Trial Enrollment Research Articles

Impact of an Oncology Clinical Pharmacist Intervention on Clinical Trial Enrollment in The US Oncology Network’s MYLUNG Consortium

Introduction: The Molecularly Informed Lung Cancer Treatment in a Community Cancer Network: A Pragmatic Consortium™ (MYLUNG) clinical trial platform aims to advance the use of precision medicine in patients with non–small cell lung cancer through a series of prospective and iterative clinical trials. Timely patient accrual onto oncology clinical trials is a known practice challenge and impaired accrual rates can lead to premature trial closure or properly powered trial outcomes. The US Oncology Network recently implemented a clinical pharmacist (ClinReview) initiative to provide remote clinical services to screen patients for enrollment onto MYLUNG Protocol 2. This study aims to evaluate the effect of the remote clinical pharmacist intervention on study enrollment rates. Methods: An oncology-trained clinical pharmacist remotely reviewed systemic chemotherapy treatment orders during normal workflow and, in addition, a weekly custom recruitment report within six community Network practices (149 physicians). The pharmacist identified, screened, and assisted with the communication regarding eligible patients for enrollment. The onsite research team received timely and relevant patient data to facilitate expedited enrollment. Enrollment and intervention data were tracked to monitor the impact of the pharmacist intervention. Monthly enrollment was evaluated using a paired t-test. Results: Over 8 months, the pharmacist screened 506 potentially eligible patients; 34% were enrolled. Average monthly enrollment was significantly greater following the ClinReview intervention (3.4 vs. 6.6 patients/month; p = .02). Among the 289 patients not enrolled, 73% exceeded their eligibility window, 9% died or enrolled into hospice, 4% declined participation, and 13% transferred care or were treated at outside facilities. Conclusions: Incorporating an oncology clinical pharmacist into the clinical research team was associated with improved clinical trial enrollment. Validation of the effect of multidisciplinary interventions across a broader spectrum of differentially resourced oncology practices will be conducted within future MYLUNG iterations.

Protect peripheral intravenous catheters: a study protocol for a randomised controlled trial of a novel antimicrobial dressing for peripheral intravenous catheters (ProP trial)

IntroductionPeripheral intravenous catheters (PIVCs) are the most commonly used vascular access device in hospitalised patients. Yet PIVCs may be complicated by local or systemic infections leading to increased healthcare costs....

Investigating racial and gender disparities in virtual randomized clinical trial enrollment: Insights from the BE ACTIVE study

Randomized clinical trials (RCTs) often suffer from a lack of representation from historically marginalized populations, and it is uncertain whether virtual RCTs (vRCTs) enhance representativeness or if elements of their consent and enrollment processes may instead contribute to underrepresentation of these groups. In this study, we aimed to identify disparities in enrollment demographics in a vRCT, the BE ACTIVE study, which recruited patients within a single health system. We discovered that the proportions of eligible patients who were randomized differed significantly by gender and race/ethnicity (men 1.2%, women 2.0%, P < .001; White 1.8%, Black 1.3%, Hispanic 0.7%, Asian 0.9%; P < .001), and compared with White patients, non-White patients were less likely to have a valid email address on file and were less likely to click on the email link to the study webpage and begin enrollment.

Poverty, race, ethnicity, and survival in pediatric nonmetastatic osteosarcoma: a Children's Oncology Group report.

Children living in poverty and those of marginalized race or ethnicity experience inferior disease outcomes across many cancers. Whether survival disparities exist in osteosarcoma is poorly defined. We investigated the association between race, ethnicity, and proxied poverty exposures and event-free and overall survival for children with nonmetastatic osteosarcoma receiving care on a cooperative group trial. We conducted a retrospective cohort study of US patients with nonmetastatic, osteosarcoma aged 5-21 years enrolled on the Children's Oncology Group trial AOST0331. Race and ethnicity were categorized to reflect historically marginalized populations, as Hispanic, non-Hispanic Black, non-Hispanic Other, and non-Hispanic White. Poverty was proxied at the household and neighborhood levels. Overall survival and event-free survival functions of time from trial enrollment were estimated using the Kaplan-Meier method. Hypotheses of associations between risks for event-free survival, death, and postrelapse death with race and ethnicity were assessed using log-rank tests. Among 758 patients, 25.6% were household-poverty and 28.5% neighborhood-poverty exposed. Of the patients, 21% of children identified as Hispanic, 15.4% non-Hispanic Black, 5.3% non-Hispanic Other, and 54.0% non-Hispanic White. Neither household or neighborhood poverty nor race and ethnicity were statistically significantly associated with risks for event-free survival or death. Postrelapse risk for death differed statistically significantly across race and ethnicity with non-Hispanic Black patients at greatest risk (4-year postrelapse survival 35.7% Hispanic vs 13.0% non-Hispanic Black vs 43.8% non-Hispanic Other vs 38.9% non-Hispanic White; P = .0046). Neither proxied poverty exposures or race and ethnicity were associated with event-free survival or overall survival, suggesting equitable outcomes following frontline osteosarcoma trial-delivered therapy. Non-Hispanic Black children experienced statistically significant inferior postrelapse survival. Investigation of mechanisms underlying postrelapse disparities are paramount.

