Disparities In Trial Participation Research Articles

Using an AI trial screening tool to assess language as a barrier for enrollment of underrepresented minorities in cancer clinical trials.

e13586 Background: A major limitation of clinical trials is limited generalizability due to low enrollment of underrepresented minorities (URM). The percentage of patients who are non-English speaking (NES) is higher in URM and language barriers may discourage providers to offer participation in clinical trials. We have developed an artificial intelligence-based system to identify patients eligible for clinical trials, Clinical Trials Patient Matching (CTPM). This platform offers an ideal opportunity to explore bias in enrolling patients on clinical trials (CT). Among patients identified by CTPM as eligible for CT we assessed the impact of NES on trial enrollment. Methods: Individual algorithms were constructed within CTPM to identify patients potentially eligible for two trials open at Yale Cancer Center, DARE (NCT04567420) and EMBER-4 (NCT05514054). Eligibility was confirmed by Clinical Trials Office staff and notification of eligibility was communicated to the treating provider. Retrospectively, we evaluated the impact of NES status on clinical trial enrollment. This analysis occurred between 9/1/2022 and 11/30/2023 and all study-related activities were approved by the Yale IRB. Results: Out of the 13,466 unique patients presenting to the Yale Cancer Center and Smilow Cancer Network breast program within the period of study, 5.1% were NES and 94.9% were English speaking (ES). Of the patients identified by CTPM as eligible for the 2 clinical trials 7.9% were NES and 92.14% were ES. However, out of patients enrolled, only 1.59% were NES and 98.41% were ES. For the DARE trial, enrollment rate was 38.3% for ES vs 0% for NES (p=0.0081). For the EMBER4 trial, enrollment was 13.4% for ES vs 14.3% for NES (p=1.0). The aggregate data for both trials revealed an enrollment rate of 29.4% for ES vs 5.6% for NES (p=0.0285). Conclusions: We found that patients who identify as NES were less likely to be enrolled in cancer clinical trials. CTPM appears to be an effective tool to prospectively identify underrepresented populations in clinical trials and serve as a platform for developing interventions to address disparities in trial participation, including language. [Table: see text]

An evaluation of biobanking and therapeutic clinical trial representation among adult glioma patients from rural and urban Utah.

Social determinants of health (SDOHs)-specifically those related to rurality, health care accessibility, and income-may play as-yet-unidentified roles in prognosis for glioma patients, and their impact on access to clinical trials is important to understand. We examined SDOHs of patients enrolled in glioma clinical trials and evaluate disparities in trial participation and outcomes between rural and urban patients. We retrospectively identified patients enrolled in glioma clinical trials at Huntsman Cancer Institute (HCI) from May 2012 to May 2022 to evaluate clinical trial participation. We used multivariable models to evaluate SDOHs and geographic information system mapping to assess representation across Utah's counties. We utilized the most recent 10-year datasets of patients treated for glioma at HCI and from the Utah Cancer Registry to analyze survival and incidence, respectively. A total of 570 participants (68 trials) resided in Utah, 84.4% from urban counties, 13.5% from rural counties, and 2.1% from frontier (least-populous) counties. Nineteen counties (65.5%) were underrepresented in trials (enrolled participants vs. eligible), 1 (3.5%) was represented in a near-1:1 ratio, and 9 (31.0%) were overrepresented. Counties with greater enrollment had greater population densities, highest per-capita income, and proximity to HCI. Among patients treated at HCI, patients from rural/frontier counties had equivalent survival with urban patients across nearly all glioma types, including glioblastomas, despite underrepresentation in clinical trials. By highlighting disparities in clinical trial enrollment, our results can support efforts to improve recruitment in underrepresented regions, which can assist providers in delivering equitable care for all patients.

