bluuebunny/crossref_metadata_2025_split huggingface dataset:
Patterns of diversity in cancer clinical trial enrollment at a New York City academic health system, 2018-2022.
Authors: Rodriguez-Russo Carlos , Chadha Manjeet , Cocco Jennifer , Goodman Karyn A. 
Published: June 2023

e18630 Background: Mitigation of cancer clinical trial (CT) enrollment disparities is increasingly prioritized in healthcare, but disparity metrics are inconsistently published by individual health systems. We aimed to assess health-system-level trends in CT enrollment by race, ethnicity, sex, and treatment location (network vs main hospital) during the COVID-19 pandemic, as well as to evaluate county-level disparities in CT accrual fraction (AF) over a five-year period. Methods: This was a cross-sectional study of the population enrolled on therapeutic cancer CTs in a New York City academic health system (AHS) from 2018-2022. Demographics were descriptively analyzed and compared with most recent public NCI-reported therapeutic trial accrual data. New York County 5-year cancer incidence was estimated for each demographic subgroup using age-adjusted cancer incidence rates from public SEER/NPCR data and US Census data. Primary endpoint was AF, defined as proportion of patients accrued relative to cancer incidence. Results: Of 2,533 patients enrolled on CTs over the 5-year period, 51% were White, 18% Black, 17% Hispanic, 9.8% Asian, 0.08% American Indian/AK Native, 0% Pacific Islander, and 3.9% Multiple/unknown race; 47% were female. Minority accrual proportion was higher than that of NCI accrual data (45% vs 25%, p =< 0.001). Annual enrollment fell from maximum 571 patients in 2019 to 457 in 2020, then increased to 499 by 2022. Meanwhile, the proportion of minority enrollment increased to a peak of 49.2% in 2020 and fell to 45% in 2022. Female enrollment of 49% in 2018 decreased to 42% in 2021, increasing sharply to 51% in 2022. On multivariate analysis, Black and Asian patients were more likely to be enrolled after the start of the pandemic than White patients (ORs 1.3, 95% CI 1.1-1.6; 1.4, 1.03-1.8). Black, Asian, and female patients were more likely to be enrolled at network hospital locations than White or male patients, respectively (ORs 1.9, 95% CI 1.3-2.7; 2, 1.2-3.1; 14, 8.6-21). Relative to county-level estimated cancer incidence, Black patients had a higher AF than White patients (0.96% vs 0.77%, OR 1.3, 95% CI 1.1-1.4), while Hispanic patients had a lower AF (0.55%, OR 0.72, 95% CI 0.64-0.8). Women had a lower AF than men (0.66% vs 0.74%, OR 0.9, 95% CI 0.83-0.97). Conclusions: Minority accrual at this AHS was higher than nationally reported. Despite decreased total accrual numbers in 2020 due to the COVID-19 pandemic, high accrual diversity was maintained. County-level AF disparities among women and Hispanic patients suggest opportunities for improvement in community outreach, and greater diversity of clinical trial enrollees at network hospitals may reflect successful outreach to the communities they serve.
Barriers to implementing expanded access programs in oncology: A multidisciplinary perspective.
Authors: Fu Sherry , Muquith Maishara , Williams Erin Fenske , Anderson, Jr Larry D. , Zhang Tian , Beg Shaalan 
Published: June 2023

e18632 Background: Expanded access (EA) is a pathway to make investigational drugs available to patients in need but who are unable to join a trial. Despite the rapid approval time for expanded access requests by the Food and Drug Administration, EA protocols ( > 1 patient) and single-use EA have limited utilization due to barriers affecting physicians, pharmacists, and clinical research office staff. We examined factors limiting the broad implementation of EA at an NCI-designated comprehensive cancer center. Methods: Semi-structured interviews were conducted with oncologists (5), pharmacists (2), and research operations leadership (1) involved with applying for and facilitating expanded access at our institution. Interviews were transcribed verbatim and grouped into themes by 2 independent coders. Results: At our institution, recent EA requests for adult patients with cancer involved anti-viral and CAR-T therapies. Participants agreed that increased EA utilization benefits patients and potentially the institution, provided the workflow is not burdensome. Major barriers include gaps in physician knowledge of institutional processes and lack of response from drug sponsors on ability to supply drug. For EA protocols ( > 1 patient), there was lack of reimbursement for time and resources, particularly for regulatory coordination and pharmacy services, which often competed with clinical trial needs. EA requests are part of standard clinical care but may require reporting patient-level data to sponsors and resources similar to a clinical trial. This contributes to unclear delineation of roles between research and clinical staff, which delays communication with the pharmacy and adverse event reporting to sponsors. Across all departments, there was a desire for a centralized office or dedicated individual to support EA processes. Conclusions: Oncology professionals recognize the benefit of EA for patients with cancer. However, utilization is limited by various challenges including lack of clearly defined roles and financial support. Suggested improvements include establishing a centralized resource at the institutional level to streamline workflows. External parties such as industry, payers and advocacy groups can also enhance EA activity through defined protocols and resources for administrative support.
Rural communities and health professional shortage areas (HPSA) and access to immune effector cellular therapy and lymphoma/myeloma clinical trials.
Authors: Ahmed Nausheen , Wesson William , Pal Mudaranthakam Dinesh , Mushtaq Muhammad Umair , Abdallah Al-Ola A. , Lutfi Forat Umair , Baranda Joaquina Celebre , Abhyankar Sunil H. , McGuirk Joseph , Hoffmann Marc 
Published: June 2023