Factors associated with acceleration of clinical development for infectious diseases: a cross-sectional analysis of 10-year EMA registration data

Clinical trials feature centrally in the development of drugs and vaccines to determine safety and efficacy. Clinical development can be slow and may have a duration of more than ten years. Global public health threats such as Ebola virus disease (EVD) and COVID-19 have demonstrated that it is possible to accelerate clinical trials while maintaining safety and efficacy. We investigated acceleration in clinical trials over the past decade and identified factors associated with acceleration for drugs targeting infectious diseases. A cross-sectional study was performed of all medicinal compounds targeting infectious diseases that received marketing authorisation by the European Medicines Agency (EMA) between 2012 and 2022. We calculated median clinical development time in years between the first phase 1 trial enrolment date and the authorisation date. Multivariable linear regression analysis was performed to identify factors associated with shorter development times. Eighty-one trajectories were included. The median clinical development time was 7.3 years (IQR 4.4-12.3). The fastest times belonged to drugs and vaccines targeting COVID-19 (1.3 years, IQR 0.8-1.6), EVD (5.5 years, IQR 5.1-5.8), and Hepatitis A-E (5.5 years, IQR 3.9-8.2). Factors associated with shorter development times were outbreak setting (-5.4 years [95% CI,-8.2 to-2.6]), accelerated assessment status (-4.0 years [95% CI,-7.6 to-0.5]), and drugs with combined compounds (-2.7 years [95% CI,-4.9 to-0.4]). Clinical development time for infectious disease-related drugs and vaccines was relatively short, and outbreak setting and accelerated EMA assessment were associated with shorter development times. Amsterdam Public Health research institute.

Real-world outcomes for patients with pleural mesothelioma: A multisite retrospective cohort study.

To evaluate the real-world treatment patterns and outcomes for patients with pleural mesothelioma (PM) in the era of immunotherapy. This retrospective audit included patients with PM diagnosed within three tertiary referral centers in Queensland, Australia from January 2017 to July 2023. Patient and treatment characteristics and outcomes were recorded. Data was analyzed using descriptive statistics and the Kaplan-Meier survival method. A total of 90 patients were included: 84% were male, the median age was 75 years (range 70-79) and 85% had baseline Eastern Group Cooperative Group of 0-1. Subtypes included 54% epithelioid, 17% biphasic, 12% sarcomatoid, and 17% unspecified/unknown. First-line treatment was received by 57/90 patients (63%) and 33/90 patients (37%) received the best supportive care (BSC). Chemotherapy was most used (63%) overall, but first-line immunotherapy was more commonly used since ipilimumab/nivolumab was reimbursed by the Australian Pharmaceutical Benefits Scheme in July 2021. After first-line treatment, only 40% received second-line treatment and 60% received BSC. 12-month overall survival (OS) and progression-free survival for all patients were 53% (95% confidence interval [CI]: 43-65) and 25% (95% CI 15-40) respectively. 12-month OS was 72%, 64%, and 29% for immunotherapy, chemotherapy, and BSC, respectively. There was no significant difference in survival between chemotherapy and immunotherapy (hazard ratio 1.28, 95% CI: 0.65-2.5, p=0.5). In our unselected real-world cohort, both chemotherapy and immunotherapy are active against PM, but the prognosis remains guarded. There remains a need for better treatment options, especially in the first-line setting. Enrolment in clinical trials is crucial to improving outcomes in this debilitating disease.

