"Why I Said No": Trial-Eligible Patient Perspectives on Declining Breast Cancer Clinical Trial Participation.

Diversity and Inclusion in Pancreatic Cancer Clinical Trials

Mitigating Administrative Risks in Industry-sponsored Clinical Trials

Distance to Care Predicts Clinical Trial Enrollment on COG ALL Clinical Trials: A Report from the Children's Oncology Group

AIDS Clinical Trials Is There Access for All?

AIDS clinical trials. Is there access for all?

Purpose: Thirty years after the NIH Revitalization Act, racial/ethnic minority (REM) patients continue to be underrepresented in oncology clinical trials with disproportionately low rates of participation compared to non-Hispanic whites. Health system, patient, and medical provider factors contribute to this disparity. However, little is known about clinical trial investigator perspectives of REM participation in oncology clinical trials and their contribution to this disparity. To our knowledge there are no published quantitative studies that have investigated this important and actionable topic. Methods: We conducted a cross-sectional, anonymous, pilot survey of medical, radiation, and surgical oncology clinical trial investigators at a large academic center. Over a 5-week period, 107 individuals received a survey. The survey assessed 6 domains regarding disparities in REM participation in clinical trials: investigator knowledge, attitudes, and prior training on the topic, self-efficacy and motivation for improvement in addressing known disparities, and perceived barriers to REM participation in clinical trials. Modified, previously validated items were used when possible. Results: Of 60 respondents (56% response rate), 33 were male (55%). Thirty-six identified as non-Hispanic white (60%), 16 as Asian (27%), 1 as Hispanic/Latinx (2%), and 7 as other/prefer not to state (11%). Respondents included 49 medical (82%), 7 surgical (11%), and 4 radiation oncologists (7%). Average time as a clinical trial investigator was 14 years (2-40). Respondents opened an average of 2 clinical trials as primary investigator in the past year (0-10). A majority (83%) strongly agreed disparities exist in REM clinical trial participation and that the resulting lack of diversity is problematic (75%). However, only 34% strongly agreed they consider ways to achieve racial/ethnic diversity among trial participants when designing clinical trials, or ways to specifically enroll REM patients (28%). Respondents most commonly cited patient rather than health system factors as barriers to REM participation in clinical trials. Notably, nearly half (45%) agreed that lack of REM participation is a problem they cannot directly address. A majority (83%) endorsed wanting to improve their consideration of barriers to REM participation as they design clinical trials and wanted help to improve (86%). Conclusion: Our results suggest there is awareness among clinical trial investigators at our academic center of disparities in REM participation in oncology clinical trials and the problem this poses to cancer care. There is also a pervasive view that primary barriers to REM participation are patient factors, and investigators do not feel they can directly address these. Nonetheless, there is motivation among investigators to improve in their ability to consider barriers to REM participation as they design clinical trials. Interventions that improve investigators’ self-efficacy for addressing barriers to REM participation in clinical trials, especially patient level barriers, are needed. Citation Format: Natalie P. Bransky, Anne M. Walling, John A. Glaspy, Maria Garcia-Jimenez. Exploring the unexplored: Clinical trial investigator perspectives of disparities in racial/ethnic minority participation in oncology clinical trials [abstract]. In: Proceedings of the 16th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2023 Sep 29-Oct 2;Orlando, FL. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2023;32(12 Suppl):Abstract nr A078.

Encouraging participation in cancer clinical trials, one step at a time.

Same-Day Consent for Regional Anesthesia Clinical Research Trials: It's About Time.