e18633 Background: The National Health Service Corps (NHSC) has created a shortage designation to identify medically underserved communities. HPSA (Health Professional Shortage Areas) designation identifies an area, population, or facility with inadequate access to healthcare resources such as primary care. Rural-urban continuum codes (RUCC) classify U.S. census tracts using urbanization, population density, and daily commuting. Additionally, there are racial, ethnic, and geographic disparities in enrollment on therapeutic cancer clinical trials. Chimeric antigen receptor T cell (CAR T) therapy has been at the forefront of immune effector cell therapy (IEC) for lymphoma and myeloma. However, it is delivered at specialized centers, and access to specialty centers is known to be a challenge due to financial and geographic barriers. At our institution, trials for CAR-T cell therapy in lymphoma and myeloma are conducted by the IEC disease working group (DWG), while non-IEC trials are conducted by the lymphoma/myeloma DWG. We hypothesized that patients from HPSA and rural communities and HPSA had lower access to IEC and non-IEC trials for lymphoma and myeloma . Methods: Patients enrolled between 1/1/2015 – 2/6/2023 on IEC and non-IEC interventional trials with treatment were included. Disease types included lymphoma (Follicular lymphoma, high-grade B cell lymphoma, diffuse large B cell lymphoma) and myeloma were included. The hypothesis was tested through a t-test. Results: There were 667 total subjects. 503 (75.4%) were non-IEC and 96 (14.3%) were IEC clinical trial participants. The majority in both groups were male (52.7%), White (74.8%), non-Hispanic (86%) .Only 69 (10.3%) pts were from rural areas and 223 (38.9%) were from HPSA communities When stratifying based on RUCC (Table), there is significantly higher rural accrual for IEC trials compared to non-IEC trials. Hispanics from rural areas were lower. There were no African Americans (AA) from rural areas. Conclusions: There is low representation of patients from HPSA and rural communities for IEC and non-IEC lymphoma and myeloma clinical trials. The ethnic and racial inequity in access and enrollment to lymphoma/myeloma trials are pronounced in rural and HPSA communities. Strategies to improve clinical trial enrollment of the underserved rural and HPSA populations is an area of unmet need and will benefit minorities and patients from lower socioeconomic status. [Table: see text]
The impact of novel therapies on disparities in survival outcomes for metastatic cancers.
Authors: Degeling Koen , Zebrowska Karolina , Banuelos Rosa C. , Rizzo Evelyn J. , Belk Kathy W. , Schneider Gary 
Published: June 2023

e18635 Background: Real-world data have suggested that increases in overall survival (OS) for metastatic cancers over time have been driven by improvements in the groups of patients who already had the highest survival outcomes. To further investigate these identified trends, this research aimed to quantify how novel therapies for metastatic cancers impact disparities in OS outcomes. Methods: Novel therapies for metastatic breast (mBC), metastatic colorectal (mCRC), and metastatic non-small cell lung (mNSCLC) cancer, approved by the United States Food and Drug Administration (FDA) in the last 8 years based on data from phase III randomised controlled trials (RCTs), were identified. For each cancer type, 3 novel therapies were selected with inclusion based on the availability of published Kaplan-Meier data for OS, at least 100 patients in each arm of the corresponding RCT, and OS reaching less than 30% at the end of the RCT follow-up period. For each cancer type and for the novel therapies and comparator therapies separately, the published OS data were replicated from the Kaplan-Meier data and pooled using weights based on sample sizes to ensure each therapy contributed equally to the analysis. Parametric survival modelling was performed to address censoring. The disparity in OS was defined by the absolute difference between groups with the highest and lowest survival, with groups defined by stratifying OS in either 2 or 5 groups. The impact of the combined novel therapies was determined based on the change in OS disparity relative to the combined comparators. A probabilistic analysis was performed to quantify the impact of parameter uncertainty on the outcomes. Results: Novel therapies increased disparities in OS across the 3 cancers. For mBC, the disparities in OS increased by 5.4 (95%-confidence interval: 0.9; 9.9) months, which equates to a 23.0% increase from 24.2 to 29.6 months if OS was stratified in 2 groups, and by 13.9 (1.4; 26.6) months; 25.0% from 57.1 to 71.1 if OS was stratified in 5 groups. For mCRC, disparities increased by 2.8 (1.4; 4.2) months; 37.6% from 7.5 to 10.3 months and by 6.3 (2.9; 9.8) months; 38.9% from 16.5 to 22.8 months, for stratification based on 2 and 5 groups, respectively. For mNSCLC, disparities increased by 10.2 (3.3; 17.3) months; 33.6% from 31.0 to 41.3 months and by 19.5 (4.0; 35.5) months; 31.5% from 63.2 to 82.7 months, for stratification based on 2 and 5 groups, respectively. Conclusions: OS outcomes for recent FDA-approved drugs for metastatic cancers suggest that these novel therapies increase disparities in OS between the patient groups with the highest and lowest OS relative to their comparator therapies in RCTs. Although evidence in terms of these disparities is important, further research using (real-world) individual patient data is warranted to assess how, for example, socioeconomic variables affect the impact of therapies on health disparities among patient groups.
Repetitive presentations of phase II and III trials involving systemic therapies in gastrointestinal (GI) malignancies at international meetings in the past few years.
Authors: Barbosa Malu , Ferreira Artur Rodrigues , Coelho Ricardo Lima , Muniz Pamela Carvalho , Souza Camila Brambilla , Neto José Ap. Tristão , Cascelli Fanny , Costa e Silva Matheus , Peixoto Renata D'Alpino 
Published: June 2023