OTHR-18. IMPACT OF COVID-19 ON CLINICAL TRIAL ENROLLMENT IN THE DEPARTMENT OF PEDIATRIC HEMATOLOGY ONCOLOGY AT WASHINGTON UNIVERSITY SCHOOL OF MEDICINE/ST. LOUIS CHILDREN’S HOSPITAL FROM 2017 TO 2023

Abstract BACKGROUND COVID-19 had a significant impact on clinical research within the healthcare system worldwide. However, there are only limited reports on its effects on clinical trials in pediatric cancer, specifically in brain tumors. We reviewed the impact of COVID-19 in the Department of Hematology and Oncology in St. Louis Children’s Hospital (SLCH). We analyzed the number of clinical trials open at our center from 2017 to 2023. We hypothesized that in 2020 there would be a significant drop in study participant enrollments at our site overall. METHODS We analyzed data from our online tracking system from 2017 to 2019, pre-pandemic, and 2020-2023, post pandemic. We will also perform a literature review of the impact COVID-19 had on clinical trial enrollment involving childhood cancers in the United States. We will compare these findings to our experience at SLCH. RESULTS In 2020, while non-therapeutic trial enrollments declined to about half of all enrollments compared to 2019, enrollments in therapeutic trials significantly increased to almost three-fold. Overall, when combining non-therapeutic and therapeutic enrollments from 2017-2020, there was a significant decrease in 2020. By 2023, total enrollments nearly recovered to pre-pandemic levels. CONCLUSIONS COVID-19 negatively impacted non-therapeutic studies at SLCH as many trials permanently closed; however, the negative effect on therapeutic studies was minimal.

DIPG-23. SAFETY AND TECHNICAL YIELD OF BRAINSTEM BIOPSIES IN CHILDREN – AN UPDATED META-ANALYSIS OF 1000 CASES

Abstract BACKGROUND Brainstem tumors represent ~10% of pediatric brain tumors, ~80% of these are diffuse intrapontine gliomas (DIPG, primarily WHO Grade 4 midline glioma, H3 K27M-mutant). Given invariably poor prognosis in these cases, there continues to be immense variation (across the US and internationally) in performing biopsy of these lesions as opposed to making a presumptive diagnosis based on MRI. Several multi-center studies in recent years have aimed to show the safety profile of biopsy but an updated meta-analysis is lacking. METHODS We found 29 studies of pediatric brainstem biopsy in the last 20 years (2003-2023), representing data from 1002 children. We applied meta-analysis of proportions using a random-effects model to generate point estimates, confidence intervals, and measures of heterogeneity. RESULTS 87% of procedures were stereotactic needle biopsies (of these, 62% with a frame, 14% without frame, and 24% robotic.) Biopsy yield (i.e. the rate at which biopsy resulted in a tissue diagnosis) was 94% (95% CI 92-97). Temporary complications were seen in 6% (95 CI 4-8), most commonly including 1) radiographic evidence of bleeding or air without an associated fixed neurological deficit, 2) cranial nerve dysfunction, and 3) delayed awakening. Permanent complications (excluding death) were seen in 1% (95% CI 0.5-2), most commonly including cranial nerve dysfunction and limb weakness. 5 deaths were reported in the entire pooled cohort of 1002 children (0.5%). Gliomas represented 92% of tumors (95% CI 89-95). Of the gliomas for which WHO grading was provided, 68% were high grade (III/IV). CONCLUSION When counseling families on the merits of brainstem biopsy in children, it is reasonable to state that permanent morbidity is rare (&amp;lt; 2%). If biopsy is performed specifically to facilitate enrollment in clinical trials requiring a molecular diagnosis, the risks of biopsy outlined here should be weighed against potential benefits of trial enrollment.

Swab Testing to Optimize Pneumonia treatment with empiric Vancomycin (STOP-Vanc): study protocol for a randomized controlled trial.