Clinical Trial Participation Among Older Adult Medicare Fee-for-Service Beneficiaries With Cancer

Clinical trials play a critical role in the development of novel cancer therapies, and precise estimates of the frequency with which older adult patients with cancer participate in clinical trials are lacking. To estimate the proportion of older adult Medicare Fee-for-Service (FFS) beneficiaries with cancer who participate in interventional cancer clinical trials, using a novel population-based methodology. In this retrospective cohort study evaluating clinical trial participation among older adult patients with cancer from January 1, 2014, through June 30, 2020, claims data from Medicare FFS were linked with the ClinicalTrials.gov to determine trial participation through the unique National Clinical Trial (NCT) identifier. The proportion of patients with newly diagnosed or newly recurrent cancer in 2015 participating in an interventional clinical trial and receiving active cancer treatment from January 2014 to June 2020 was estimated. Data analysis was performed from November 18, 2020, to November 1, 2021. Patients with cancer aged 65 years or older with Medicare FFS insurance, with and without active cancer treatment. Enrollment in clinical trials among all patients with cancer 65 years and older and among patients receiving active cancer treatments as defined by the presence of at least 1 NCT identifier corresponding to an interventional cancer clinical trial in Medicare claims. Among 1 150 978 patients (mean [SD] age, 75.7 [8.4] years; 49.9% men and 50.1% women) with newly diagnosed or newly recurrent cancer in 2015, 12 028 (1.0%) patients had a billing claim with an NCT identifier indicating enrollment in an interventional cancer clinical trial between January 2014 and June 2020. In a subset of 429 343 patients with active cancer treatment, 8360 (1.9%) were enrolled in 1 or more interventional trials. Patients enrolled in a trial tended to be younger, male, a race other than Black, and residing in zip codes with high median incomes. Findings of this cohort study show that clinical trial enrollment among older adult patients with cancer remains low, with only 1.0% to 1.9% of patients with newly diagnosed or recurrent cancer in 2015 participating in an interventional cancer clinical trial as measured by the presence of NCT identifiers in Medicare claims. These data provide a contemporary estimate of trial enrollment, persistent disparities in trial participation, and only limited progress in trial access over the past 2 decades.

Impact of Workforce Challenges and Funds Flow on Cancer Clinical Trial Development and Conduct.

The conduct of clinical cancer research has faced considerable challenges in recent years, and the situation has only been exacerbated by the global pandemic. The growing complexity of clinical trials and rising administrative burdens had been causing greater expense and difficulty in recruiting and retaining an appropriately trained workforce even before the well-publicized increase in turnover caused by the pandemic. Longstanding issues such as restrictive inclusion criteria and complicated trial designs have negatively affected already low clinical trial accrual rates, limited sites capable of opening studies and enrolling patients, and worsened disparities in trial participation. Opposing these elements are efforts by ASCO and other organizations to increase affordability, access, and equity in clinical trial enrollment. To provide diverse perspectives on how these challenges are affecting cancer research as we emerge from the pandemic, we asked a panel of experienced clinical research leaders from both academic and community cancer centers to answer questions they felt most pressing about the business of conducting clinical research today and where they felt the field was moving in the near future.

Use of modernized eligibility criteria in pancreatic cancer clinical trials.