PurposeThis study explored perspectives on clinical trial-related financial considerations from patients with breast cancer receiving treatment in the Deep South who declined trial participation.MethodsThis qualitative content analysis included interview data from patients offered participation in a breast cancer clinical trial yet declined to participate from July 2020 to January 2024. Semi-structured interviews elucidated the influence of financial factors in the decision to decline enrollment onto a trial. Open coding was used to develop the codebook via an inductive approach to identify key concepts, patterns, and themes from the transcribed interviews. Transcribed interviews were then coded deductively by two independent reviewers.ResultsOf 21 patients with breast cancer, 43% and 57% previously declined participation in a therapeutic and non-therapeutic clinical trial. Interviews revealed four themes related to the influence of financial factors in the decision to decline participation in clinical trials, including (1) trial participation expenses (e.g., direct and indirect participation expenses), (2) insurance coverage (e.g., barriers for insured, resource for uninsured), (3) socioeconomic status (inequities and trust in clinical trials), and (4) financial compensation for trial participation (e.g., facilitating participation, inappropriate incentivizing).ConclusionFuture interventions targeting financial barriers to trial participation for patients most vulnerable to experiencing financial disparities are needed to diversify cancer clinical trial participation, thus ensuring results are generalizable to all patients.

620 Creating a culture of clinical research in the clinic: Integrating clinical trials into the care of patients with lupus

Racial and ethnic disparities in breast cancer clinical trial participation pose a significant barrier to providing equitable care. Black and Hispanic patients are underrepresented in clinical trials, and an improved understanding of barriers to enrollment is needed. To examine patterns of clinical trial discussion and participation and patient attitudes toward clinical trial participation in a diverse cohort of patients with breast cancer. This cross-sectional study used survey data from patients enrolled in the Chicago Multiethnic Epidemiologic Breast Cancer Cohort. Patients were queried about clinical trial discussion and subsequent enrollment in a therapeutic clinical trial. Barriers to trial enrollment were also assessed. Surveys were conducted from July to September 2022, and data were analyzed from February to October 2024. Self-reported race and ethnicity, including Asian, Black, Hispanic, and White. Outcomes of interest were discussing participation in a breast cancer clinical trial with a health care practitioner, participating in a clinical trial, and barriers to trial enrollment. Of 1150 respondents (mean [SD] age, 53.7 [11.9] years), 51 (4.4%) were Asian, 224 (19.5%) were Black, 35 (3.1%) were Hispanic, and 838 (73.0%) were White. A total of 447 respondents (38.9%) reported discussing trial participation with a health care practitioner. There were no differences in trial discussion between White patients and other racial groups (Asian: adjusted odds ratio [AOR], 0.75; 95% CI, 0.31-1.82; Black: AOR, 1.31; 95% CI, 0.78-2.21; Hispanic: AOR, 0.73; 95% CI, 0.26-2.08). Among 443 patients offered a trial, 285 (64.3%) participated. While there were differences in trial participation across racial and ethnic groups, these differences were not significant after adjusting for sociodemographic and clinical factors. Among 158 patients who did not enroll in the trial offered, 37 (23.4%) reported ineligibility, 17 (10.8%) were worried about the possibility of getting a placebo, 16 (10.1%) were worried about extra time required, and 14 (8.9%) were worried about possible adverse effects. This cross-sectional study demonstrated that when offered, patients across racial and ethnic groups were equally likely to participate in clinical trials. In addition to ineligibility, time toxicity was a significant barrier to enrollment. These data provide valuable insights that can serve as a roadmap for how to expand access to trials for all patients, regardless of racial, ethnic, and socioeconomic background.