e18638 Background: The American Society of Clinical Oncology (ASCO) and the European Society of Medical Oncology (ESMO) annual meetings as well as their GI dedicated meetings (ASCO GI and ESMO GI) have the premise to accept abstracts for oral presentations that have not been previously presented. Methods: We conducted a review of all 220 abstracts involving phase II or III trials of systemic therapies that have been presented orally from June 2019 to January 2023 at ASCO, ASCO GI, ESMO and ESMO GI meetings to evaluate the incidenceof repetitive presentations of the same trial in different meetings as well as their relationship to pharmaceutical industry sponsorship. ANOVA test was used to compare means between different groups and p values of ≤ 0.1 were considered significant. Results: Overall, 20,9% of accepted oral abstracts from phase II or III trials were replicated during the 4-year time frame. Of them, 39% were phase II, 61% phase III, 72% pharma sponsored, 39% included developing countries, and 59% were positive. The association of industry sponsorship and study positivity indicated a variation of up 3,55 appearances (p 0,017) in the number of times this research was orally presented. Conclusions: Our findings suggest that almost 20% of oral abstracts involving systemic therapies in GI cancers are presented more than once at relevant meetings, especially those with positive results and sponsored by pharma. Our study highlights the need for a more effective oral abstract selection system in oncology meetings.
Barriers and facilitators to enrolling in a cancer clinical trial financial reimbursement program.
Authors: Nguyen Vivian , Ramos Elizabeth , Dornsife Dana , Johnson Robert G. , Miller Erin , Jones Mallorie , Uribe Daniela , Wileyto E. Paul , Vonderheide Robert H. , Guerra Carmen 
Published: June 2023

e18641 Background: Cancer clinical trial (CCT) participants often have significant out-of-pocket expenses. These expenses may disproportionately burden lower income participants. To increase access to CCTs, the Lazarex Cancer Foundation (LCF) created the Improving Patient Access to Cancer Clinical Trials (IMPACT) Program, a financial reimbursement program for out-of-pocket travel and lodging expenses. This study was designed to evaluate the barriers and facilitators to enrolling and participating in the IMPACT Program. Methods: This qualitative study consisted of semi-structured interviews with a subset of CCT participants at the Abramson Cancer Center (ACC) of the University of Pennsylvania who enrolled in the IMPACT Program and consented to this study. The interview focused on barriers and facilitators of enrolling in the program and suggestions for improving enrollment. The interviews were analyzed using grounded theory methods of analysis. Results: From May 2021 to January 2023, 75 patients enrolled in the program and 31 patients participated in the interview (57% Female, 93% White, Median Age (SD) = 66.0 years (13.6)). The most common cancers represented in this population were hematological, gastrointestinal, and breast cancers (37.3%, 16.0%, and 13.3%, respectively). The table shows the reported barriers and facilitators of enrolling in IMPACT. The most commonly cited barriers were related to the process of enrollment (participants wished to be contacted earlier before accruing expenses) and patient barriers (technology access and privacy concerns). The most common facilitator to enrollment was receiving assistance and explanation from ACC IMPACT coordinators. Participant suggestions for improving enrollment in IMPACT include earlier introduction of the program to potential clinical trial participants during the informed consent process and offering navigation services for cancer center resources. Conclusions: Out-of-pocket expenses related to clinical trials can be addressed through financial reimbursement programs. To optimize the benefit of these programs, it is ideal to enroll patients at the time of informed consent, establish IMPACT coordinators, and use technology to streamline the enrollment and submission process. [Table: see text]
Faith-based communities’ preferred interventions to improve the participation of black/African-American persons in medical research and clinical trials: A focus group study.
Authors: Hurwitz Heather McKee , Combs Pamela , Ribbins Mark , Nguyen Minh-Tri , Sanders Kimberly 
Published: June 2023

