A population study of clinical trial accrual for women and minorities in neuro-oncology following the NIH Revitalization Act

Abstract

BACKGROUND The 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. METHODS Registry 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. RESULTS Among 662 published clinical trials representing 49,907 participants, 62.5% of participants were men and 37.5% 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. CONCLUSIONS Following the Revitalization Act, minorities and women remain underrepresented in therapeutic clinical trials for neuroepithelial tumors, relative to disease incidence and mortality. Study accrual has improved with time. This study provides a framework for clinical trial accrual efforts and offers guidance regarding workforce considerations associated with enrollment of underserved patients.

Neurosurgical Outcomes for Pediatric Central Nervous System Tumors in the United States

“…Similar findings have been reported for adult patients with GBM. 11-13 We demonstrate that treatments and outcomes differ by patient race, income, and insurance status. In addition, patients of lower socioeconomic status were more often treated at LVF, and these were both risk factors for poorer outcomes.…”

Indigenous peoples and inclusion in clinical and genomic research: Understanding the history and navigating contemporary engagement

“…Through their respective roles as clinical trial and large-scale data sharing networks, each organization recognizes the essential nature of diverse patient and community participation in clinical research, data collection and open sharing. Unfortunately, historic and contemporary data demonstrate that underrepresented groups are more likely to die from cancer and less likely to enroll in clinical research [1] , [2] , [3] , [4] , [5] . In addition, there is a dearth of underrepresented populations from the professional fields involved in clinical research leading to a gap in representation throughout medical and research systems [6] , [7] , [8] , [9] .…”

“…However, cancer remains the top cause of death by disease in children [11] due to several factors, including but not limited to, cancer subtypes with incredibly low survival and treatment disparities such as barriers in access to clinical trials. Race and ethnicity have been specifically associated with disparities in survival of CNS tumors [1] , [3] , [4] , [5] . Non-white children from lower socioeconomic particularly demonstrate lower overall survival compared to white children [12] .…”

“…One of the most thorough ways to ensure that the needs of Indigenous communities are met and that research is effectively communicated is to integrate Indigenous people into the research process, allow them a seat at the table, and provide them resources to build their own tables [3] . This engenders trust and ensures tribes feel supported by a research team that has their best interests in mind.…”

Sexual dimorphism of the immune system predicts clinical outcomes in glioblastoma immunotherapy: A systematic review and meta-analysis

“…Because of this, current available literature in almost all disease processes is highly skewed and biased toward males. 4 , 6 , 7 …”