A Population Study of Clinical Trial Accrual for Women and Minorities in Neuro-Oncology Following the NIH Revitalization Act
Authors: Reihl Sheantel J. , Patil Nirav , Morshed Ramin A. , Mehari Mulki , Aabedi Alexander , Chukwueke Ugonma N. , Porter Alyx B. , Fontil Valy , Cioffi Gino , Waite Kristin , Kruchko Carol , Ostrom Quinn , Barnholtz-Sloan Jill , Hervey-Jumper Shawn L. 
Published: June 2021

AbstractBACKGROUNDThe NIH Revitalization Act, implemented 29 years ago, set to improve the representation of women and minorities in clinical trials. In this study, we investigate progress made in all phase therapeutic clinical trials for neuro-epithelial CNS tumors stratified by demographic-specific age-adjusted disease incidence and mortality. Additionally, we identify workforce characteristics associated with clinical trials meeting established accrual benchmarks.METHODSRegistry study of published clinical trials for World Health Organization defined neuro-epithelial CNS tumors between January 2000 and December 2019. Study participants were obtained from PubMed and ClinicalTrials.gov. Population-based data originated from the CBTRUS for incidence analyses. SEER-18 Incidence-Based Mortality data was used for mortality analysis. Descriptive statistics, Fisher exact, and χ2 tests were used for data analysis.RESULTSAmong 662 published clinical trials representing 49,907 participants, 62.5% of study participants were men and 37.5% were women (P<0.0001) representing a mortality specific over-accrual for men (P=0.001). Whites, Asians, Blacks, and Hispanics represented 91.7%, 1.5%, 2.6%, and 1.7% of trial participants. Compared with mortality, Blacks (47% of expected mortality, P=0.008), Hispanics (17% of expected mortality, P<0.001) and Asians (33% of expected mortality, P<.001) were underrepresented compared with Whites (114% of expected mortality, P<0.001). Clinical trials meeting accrual benchmarks for race included minority authorship.CONCLUSIONSFollowing the Revitalization Act, minorities and women remain underrepresented when compared with their demographic-specific incidence and mortality in therapeutic clinical trials for neuroepithelial tumors. This study provides a framework for clinical trial accrual efforts and offers guidance regarding workforce considerations associated with enrollment of vulnerable patients.Key PointsMinorities and women with brain tumor diagnosis remain significantly under-accrued for neuro-oncology clinical trials compared to Caucasians and men based on proportional disease burden and demographic-specific mortality.Importance of the StudyThe current state of clinical trial accrual in the U.S. for adult patients with gliomas across different demographic groups has not been comprehensively studied. This study aims to quantify clinical trial accrual by age-adjusted disease incidence and mortality for gender and race during a 20-year period following the NIH Revitalization Act, and to identify workforce characteristics associated with clinical trials meeting established race and gender accrual benchmarks. Minorities and women with brain tumor diagnosis remain significantly under-accrued for neuro-oncology clinical trials compared to Caucasians and men based on proportional disease burden and demographic-specific mortality. Despite the enactment of the NIH Revitalization Act to improve the representation of women and minorities in clinical trials nearly 30 years ago, this goal remains unmet in the field of neuro-oncology. Significant work is required to continue to implement and improve interventions to increase accrual of diverse patient populations.