6545 Background: In 2017, ASCO + Friends recommended modernized eligibility criteria to improve generalizability of clinical trial results. Traditional criteria contribute to disparities in trial participation, yet modernized criteria can equalize eligibility rates. We aimed to assess use of modernized eligibility criteria in pancreatic ductal adenocarcinoma (PDAC) clinical trials since the updated guidelines. Methods: Modernized eligibility criteria were obtained from ASCO + Friends guidelines. Clinicaltrials.gov was queried for “pancreas adenocarcinoma” trials from Jan. 1, 2018 onward and eligibility criteria were assessed for compliance with modernized criteria. Kruskal-Wallis and Fisher’s exact tests were used to determine differences in compliance based on disease stage(s), starting year, phase, and funder. Results: In total, 108 clinical trials were identified - 31.5% for resectable, 56.5% for unresectable, 12.0% for both resectable/unresectable disease. Most trials were phase 1 (24.1%), phase 1|2 (15.7%) or phase 2 (45.4%). Funding sources included industry (38.0%), NIH (22.2%) and other sources (39.8%). No trial was compliant with all modernized criteria. Only 34.7% of trials allowed patients with ECOG performance status of 2. HIV+ patients were not allowed in 56.5% of trials. Only 7 trials (6.5%) were compliant with assessing renal function whereas 64.8% appropriately used upper limit of normal cutoffs for labs. Among trials that excluded patients for CHF, 59.6% used a classification system for exclusion. Specific cardiac abnormalities were excluded in 60.2% of trials. Prior malignancy was allowed in 71.3% of trials if treated > 2 years prior and concurrent malignancy, if stable, was allowed in 21.3% of trials. Prior PDAC treatment was allowed for 38.0% and required for 24.1% of trials. If prior treatment was allowed, 94% justified drug exclusions, 40.3% did not require a washout period, and 35.8% required recovery from prior adverse events. Stable/treated brain metastases were allowed in 33.8% of trials for unresectable cancer. Compliance with prior malignancy criteria improved from 2018-2019 to 2020-2022 (56.0% vs 84.5%, respectively; p = 0.001). Requirement of prior PDAC treatment was associated with disease stage (8.8% for resectable, 32.8% for unresectable, and 23.1% for both; p = 0.024), as was exclusion based on prior therapy (58.8% for resectable disease, 14.8% for unresectable, and 30.8% for both; p < 0.0001). Earlier trial phase was associated with prior treatment allowance (p = 0.002), whereas later phase trials were less likely to allow prior treatment (p = 0.021). NIH-funded trials required prior treatment (37.5%) more than industry (29.3%) or other (11.6%) funded trials (p = 0.034). Conclusions: Modernized eligibility criteria are inadequately implemented in PDAC clinical trials. Efforts to improve their use are warranted to produce more generalizable results and advance inclusivity.

Impact of locus of care on outcomes in adolescents and young adults with osteosarcoma and Ewing sarcoma treated at pediatric versus adult cancer centers: An IMPACT cohort study.

Location of cancer care (LOC; pediatric vs. adult center) impacts outcomes in adolescents and young adults (AYA) with some cancer types. Data on the impact of LOC on survival in AYA with osteosarcoma (OSS) and Ewing sarcoma (EWS) are limited OBJECTIVES: To compare differences in demographics, disease/treatment characteristics, and survival in a population-based cohort of AYA with OSS or EWS treated at pediatric versus adult centers METHODS: The Initiative to Maximize Progress in Adolescent Cancer Therapy (IMPACT) cohort captured demographic, disease, and treatment data for all AYA (15-21years old) diagnosed with OSS and EWS in Ontario, Canada between 1992 and 2012. Patients were linked to provincial administrative health care databases. Outcomes were compared between patients treated in pediatric versus adult centers. One hundred thirty-seven AYA were diagnosed with OSS (LOC: 47 pediatric, 90 adult) and 84 with EWS (38 pediatric, 46 adult). AYA treated at pediatric centers were more likely to be enrolled in a clinical trial (OSS 55% vs. 1%, p<.001; EWS 53% vs. 2%, p<.001) and received higher cumulative chemotherapy doses. Five-year event-free survival (EFS ± standard error) in OSS and EWS were 47% ± 4% and 43% ± 5%, respectively. In multivariable analysis, the impact of LOC (pediatric vs. adult center) on EFS in OSS (adjusted hazard ratio [HR] 1.15, 95% confidence interval [CI]: 0.58-2.27, p=.69) and EWS (adjusted HR 1.82, 95% CI: 0.97-3.43, p=.06) was not statistically significant. Despite disparities in trial participation and chemotherapy doses, outcomes did not differ by LOC suggesting that AYA with bone tumors can be treated at either pediatric or adult centers.