Background: The rate of participation in clinical trials is dismally low, slowing the process of drug development and increasing cost. Patients living with metastatic breast cancer (MBC) are often willing to participate in clinical trials, but are frequently faced with insurmountable barriers. There is a dire need for studies identifying actionable patient-driven solutions to help ensure that opportunities to participate in clinical trials becomes more equitable, attractive and feasible for a larger, more diverse pool of potential participants. Methods: A mixed-methods design including in-depth interviews and online surveys was used to identify barriers and solutions to participation in clinical trials. Sixty-one participants were invited to be interviewed using purposeful stratified sampling (patient race, age and geographic location; community and academic center oncologists and administrators; researchers and research staff; payers). Interview questions were designed to collect feasible solutions to barriers. Convenience sampling was used to recruit MBC patient survey participants. Online surveys were fielded via nine MBC social media groups reaching approximately 1,500 patients living with MBC. Survey questions included demographics, trial experience, perception of benefits/disadvantages and barriers to trial participation, and ideas for solutions to the barriers. In addition, a short social media poll on trial participation was used. Results: A total of 496 women living with MBC completed the online survey. The mean age of survey respondents was 53 years old and mean number of years with MBC was 4.6 years. Respondents generally reported positive attitudes toward trial participation: The opportunity to get innovative treatments, helping others with MBC and contributing to research were rated as extremely important. Potential disadvantages included fear of side effects, possibility that trial drugs may not be effective and financial toxicity. Significant barriers included strict eligibility criteria, broad exclusion criteria and lack of trials nearby. All patients responding to a social media poll indicated they would consider participating in a clinical trial. Fifty-two participants were interviewed. The most frequent themes from patients were suggestions to address rigid eligibility and exclusion criteria by consistently including patients in research design, protocol development and policy decisions. Patients felt that trials should reflect the “real world”, and that opening up eligibility criteria would increase diversity and the number of potential participants. A dominant theme from rural and community-based oncologists was the need to address geographic, logistical and financial barriers using more “portable” multi-institution trials, providing transportation and adequate reimbursement for patients’ expenses. Clinicians in academic described exclusion criteria as a significant barrier for heavily pretreated MBC patients. Health care administrators discussed solutions to high costs associated with trials. Payers shared innovative solutions to out-of-network payment barriers. Conclusions: Most patients with MBC are willing to participate in clinical trials, and many are highly motivated to do so. MBC patients generally recognize the benefits that trials can offer and are willing and able to help address the barriers to trial participation by working collaboratively across the board. Multiple sectors of health-care are ready and willing to work together. It is in all our best interests to hasten the development of new treatments, and the time is right to implement a collaborative, systematic solutions-based approach that will make it feasible for more MBC patients to participate in clinical trials. This patient led study shows how this can be done. Citation Format: Marina Kaplan. Hear our voice: Patient-driven solutions to increase participation in clinical trials [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P1-16-03.

106 Background: People racialized as Black and/or African American (AA) represent less than 10% of participants enrolled in therapeutic cancer clinical trials that may improve cancer survival. AAs have higher cancer-related mortality rates but are less likely to be invited to participate in clinical trials compared to their white counterparts. We surveyed Black patients with cancer to assess their clinical trial discussion experiences and to identify opportunities to improve clinical trial participation. Methods: A purposive sample of 100 Black patients from a North Carolina Comprehensive Cancer Center were recruited to complete a survey between November 2021 and January 2023. Survey participants were identified through a clinical data warehouse and had to meet the following eligibility criteria: self-identified Black or AA race, diagnosis of either multiple myeloma, breast, prostate, colon, or lung cancer, and actively receiving or undergoing follow up cancer care. Surveys were conducted by a research assistant via phone. This analysis focused on those asked to participate in a clinical trial but declined participation. Results: All participants identified as Black or AA race with 2 participants additionally identifying as American Indian. Half of all surveyed participants were asked to participate in a clinical trial. Of those asked, 58% (n=29) declined and nearly half (n=12) indicated specific barriers that influenced their decision to not participate. Barriers included time constraints, distrust, fear of being harmed or being used as a guinea pig, not understanding the purpose of the study, and feeling rushed in their clinical trial decision making. All 29 participants were asked to select how they would prefer to receive clinical trial information and 97% selected speaking with their oncologist, 90% by video, 66% by internet and by a pamphlet or magazine, 52% at church and only 10% from a barber shop or salon. They also suggested simple and clear messaging about clinical trial opportunities, eligibility criteria, time commitment, taking time to discuss clinical trial options, and recruitment materials that can be taken home. Conclusions: Increasing participation in cancer clinical trials among Black patients with cancer necessitates careful discussion and consideration of fear, distrust, and system level barriers that influence the decision or capacity to enroll. Study recruitment should utilize patient centered communication tools that acknowledge the history of research exploitation in Black communities and clearly describe safety and security measures used in clinical trials.

