Participatory Action for Access to Clinical Trials (PAACT): Increasing participation of blacks in Southeastern Michigan in cancer clinical trails.

Abstract

e18527 Background: The underrepresentation of minority populations in research violates principles of distributive justice, slows scientific progress, and exacerbates health disparities. Henry Ford Cancer Institute (HFCI) is one of 20 sites offering clinical trials in Michigan and currently participates in 1300 trials. The rate of cancer cases at HFCI is 78% in whites and 21.9% in Blacks/African Americans (B/AA). However, analysis of cancer clinical trials conducted at HFCI showed participation rates to be 2.66% in B/AA and 90.28% in whites. Diverse attempts by HFCI to improve participation of B/AA in clinical trials have yielded limited success. The Participatory Action for Access to Clinical Trials (PAACT) project is using a community-based participatory research (CBPR) approach to design/adapt, pilot, and evaluate interventions which address cancer clinical trial participation barriers among B/AA. Methods: PAACT uses a 5-step approach: 1. Establish a steering committee (SC) in partnership with the Detroit Urban Research Center, which has a strong history of implementing CBPR programs in Detroit. 2. Conduct a scoping review to evaluate evidence-based strategies and interventions used to engage B/AA communities in clinical trials. 3. Conduct qualitative and quantitative research with members of B/AA community, cancer survivors/patients, and HFCI providers. 4. Engage stakeholders in the interpretation and translation of data to inform intervention strategies. 5. Pilot the intervention(s) to assess B/AA individuals’ behavioral intentions to enroll and participate in cancer clinical trials, and health care providers’ intentions to engage in change processes. Results: We have conducted 13 SC meetings, co-facilitated by a community, academic and health system partner. The SC has been actively engaged in all aspects of the project. Through the scoping review, we identified five categories of recruitment and retention strategies. We have conducted 13 focus groups with 100 participants, 7 provider interviews, and administered 1 survey to HFCI staff. Data from the focus groups has provided information on respondents’ clinical trial knowledge and systemic, socio-cultural, and economic barriers to trial participation. Data from the provider interviews has provided information on experience with clinical trial recruitment and recommendations for improving participation among B/AA community members. Conclusions: Through CBPR, PAACT actively engages B/AA community members, survivors/patients, healthcare providers, and researchers in the process to develop/adapt, implement, and evaluate strategies to better inform communities and patients about cancer clinical trials. The long-term goal of this project is to implement changes in both the community and the health care system thereby increase levels of participation in clinical trials among B/AA.

Understanding the inclusion and participation of adults from Black African Diaspora Communities (BAFDC) in health and care research in the UK: a realist review protocol

“…Exclusion has been related to the lack of reporting of outcomes in research studies by race and ethnicity, impacting on the evidence base for clinical decision-making 14. Exclusion is reported to have been observed in commercial cancer trials, where eligibility criteria can be very restrictive 50–52. These trials often exclude individuals with comorbidities, which are more prevalent in black and ethnic minority populations, preventing access to new treatments, such as immunotherapy 51 52.…”

“…Exclusion is reported to have been observed in commercial cancer trials, where eligibility criteria can be very restrictive 50–52. These trials often exclude individuals with comorbidities, which are more prevalent in black and ethnic minority populations, preventing access to new treatments, such as immunotherapy 51 52. The impact of eligibility criteria on inclusion requires further investigation to find solutions.…”