Abstract 2624: Clinical trial participation in real-world patients with metastatic breast cancer: disparities and barriers

Abstract Background: Reducing barriers to patient participation in clinical trials is vitally important to the cancer care community. Using data from a real-world cohort of metastatic breast cancer (mBC) patients (pts), we evaluated how race/ethnicity and other socioeconomic, institutional, and clinical barriers play a role in trial participation. Methods: Adult females with mBC were selected from Flatiron Health EHR-derived de-identified database (2011- 2020). Clinical trial participation was determined by having “clinical study drug” in any line of therapy. Multivariate logistic regressions were used to assess how various barriers impact trial participation. Results: In this cohort of 22,220 mBC pts, 1,131 (5.1%) were enrolled in clinical trials and participation rates vary by line of therapy, race/ethnicity, age, insurance, location, and care setting (Table 1). Comparing pts characteristics between enrolled vs. not enrolled, pts ever enrolled were significantly younger (mean age: 59 vs 63), had better performance status (ECOG PS ≥ 2: 3% vs 8%), and less Brain/CNS metastasis (3% vs 6%), more likely to be white (75% vs 61%), lived in the south (55% vs 38%), and had commercial insurance (34% vs 29%), with all p&amp;lt;0.001. Controlling for all SES and clinical characteristics that significantly differ between pts enrolled vs. not enrolled, racial/ethnic minority status remained as a strong predictor for lack of trial participation ([OR(95%CI)]: African-American(AA) [0.5(0.4-0.7)]; Hispanic: [0.6(0.4-0.8)], vs White). Conclusions: Preliminary results of this study reveal significant demographic and socioeconomic disparities in trial participation among mBC patients. In particular, AA and Hispanic patients were less likely to participate in clinical trials after controlling for other individual- or system-level factors that may impact enrollment. Future efforts to understand the relationship between racial disparity and other well-known barriers are needed. TABLE 1.Proportion of Patients Enrolled in Clinical Trials (N=22,220)Total, NProportion enrolled in clinical trials, n(%)Line of Therapy1L19,559435 (2.2%)2L12,627336 (2.7%)3L+7,959360 (4.5%)*Age at Diagnosis&amp;lt;6511,356732 (6.4%)*65 - 755,801273 (4.7%)75+5,063126 (2.5%)Race/EthnicityAfrican-American2,39597 (4.1%)Hispanic or Latino1,70251 (3.0%)Asian49420 (4.1%)White13,707851 (6.2%)*Other/Unknown3,922112 (2.9%)Geographic RegionMidwest3,062106 (3.5%)Northeast3,89476 (2.0%)South8,645618 (7.2%)*West3,998174 (4.4%)Insurance at DiagnosisCommercial6,398388 (6.1%)*Medicaid49013 (2.7%)Medicare4,232158 (3.7%)Other or Missing11,100572 (5.2%)Care SettingAcademic1,558137 (8.8%)*Community20,662994 (4.8%)Note: * denotes subgroup of patients with the highest rate of clinical trial participation Citation Format: Ruoding Tan, Rongrong Wang, Ibrahim Abbass, Lourenia Cassoli, Edith P. Mitchell. Clinical trial participation in real-world patients with metastatic breast cancer: disparities and barriers [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2021; 2021 Apr 10-15 and May 17-21. Philadelphia (PA): AACR; Cancer Res 2021;81(13_Suppl):Abstract nr 2624.

Non-English language validation of patient-reported outcome measures in cancer clinical trials.

Patient-reported outcome measures (PROMs) are increasingly incorporated as endpoints in oncology clinical trials but are often only validated in English. ClinicalTrials.gov was queried for cancer-specific randomized control trials (RCTs) addressing a therapeutic intervention and enrolling primarily in the USA. Peer-reviewed validation of Spanish and Chinese versions of each PROM was assessed. Of 103 eligible trials, a PROM was used as a primary endpoint in 25 RCTs (24.3%) and as a secondary endpoint in 78 RCTs (75.7%). A total of 61 of the 103 eligible trials (59.2%) and 17 of the 25 trials with a PROM primary endpoint (68.0%) used a PROM with either no Spanish or Chinese validation. The absence of validated PROM translations may diminish the voices of non-English language speaking trial participants. With an increasingly diverse US population, validation of non-English PROM translations may decrease disparities in trial participation and improve generalizability of study results.