Background: Vancomycin, an antibiotic with activity against Methicillin-resistant Staphylococcus aureus (MRSA), is frequently included in empiric treatment for community-acquired pneumonia (CAP) despite the fact that MRSA is rarely implicated in CAP. Conducting polymerase chain reaction (PCR) testing on nasal swabs to identify the presence of MRSA colonization has been proposed as an antimicrobial stewardship intervention to reduce the use of vancomycin. Observational studies have shown reductions in vancomycin use after implementation of MRSA colonization testing, and this approach has been adopted by CAP guidelines. However, the ability of this intervention to safely reduce vancomycin use has yet to be tested in a randomized controlled trial. Methods: STOP-Vanc is a pragmatic, prospective, single center, non-blinded randomized trial. Adult patients with suspicion for CAP who are receiving vancomycin and admitted to the Medical Intensive Care Unit at Vanderbilt University Medical Center will be screened for eligibility. Eligible patients will be enrolled and randomized in a 1:1 ratio to either receive MRSA nasal swab PCR testing in addition to usual care (intervention group), or usual care alone (control group). PCR testing results will be transmitted through the electronic health record to the treating clinicians. Primary providers of intervention group patients with negative swab results will also receive a page providing clinical guidance recommending discontinuation of vancomycin. The primary outcome will be vancomycin-free hours alive, defined as the number of hours alive and free of the use of vancomycin within the first seven days following trial enrollment estimated using a proportional odds ratio model. Secondary outcomes include 30-day all-cause mortality and time alive off vancomycin. Discussion: STOP-Vanc will provide the first randomized controlled trial data regarding the use of MRSA nasal swab PCR testing to guide antibiotic de-escalation. This study will provide important information regarding the effect of MRSA PCR testing and antimicrobial stewardship guidance on clinical outcomes in an intensive care unit setting. Trial registration: This trial was registered on ClinicalTrials.gov on February 22, 2024. (ClinicalTrials.gov identifier: NCT06272994).

NFS-18. LOWER BODY SURFACE AREA IS ASSOCIATED WITH INCREASED LIKELIHOOD OF PLEXIFORM NEUROFIBROMA RESPONSE TO MEK INHIBITION

Abstract BACKGROUND MEK inhibitors (MEKi) are altering the management approach for plexiform neurofibroma (PN), with high rates of treatment response to multiple MEKi. Despite these successes, a subset of PN fail to respond and little is known about the clinical features associated with treatment response. METHODS We performed a retrospective cohort study integrating clinical trial data (NCT01362803, NCT02407405, NCT02096471, NCT03231306, NCT03363217) to identify baseline clinical features associated with response of PN to MEKi. Partial response (PR) was defined as ≥20 percent reduction in tumor volume from baseline. RESULTS Of 232 eligible participants, adequate clinical trial and imaging data was available for 223 participants. In the primary analysis of 184 participants with central response evaluation, the median age was 15.2 years with a median tumor volume of 488 milliliters at clinical trial enrollment. One hundred and eighteen (64%) participants achieved a PR with median time to PR of 8 cycles. Thirty-five participants (19%) required a dose reduction prior to 6 cycles of therapy due to toxicity. Younger age and lower body surface area (BSA) were significantly associated with PR in univariate analysis while female sex and typical PN appearance (versus nodular) on imaging approached significance. In multivariable analysis, only lower BSA was significantly associated with response while typical PN appearance approached significance. In the multivariable analysis of pediatric participants treated per BSA-based dosing, lower BSA was the only feature significantly associated with PR. In the expanded analysis of all 223 participants, lower BSA and typical PN appearance were significantly associated with PR. CONCLUSION Lower BSA and typical appearance of PN were associated with PR to MEK inhibitors. Future studies of MEK inhibitor for PN should integrate tumor pharmacokinetic-pharmacodynamic analyses to prospectively explore the impact of BSA on treatment response.

NURS-15. THE ROLE OF THE ADVANCED PRACTICE PROVIDER AND NURSES IN CLINICAL TRIALS

Abstract BACKGROUND For many years clinical trials fell under the umbrella of medicine without much acknowledgement to the role of the nurse, both as advanced practice provider (APP) and staff nurse. Oncology continues to rank as one of the highest subspecialties when it comes to availability and participation in clinical trials. There remain multiple barriers to involvement including availability, lack of education, and medical mistrust. The specialized role and skill set of the APP and RN as part of the clinical trial team is important in overcoming these barriers. METHODS We distributed a survey to members of the Advanced Practice Provider and Nurse Investigator Committee (APPNIC), a group within the Pediatric Neuro-Oncology Consortium (PNOC), in order to identify themes, barriers to care, and opportunities for both the APP and RN within clinical trials. The use of a survey and interviews within our APPNIC cohort allowed us to collaborate on the nursing role, prioritize care in new and amended trials, and share unanticipated adverse effects and effective management. RESULTS APPs are actively involved with clinical trial enrollment, performance of diagnostic exams and procedures, education, and early recognition/management of adverse effects. There is also a growing theme of the APP as sub-investigator which provides value in facilitating consent, impacting accrual, determining eligibility, managing anticipated side effects. The role of the staff nurse in clinical trials is found to be vital in providing consistent communication/support, educating patients and families, and alleviating adherence and medical mistrust. CONCLUSION The APP and nurse have a specialized, relevant skill set, which when included as part of the multi-disciplinary team, has the ability to decrease barriers and increase overall delivery and safety of clinical trials. Our goal is to outline specific roles we feel should be standardized in the international arena for nursing involvement within clinical trials.

