the US over time. The data support the concept that strategies to further the availability of clinical neuro-oncology trials within the US are necessary. As these are developed, attention is needed to identifying and modifying factors contributing to clinical trial failures.