Whose Autonomy Matters? Using Relational Autonomy to Analyze Caregiver Roles in Decision-Making for Cancer Clinical Trials

Mitigating Administrative Risks in Industry-sponsored Clinical Trials

Diversity and Inclusion in Pancreatic Cancer Clinical Trials

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

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

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

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?

The mediating effect of shared decision-making in enhancing patient satisfaction with participation in cancer clinical trials

"If You Don't Trust Your Doctor That Much...You'd Feel Less Confident Doing a Research Study": Factors Influencing Black Patient Participation in Hematology Trials

AIDS clinical trials. Is there access for all?

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.

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.

This article discusses the barriers that prevent deaf people from participating in clinical trials and offers recommendations to overcome these barriers and ensure equal access to study participation. Between April and May 2022, we conducted six focus groups with 20 deaf adults who use American Sign Language, all of whom had previous experience as research study participants. Focus group prompts queried community awareness of clinical trial opportunities, barriers and facilitators to deaf people's participation in clinical trials, and recommended resources to improve clinical trial access. This qualitative focus group data is supplemented by survey data gathered from 40 principal investigators and clinical research coordinators between November 2021 and December 2021. The survey queried researchers' prior experiences with enrolling deaf participants in clinical trials and strategies they endorse for enrollment of deaf participants in future clinical trials. Focus group participants unanimously agreed that, compared to the general hearing population, deaf sign language users lack equivalent access to clinical trial participation. Reported barriers included lack of awareness of clinical trial opportunities, mistrust of hearing researchers, and refusal by clinical trial staff to provide accessible communication (e.g. denial of requests for sign language interpreters). Survey data from 40 principal investigators and clinical research coordinators corroborated these barriers. For example, only 2 out of 40 survey respondents had ever enrolled a deaf person in a clinical trial. Respondents indicated that the most helpful strategies for including deaf sign language users in future clinical trials would be assistance with making recruitment information accessible to deaf sign language users and assistance in identifying qualified interpreters to hire to help facilitate the informed consent process. The lack of communication accessibility is the most common factor preventing deaf sign language users from participating in clinical trials. This article provides recommendations for hearing researchers to improve deaf people's access to clinical trials moving forward, drawing from mixed-methods data.

Key Barriers to Clinical Trial Enrolment: A Survey of Clinical Trial Staff at an NCI Designated Cancer Center

The Native Hawaiian population of Hawaii has disproportionately high cancer incidence and mortality rates. Native Hawaiian women with breast cancer present at an advanced stage and have death rates that are 52 % above the state average. Prostate cancer among Native Hawaiian men is diagnosed at more advanced stage. Native Hawaiian participation in cancer clinical trials was historically low. Reasons for this were varied including access, health literacy, lack of primary and referring physician awareness/time constraints and cultural barriers. Since the establishment of the University of Hawaii Minority Based Clinical Oncology Program (UHMBCCOP) participation in cancer clinical trials has definitely increased. MBCCOP provided clinical trial promotion, increased access and clinical trial support for a group of hospital and office based oncologists across the islands of Oahu and Kauai have all contributed to the increase. Education programs in Hawaii by multiple organizations, in particular, Imi Hale, the Native Hawaiian Cancer Network Program have enhanced knowledge of cancer and clinical trials in the Native Hawaiian community. Imi Hale's emphasis has focused on community based patient training, patient navigation and referring physician cancer clinical trial training. In fact, a recent program was recently initiated in conjunction with Education Network to Advance Clinical Trials (ENNACT) and Queens Medical Center. Review of Native Hawaiian participation in both cancer prevention and treatment trials through the UHMBCCOP over the last 20 years shows a significant gender difference with more women participating in both prevention and treatment trials. The reasons for this are not well understood but are under investigation. In summary, increased focused access and community based education have improved Native Hawaiian participation in cancer clinical trials but challenges persist including gender disparities in enrollment onto clinical trials and lack of access outside of Oahu and Kauai islands. Citation Format: Jeffrey L. Berenberg. Overcoming cultural and geographic barriers to participation in clinical trials among Native Hawaiians. [abstract]. In: Proceedings of the Sixth AACR Conference: The Science of Cancer Health Disparities; Dec 6–9, 2013; Atlanta, GA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2014;23(11 Suppl):Abstract nr PL02-03. doi:10.1158/1538-7755.DISP13-PL02-03