Current and anticipated future state of cachexia care in patients with cancer.

Aims: We assessed care in cancer patients with cachexia across leading health systems (LHSs).Patients & methods: Qualitative interviews and quantitative surveys were conducted with LHSs executives and frontline health care personnel, representing 46 total respondents and 42 unique LHSs and including oncology service line leaders, supportive care services, dietitians and surgical oncologists.Results: Cachexia was not considered a top priority, and formal diagnoses were rare. Participants highlighted the importance of addressing barriers to increase clinical trial enrollment and support frontline health care personnel and patients in early detection of cachexia.Conclusion: Cachexia prioritization needs to be elevated across LHSs executives to obtain capital and strategic imperatives to advance related care.

Simplifying informed consent as a universal precaution

One barrier to participating in clinical research is that patients with low literacy skills (1 in 5 US adults) may struggle to understand the informed consent document (ICD). Writing consents using health literacy and plain language guidelines including simplified syntax and semantics can increase understandability and facilitate inclusivity of research populations with literacy challenges. Our study aim was to evaluate a simplified ICD for understandability while considering factors known to relate to comprehension (reading skills and working memory). We performed an on-line survey of 192 adults ages 18–77 in Georgia. Participants performed significantly better on the simplified ICD test. We built an additional model with all version x measure interactions (i.e., age, sex, race, urbanicity, GMVT, WM). This model did not significantly improve model fit, F < 1.00, suggesting that individual differences did not moderate the effect of simplification. Our findings suggest that using plain language and simplified syntax and semantics in ICD as a universal precaution may reduce cognitive reading burden for adults regardless of differences in reading skill or working memory. Increasing understandability in ICD may help improve targets for clinical trial enrollment.

Administration of 4% tetrasodium EDTA lock solution and central venous catheter complications in high-risk pediatric patients with intestinal failure: A retrospective cohort study.

Selection of central venous catheter (CVC) lock solution impacts catheter mechanical complications and central line-associated bloodstream infections (CLABSIs) in pediatric patients with intestinal failure. Disadvantages of the current clinical standards, heparin and ethanol lock therapy (ELT), led to the discovery of new lock solutions. High-risk pediatric patients with intestinal failure who lost access to ELT during a recent shortage were offered enrollment in a compassionate use trial with 4% tetrasodium EDTA (T-EDTA), a lock solution with antimicrobial, antibiofilm, and antithrombotic properties. We performed a descriptive cohort study including 14 high-risk pediatric patients with intestinal failure receiving 4% T-EDTA as a daily catheter lock solution. CVC complications were documented (repairs, occlusions, replacements, and CLABSIs). Complication rates on 4% T-EDTA were compared with baseline rates, during which patients were receiving either heparin or ELT (designated as heparin/ELT). Patients initiated 4% T-EDTA at the time they were enrolled in the compassionate use protocol. Use of 4% T-EDTA resulted in a 50% reduction in CVC complications, compared with baseline rates on heparin/ELT (incidence rate ratio: 0.50; 95% CI, 0.25-1.004; P = 0.051). In a compassionate use protocol for high-risk pediatric patients with intestinal failure, the use of 4% T-EDTA reduced composite catheter complications, including those leading to emergency department visits, hospital admissions, additional procedures, and mortality. This outcome suggests 4% T-EDTA has benefits over currently available lock solutions.

Sex, racial, and ethnic disparities in motor neuron disease: clinical trial enrolment