e18648 Background: A variety of interventions within faith-based and medically underserved communities have been utilized to increase racial/ethnic minorities’ participation in health programming and clinical trials. However, the literature lacks studies on which interventions are preferred by church members and leaders to address disparities in clinical trials. Methods: The study utilized focus groups to understand participants’ knowledge and attitudes about medical research/clinical trials and to develop and appraise interventions for and in collaboration with members and leaders of predominately Black/African American faith-based organizations. Participants were recruited by convenience and snowball sampling from organizations involved in the Cleveland Clinic Taussig Cancer Center Community Outreach program’s faith based model called, Stopping Cancer In Its Tracks (SCIIT). Study personnel conducted 6 focus groups at 6 different churches from June through August 2022. Results: 30 participants joined the study. Conversations lasted 90-120 minutes and covered a range of topics. Each group included deep, cathartic sharing about disparities in accessing medical/cancer care and racism, particularly within medicine. Participants explained that low enrollment among Black/African-Americans in clinical trials is a result of everyday and structural racism. Also disparities are linked to the compounded, long-term lack of beneficence or human rights within research and health care for their communities. Accordingly, diversity in clinical trials may improve by creating interventions that address distrust, communication, and information and access gaps, and are tailored to each church. Preferred interventions should: 1) Embody a deep, long-term, relationship-building process. 2) Focus on creating trust by sharing in church services/activities/meals/two-way conversations/cancer screenings. 3) Leverage testimonials from cancer survivors who have participated in clinical trials. The focus groups themselves were felt by participants to be an example of the trust building and knowledge sharing necessary to address disparities. Participants expressed interest to develop interventions in partnership with the study personnel of health care workers. Conclusions: The study fills a gap in the literature by analyzing and amplifying the ideas of Black/African-American church members and leaders from medically underserved communities who generally have been excluded from research. Participants preferred interventions that feature long-term relationship building and engagement. Future research should implement and test the effectiveness of these interventions.
Differences in racial and sex at birth representativeness between randomized controlled trial (RCT) and real-world evidence (RWE) or Surveillance, Epidemiology, and End Results (SEER) datasets in advanced non-small cell lung cancer (aNSCLC).
Authors: Savill Kristin M. Zimmerman , Gentile Danielle , Asgarisabet Parisa , Brown Madison , Chopra Dhruv , John William S , Swain Richard Scott , Klink Andrew J. , Feinberg Bruce A. 
Published: June 2023

e18654 Background: Historically, racial and ethnic minorities, women, and older patients have been underrepresented in RCTs. Hence, therapeutics are approved based on data not representative of the broader population, leaving important gaps in knowledge of safety and effectiveness. RWE may help address these gaps and inform regulatory, clinical, payer, and manufacturer decision-making. Racial, sex at birth, and age distributions were compared between RWE studies and a corresponding RCT in the aNSCLC setting. Additionally, RCT data were compared to SEER aNSCLC data. Methods: Demographics of adults with aNSCLC in the KEYNOTE-407 RCT were compared with those of adults in two physician-abstracted medical chart review US RWE studies conducted in 2019 or 2020 or with the most recently available US SEER data (2017-2019). Statistical comparisons were performed using t-tests or chi square tests. Results: We identified 10,089 patients (RCT: n = 559, 5.5%; RWE: n = 783, 7.8%; SEER: n = 8,747, 86.7%) (Table). Significant differences in racial distribution were observed between the RCT and RWE study populations, with Black/African American patients comprising 1.3% of RCT patients and 24.0% of the RWE study population. Non-Hispanic Black patients made up 12.8% of SEER patients. The proportion of female patients was lower in the RCT (18.6%) compared with RWE (40.5%) and SEER (36.7%) data. Age at 1L initiation was significantly lower for RCT patients vs. age at metastatic diagnosis in SEER (mean: 64.7 vs. 70.0 years). However, no statistically significant difference in age at 1L initiation was observed between RCT and RWE data (64.9 vs. 64.7 years). Conclusions: In aNSCLC, significant differences in sex at birth and race were observed between RCT and RWE study populations. Additionally, significant differences in sex at birth and age were observed between RCT and SEER data. Given that regulatory, therapeutic development, clinical, payer, and decision-making is largely driven by data from RCTs, future research can leverage RWE to improve representativeness and generalizability. [Table: see text]