A Case-Control Study Examining Disparities in Clinical Trial Participation Among Breast Surgical Oncology Patients.

BackgroundClinical trial participation among racial and ethnic minorities remains low despite national efforts. We sought to determine how participation in clinical trials by breast surgical oncology patients has changed over time and what characteristics are associated with participation. MethodsWomen with breast cancer enrolled in National Cancer Institute–sponsored, cooperative-group trials from 2000 to 2012 and who underwent oncologic surgery (n = 17 125) were compared with trial-eligible women in the National Cancer Database diagnosed in 2000–2012 (n = 792 719). Race-specific trial participation was plotted over time by income and reported as a proportion of the combined cohorts. Factors associated with trial participation were estimated using logistic regression; we report odds ratios (ORs) with 95% confidence intervals (CIs). A P value less than .05 was considered statistically significant for all analyses. All tests were two-sided.ResultsParticipation declined across all groups over time because of a decrease in the scale and number of trials. In 2000–2003, Asian–Pacific Islander (7.17%), Hispanic (3.48%), and white (7.13%) patients from the highest income group had higher participation than their lower-income counterparts (Asian–Pacific Islander: 3.95%; Hispanic: 2.67%; white: 5.96%), but by 2008–2012, only high-income white patients participated more than lower-income whites (0.32% vs 0.25%, all P < .01). Black (OR = 0.80, 95% CI = 0.75 to 0.85) and Hispanic (OR = 0.84, 95% CI = 0.77 to 0.92) patients were less likely to participate than whites, but there were statistically significant interactions between income and race and ethnicity, with high-income black patients being approximately 50% less likely to participate than lower-income blacks (all P < .001). ConclusionsMultifaceted interventions addressing the intersectionality of race, ethnicity, and other patient characteristics are needed to address persistent disparities in trial participation among breast surgical oncology patients.

Enrollment disparities in cancer clinical trials: A single institution experience.

e18128 Background: The importance of population heterogeneity in clinical cancer research is universally recognized. This study aims to identify possible disparities in trial participation at UF Health Cancer Center at Orlando Health. Methods: Data on patients’ enrollment, during the period from 01/01/2016 to 12/31/2016, was obtained from our research C-base. We utilized descriptive statistics to characterize the main demographic variables. Pearson's Chi-squared and Z-tests were utilized to compare percentages of enrolled versus not enrolled patients by ethnicity, race and gender. Results: A total of 3704 cases were established as new patients during the study period, of which 369 (10%) were enrolled in cancer research studies (Table). Our analysis showed statistically significant differences in enrollment by racial category (χ2= 95.09, df = 3, p &lt; 0.0000). American Indian (n = 6) and Native Hawaiian (n = 4), were excluded from the analysis due to small sample sizes and no enrollments. In addition we tested with the Z-stat whether the enrollment in each group was different from the population average (p = 0.10). The Caucasian group did not differ from the average (z = 0.3944; p &lt; 0.6933), whereas both the African American (z = -4.2286; p &lt; 0.0001) and the Asian group (z = -2.3102; p &lt; 0.0209) were under enrolled. The Others group was above the average (z = 8.4632; p &lt; 0.0001). There were also differences in enrollment by gender and ethnicity. Females were under enrolled as compared to Males (z = -7.0716; p &lt; 0.0001). The Hispanic group enrollment was significantly below the population average (z = -4.17; p &lt; 0.0001). Conclusions: We found significant differences in the enrollment of minorities in cancer trials in our institution. African Americans, Asians, Hispanics and Females were all under represented. The group labeled as Others requires further attention. [Table: see text]