Objective Motor neuron disease (MND) is a group of neurological diseases, the majority being amyotrophic lateral sclerosis (ALS), with varying clinical presentations across demographics. Clinical trial enrollment reflecting global disease burden improves understanding of diverse presentations and aids personalized therapy development. We assessed the sex, racial, and ethnic composition of MND/ALS clinical trial participants relative to global disease burdens. Methods We searched ‘motor neuron disease OR amyotrophic lateral sclerosis’ on ClinicalTrials.gov from 02/2000–04/2024. We extracted trial (start year, study site, sponsor location, phase, masking, intervention) and demographic data (sex, race, ethnicity) from randomized interventional studies. We obtained sex-based MND/ALS disease burden estimates from the Global Burden of Disease database. For females, we calculated pooled participation-to-prevalence ratio (PPR) with 95% confidence intervals (CIs), with PPR of 0.8–1.2 indicating adequate enrollment. We used Kruskal–Wallis tests to compare demographic groups across trial characteristics. Results Of 85 trials, females comprised 37.47% (n = 5011) of 13,372 participants; the pooled female PPR was 0.97 (95% CI: 0.77–1.16). Of 41 trials (9340 participants) reporting race, 121 (1.30%) participants were Black or African American, 16 (0.17%) American Indian or Alaskan Native, and 6 (0.06%) Native Hawaiian or Other Pacific Islander. 24 trials (595 participants) reported ethnicity, with a minority of Hispanic participants (n = 153; 2.57%). Conclusions MND/ALS clinical trials had adequate female enrollment relative to global disease burdens. Race and ethnicity data were underreported. However, there were enrollment disparities of racial and ethnic groups. Increased trial leadership diversity, equitable enrollment policies, and addressing barriers to participation could improve enrollment diversity.

Association of patient-reported experience of care with cancer clinical trial participation.

11117 Background: Few individuals diagnosed with cancer participate in clinical trials. Patient-reported experience of care (PEC), assessing patients’ perspectives on interactions with healthcare providers and systems, is important in evaluating quality of care. To help identify patient-centered strategies that may enhance trial enrollment, we examined whether PEC may predict enrollment in clinical trials. Methods: This study utilized Surveillance, Epidemiology, and End Results-Consumer Assessment of Healthcare Providers and Systems (SEER-CAHPS) linked data, including SEER registry data, CAHPS PEC surveys, and Medicare claims. Individuals in SEER-CAHPS who were diagnosed with lung cancer 2000-2018 and completed a CAHPS survey ≥6 months following diagnosis were included. The study outcome, clinical trial enrollment after cancer diagnosis, was determined using Medicare claims; among individuals who enrolled in clinical trials, only those completing a CAHPS survey before trial enrollment were included. PEC was assessed using 5 global ratings (Overall Care, Personal Doctor, Specialist, Health Plan, and Prescription Drug Plan) and 6 composite measures (Doctor Communications, Getting Needed Care, Getting Care Quickly, Getting Needed Drugs, Care Coordination, and Customer Service); all were scored 0 (worse PEC) to 10 (best PEC). Associations of trial participation and PEC were assessed using multivariable logistic regression, controlling for age, race/ethnicity, dual Medicaid status, fee-for-service vs Medicare Advantage plan at diagnosis, and physical problems limiting activities, and were weighted to correspond to the overall SEER population. Results: The study included 5,361 individuals diagnosed with lung cancer; 4.8% of the weighted population enrolled in a clinical trial. Patients with higher PEC ratings for their Specialist (odds ratio [OR] for a 1-point higher PEC score 0.86, 95% CI 0.76, 0.98); for their Health Plan (OR 0.87, 95% CI 0.80, 0.96); and for Getting Needed Care (OR 0.89, 95% CI 0.81, 0.98) had significantly (p&lt;0.05) lower oddsof having enrolled in a clinical trial. Among individuals without physical limitations, association of PEC and trial enrollment were similar. Among individuals with physical limitations, higher PEC ratings for Getting Care Quickly were associated with higher odds (OR 1.20, 95% CI 1.03, 1.39) of having enrolled in a trial. Conclusions: In this population, reporting worse PEC in certain domains was significantly associated with increased clinical trial enrollment. This suggests patients less happy with their clinical care may be more likely to enroll in trials, perhaps to receive different types of care and/or from different providers. PEC associations with trial enrollment differ between patients with vs without physical limitations, suggesting different strategies may be effective for increasing trial enrollment among these two sub-groups.

Predicting therapeutic clinical trial enrollment for underrepresented patients in neuro-oncology using supervised machine learning.