198 Background: We reported in 2011 at the Society of Surgical Oncology a 19 year retrospective at a single academic institution which identified practice differences between surgical oncologists and general surgeons which were associated with a significant survival advantage. Clinical trial participation was much higher amongst patients treated by a surgical oncologist. Methods: This is an IRB approved, retrospective review of all breast cancer patients receiving primary treatment at a single institution from 1/1/2001 to 12/31/2008. Details of pathology, surgical therapy, chemotherapy, hormonal therapy and radiation therapy were compared between patients participating in clinical trials and those not participating. The specific trials were segregated as to type (tissue banking, therapeutic, prevention, etc.) to understand differential effects if any between type of trial participation. Results: During the time period, there were 1220 patients who received primary breast cancer treatment at this institution. The mean age was 55.6 and mean follow-up >40 months. Stage distribution was stage 0 - 16.8%, Stage 1 - 26.6%, Stage 2 - 33.1%, Stage 3 - 15.9%, and Stage 4 - 6.1%. Patients participating in any clinical trial numbered 468 and 752 participated in no clinical trials. Overall survival (clinical trial 98.8% vs. not in clinical trial 75.7%; p<0.0001). Overall the use of breast conservation was more likely in clinical trial participants (54.3% vs. 44.4%; p<0.0001). The completion of chemotherapy was more likely in clinical trial participants (52.4% vs. 49.5%; p=0.02).The successful completion of systemic therapies (chemo and hormonal) was more likely also (71.4% vs. 64.0%; p=0.009). The type of trial (tissue banking vs. therapeutic) had no effect on improved outcomes. Overall the best predictor of better outcomes was to be treated by a high volume clinical trial enrolling physician. Conclusions: High volume clinical trial enrollment is associated with the best overall treatment outcomes in breast cancer whether trials are directly related to therapeutic changes or not. Each individual in the breast center treating team can have dramatic effect on outcomes by improving their clinical trial enrollment and participation.

108 Background: Thirty years after the NIH Revitalization Act, racial/ethnic minority (REM) patients remain underrepresented in oncology clinical trials. Little is known about clinical trial investigator perspectives of REM participation in clinical trials. To our knowledge no published studies exist assessing differences in investigator perspectives based on their primary role in the clinical trial process. We hypothesized that differences exist in investigator perspectives regarding REM participation in oncology clinical trials based on having a more design-oriented (principal (PI)/co-investigator (co-I)) or recruitment-oriented role (sub-investigator (sub-I)). Methods: We conducted a cross-sectional, anonymous, pilot survey of oncology clinical trial investigators at an academic center. Over 5 weeks, 107 individuals received a survey assessing 6 domains about disparities in REM participation in clinical trials, including knowledge, attitudes, and prior training. Modified, previously validated items were used if possible. We performed a subset analysis of mid- and late-career investigators (>/= 10 years of experience) comparing those who opened at least 1 clinical trial in the past year as PI or co-I to those who did not (sub-I). Results: There were 60 respondents (56% response rate). Average time as a clinical trialist was 14 years (2-40). Average number of trials opened in the last year as PI/co-I was 4 (1-30). Among all respondents, 83% strongly agreed disparities exist in REM clinical trial participation and that lack of diversity is problematic (75%). Notably, 45% agreed this is a problem they cannot directly address. Among mid- and late-career investigators, those who opened at least 1 trial as PI/co-I were more likely to have received training about barriers/facilitators (OR=3.56; 95% CI=1.05, 12.04; p=.04) to REM clinical trial participation and about strategies for improving participation (OR=3.75; 95% CI=1.06, 13.29; p=.04). Despite this, they were more likely to endorse wanting help to improve in this area (OR=4.95; 95% CI=1.17, 21.02; p=.03). Conclusions: Our results suggest there is awareness among clinical trial investigators of disparities in REM clinical trial participation, but investigators do not feel they can directly address these. Investigators who are more involved in clinical trial design are more likely to want help to improve their ability to address disparities in REM trial participation despite being more likely to have received prior training on the topic. Our findings suggest training alone is inadequate support for investigators involved in designing clinical trials. More studies eliciting the needs of investigators with varying roles in the clinical trial process are needed to inform targeted interventions to enhance investigators’ self-efficacy for improving REM participation in clinical trials.