1614 Background: Despite the unique ability of machine learning (ML) techniques to uncover complex interactive effects in datasets, studies exploring predictors of clinical trial enrollment have largely used standard statistical methods to discern associations. Furthermore, there have been limited applications of ML to close existing disparities in clinical trial enrollment of underrepresented patients in neuro-oncology. This study aims to use supervised machine learning to define and validate primary contributors of therapeutic clinical trial enrollment for a) all patients, b) women and c) NIH-designated minority patients with low- and high-grade glioma. Methods: Adult glioma patients who received care from the UCSF Brain Tumor Center between 1997- 2017 were identified in a prospective registry. Bootstrap forest (BF) and Recursive Partitioning (RP) models were created by randomly dividing patients in a 70/30 split into development (DEV) and validation (VAL) cohorts among all patients, women, and NIH-designated minority patients, separately. Model performance was assessed using the area under the curve (AUC) in the DEV and VAL cohorts. Results: Among 1042 patients, 350 patients (33.6%) enrolled in a therapeutic clinical trial. There were 445 women (42.7%), of which 144 (32.4%) enrolled, and 141 minority patients (13.5%), of which 39 (27.7%) enrolled. For all patients, in order of decreasing influence, the BF model selected median neighborhood household income, age, neighborhood poverty level, distance from hospital, tumor location, tumor volume, treatment with chemotherapy, occupation, KPS, insurance status, employment status, seizure at presentation, and volumetric extent of resection (EOR) to predict trial enrollment (DEV AUC: 0.984; VAL AUC: 0.746). For women, the BF model selected distance from hospital, age, household income, neighborhood poverty level, tumor location, treatment with chemotherapy, and KPS for trial prediction (DEV AUC: 0.972; VAL AUC: 0.746), whereas for minority patients, the BF model selected neighborhood poverty level, age, occupation, distance from hospital, tumor volume, insurance status, employment status, and EOR to predict trial enrollment (DEV AUC: 0.9830; VAL AUC: 0.769). The RP model for women designated those with non-White race as less likely to enroll (DEV AUC: 0.735; VAL AUC: 0.665) while the RP model for minority patients characterized those who preferred a non-English language or who were divorced or widowed as less likely to enroll (DEV AUC: 0.775; VAL AUC: 0.601). Conclusions: Supervised machine learning models achieved similar predictive performance among patient subgroups, while uncovering interactions between gender identity, minority status, and sociodemographic variables. These findings can guide targeted recruiting efforts to advance equitable trial enrollment for women and minorities.

PENTAGON (Predicting Clinical Trials in Gynecologic Oncology): A retrospective study assessing study design factors that affect enrollment in gynecologic cancer trials.

e13647 Background: Obstacles to attaining a diverse clinical trial population contribute to poor representation in medicine, increasing health disparities by limiting generalizability and applicability of findings. Our objective is to evaluate trial enrollment trends according to patient and trial demographics for those who have sought care at our multi-center, mixed-setting Gynecologic Oncology practice. Additionally, we aim to determine specific trial criteria that promote or impede enrollment for patients and physicians. Methods: An IRB-approved, retrospective cohort study evaluating all patients who screened positive for a clinical trial through the Gyn Onc practice’s manual screening process was performed. Screening events were new neoplasms, recurrences or progressions, and changes in treatment. Data was collected from July 2022 to December 2023. Demographic information, trials for which each patient was considered, trials patients enrolled on, and trial characteristics were recorded. Results: After adjustment, there were no significant differences between patient factors (age, marital status, race, ethnicity, and number of screening events) and enrollment status. Of trials available, 9% require biopsy and 94.7% are in person. Most studies are interventional (78.9%) and pharmaceutical trials (73.7%). There was a drastic unadjusted estimated increase in enrollment for Medicaid patients compared to other insurances (55.2% vs 32%, p=.031). There was also an increase in enrollment for cervical cancer patients (18.4%, p=.106) compared to other cancer sites (56.5% vs 32.8%, p=.036). There was a positive relationship between distance traveled to the treatment site and clinical trial enrollment. Patients who lived within 20 miles of the clinical trial site had an enrollment percentage of 30.1% (n=93), compared to 46.55% enrollment for those who lived further (n=58). There was a significant increase in enrollment likelihood without an exclusion criterion of previous history of other cancer (50% vs 33.3%, p=.046). Trials that required no history of chemotherapy had an enrollment of 27.3% (compared to 44.1%). Conclusions: Unlike prior reports, we did not demonstrate differences in trial enrollment by race, socioeconomic or insurance status. This suggests that our objective manual screening process enhances equitable clinical trial offerings. It is possible that this objective manual screening process attenuates provider bias and offers clinical trials to historically marginalized and underrepresented groups.

Healthcare disparities are associated with eligibility and enrollment in clinical trials in Louisiana.

e13728 Background: Clinical trials offer an opportunity to evaluate novel therapeutic strategies and modalities of care. Overall enrollment is low for clinical trials, but previous literature has highlighted lower rates of enrollment among underrepresented populations. A disproportionately low accrual of minority or other populations will result in reducing the ability of such clinical trials to prove general benefit to the overall population. This study aims to evaluate the population of those able or unable to qualify for and enroll in the Gulf South Clinical Trials network, a minority/underserved NCORP community site. Methods: Patient data was collected through interviews using a screening tool developed by the National Cancer Institute’s Community Oncology and Prevention Trials Research Group and active enrollment of ongoing clinical trials. Patients were interviewed regarding demographic data and tumor staging. Reason for ineligibility or non-enrollment was documented by the clinical staff. Clinical trials were categorized between Cancer-Control and Cancer Care Delivery Research (CC-CCDR) Trials and Cancer Treatment Trials from 2017 and 2023. Rates of eligibility and enrollment were compared via Fisher’s Exact tests. Results: CC-CCDR Trials had 363 participants while Cancer Treatment had 550 participants. CC-CCDR Trials resulted in 19% (n=69) of patients being ineligible with 81% (n=294) being eligible with a higher proportion of Whites (p&lt;.001), non-rural (p = .021), low income (p=.007), private insurance (p=&lt;.001), stage 1 tumors (p&lt;.001), and having a genetic predisposition (p&lt;.001) being ineligible. From the patients that were eligible, 13% (n= 39) of patients were not enrolled with 87% (n=255) of patients enrolled. Cancer Treatment Trials resulted in 23% (n=129) of ineligible patients and 76.5% (n=421) of eligible patients, with a higher proportion of low income (p=.002), private insurance (p=.035), and those not having genetic predispositions (p=.022) being ineligible. From the participants that were eligible, 20% (n=85) of patients were not enrolled with 80% (n=336) of patients enrolled, with a higher proportion of female (p= .002) patients not enrolled. Conclusions: Disparities in socioeconomic factors and female gender are associated with lower rates of eligibility and enrollment in clinical trials in community oncology settings. Future research identifying modifiable underlying factors can assist in developing strategies to improve enrollment in underserved populations.

Investigating disparities in enrollment of patients in lung cancer clinical trials that led to FDA approval for immunotherapies between 2015 and 2023: A comparison with the US population.

e23104 Background: Registrational clinical trials have led to the FDA approval of numerous immunotherapy (IO) agents in the treatment of non-small cell lung cancer (NSCLC) since 2015. Given the historical lack of adequate representation of the US population with cancer in clinical trials, we aimed to analyze disparities in race and ethnicity reporting and enrollment in lung cancer clinical trials that led to FDA-approved immunotherapies between 2015-2023. Methods: The FDA archives and database were queried to review all FDA drug approvals for IO approved to treat NSCLC between 2015 to 2023. Enrollment data were obtained from FDA labels, ClinicalTrials.gov, and corresponding journal manuscripts. The enrollment incidence ratio (EIR) and enrollment mortality ratio (EMR) were calculated as the proportion of patients of a particular race among clinical trial participants in approval studies divided by the estimated proportion of patients of that particular race diagnosed or dying of lung cancer, respectively, among the US population. Results: Among 27 trials with a total of 15,878 subjects, distribution by race shows that 77.5% were White, 16.7% Asian, 8.8% Hispanic, 1.63% Black, 0.33% American Indian Alaska Native (AIAN), and 0.07% were Native Hawaiian and Other Pacific Islander (NHOPI). 67.4% were males while 32.6% were females. The EIR for Non-Hispanic White, Non-Hispanic Black, Asian, and Hispanic patients was 0.99, 0.13, 3.56, and 0.85 respectively. The EMR for Non-Hispanic White, Non-Hispanic Black, Asian, and Hispanic patients was 0.99, 0.12, 4.23, and 0.96 respectively. Racial demographics were reported in 65% of journal manuscripts, 65% of ClinicalTrials.gov pages, and 92% of FDA labels while ethnicity demographics were reported in 0% of journal manuscripts, 42% of ClinicalTrials.gov pages, and 15% of FDA labels. Conclusions: Black, AIAN and female patients are severely underrepresented in lung cancer trials that lead to approval for IO based therapy. Asian patients were overrepresented. Less than half of the trials reported data on ethnicity. Further research is needed to see if regulatory initiatives to increase clinical trial diversity result in more equitable clinical trial enrollment in pivotal trials.