June 12, 2023
Irby Hunter, Jr., MD Medical Director Oncology Independent Medical Education Inc & Executive Publisher Oncology Disparities Peer Reviewed Scientific Journal
Thought leaders participating in the 59th Annual Meeting of the American Society of Clinical Oncology (ASCO) revealed new evidence about cancer disparities and offered several innovative solutions.
Cancer affects all population groups in the United States, but due to social, environmental, and economic disadvantages, certain groups bear a disproportionate burden of cancer compared with other groups. Cancer disparities are differences in cancer measures such as: incidence, prevalence, mortality, survival, morbidity, survivorship, financial burden, screening rates and stage at diagnosis. Population groups that may experience cancer disparities include groups defined by race/ethnicity, disability, gender, identity, geographic location, income, education, age, sexual orientation, national origin, and other characteristics. Among the recent advancements in cancer disparities, one presentation at the 59th Annual Meeting of the American Society of Clinical Oncology (ASCO) highlighted equitable access to clinical trials.
The Future of Equitable Access to Clinical Trials session was chaired by Steven Gore, MD, of the National Cancer Institute (NCI). Lola A. Fashoyin-Aje, MD, MPH, U.S. Food and Drug Administration (FDA) and Ana Acuna-Villaorduna, MD, Montefiore Medical Center Albert Einstein College of Medicine served as symposium faculty. This august collection of thought leaders provided evidence of inequities, discussed barriers against inclusion, and shared innovation for expanding diversity.
The symposium commenced with the faculty sharing their concerns about the mismatch between the patients participating in clinical trials and the patients whom are being treated clinically. It is important to note that this disparity is not a moral issue it is a scientific issue, because there are two factors affected by disparities in clinical trials: generalizability of clinical trial results and efficiency of care delivery. As a result of this inequity, excluded populations are granted limited access to potentially efficacious investigational therapy. Furthermore, clinicians and pharmacists lose the opportunity to understand drug pharmacodynamics and pharmacokinetics in these individuals. Education symposium chair, Dr. Gore, confirmed that academic cancer centers have yet to address this disparity adequately.
Historically, race and ethnicity has been under reported in clinical trials. Loree et al. studied 230 clinical trials from two different time periods (2008-2013 and 2013-2018). Whites were the most commonly reported race in both time periods. Blacks and Hispanics were significantly under reported. For example, Blacks were reported in 33% during the years of 2008 to 2013 and 40% between 2013 and 2018. Even more alarming, Loree et al. identified that Hispanics were reported to be as low as 7% for the second time period. Additionally, Duma et al. reported non- Hispanic Whites were more likely to participate in clinical trials than non- Hispanic Blacks and Hispanics. Duma reported a 14- year steady decline in the number of non-Hispanic Blacks being recruited onto clinical trials. Fashoyin-Aje et al. studied the racial composition of participants enrolled in oncology clinical trials in the US, as well. The research group examined over 6,000 clinical trials over a seven- year period. Results revealed White individuals significantly out- weighed the number of Asian, Hispanic and non- Hispanic Black participants in US oncology clinical trials.
Symposium faculty members discussed the many barriers preventing ethnic minorities from going onto clinical trials. Institutional barriers include deficient screening, poor trial matching, gaps in trial portfolios, prolonged activation times, and no periodic self-assessments. Barriers at the provider level include implicit bias, lack of awareness, and lack of workforce representation. Restrictive eligibility criteria continue to be a common barrier associated with study design. Patient distrust, financial status, poor access, limited social support and logistic issues may all present challenges for individuals seeking to go onto clinical trial.
Potentiating solutions were a hot topic for symposium faculty. Just Ask is a publicly available training program designed to help researchers identify and address implicit bias. The Robert A Winn Diversity in Clinical Trials Program, is training program geared toward supporting career development of early-stage investigators who are committed to increasing inclusion in clinical trials. Project Equity, an FDA Oncology Center of Excellence Initiative, aims to ensure the clinical trial population is representative of the population with the disease or condition. Outreach and engagement, policy development, and research are the main components of the program, as well. The initiative prompts sponsor to consider several important factors: 1) the necessity for a medical product to be developed in a study population that reflects the diversity of the population for which the medical product is intended, 2) drug effects in context of diverse populations, 3) generalizability of study results to the population affected by the disease, and 4) the need to generate evidence that is applicable to the US population as a whole.
FDA’s most recent policy initiative, Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trial Guidance for Industry, provides a framework for sponsors to learn about the FDA’s expectation for inclusion. There are four elements of the FDA Diversity Plan: disease overview, scope of clinical development, enrollment goals, and actions to enroll and retain participants. In support of diversity, these four elements ignite sponsors to initiate the following strategies:
- provide an overview of the disease including prevalence and distribution across relevant demographic subgroups,
- provide an overview of the disease including prevalence and distribution across relevant demographic subgroups,
- provide an overview of the disease including prevalence and distribution across relevant demographic subgroups,
- establish specific enrollments goals, and
- share the planned tactics for achieving the enrollment goals.
Secondarily, FDA Diversity Plans are designed to achieve the following objectives:
- Establish and sustain partnerships with relevant communities, patient advocacy, and community practices,
- Assess patient characteristics, treatment landscapes and outcomes, and specific enrollment goals,
- Assess patient characteristics, treatment landscapes and outcomes, and specific enrollment goals,
- Initiate operational strategy early in clinical development to plan for diversity,
- Revise study assumptions based on accumulated data/information,
- Develop and implement real-time measures to monitor study accrual relative to specified goals, and
- Develop infrastructure with capability to conduct clinical trials.
Dr. Gore elaborated on NCI’s CATCH-UP Program. Create Access to Targeted Cancer Therapy for Undeserved Populations (CATCH-UP 2020), a congressionally funded pilot project designed to increase recruitment of underserved individuals across several clinical trial sites in the United States. CATCH-UP 2020 is comprised of eight NCI designated cancer centers. These eight centers have proven track record in accruing minority/underserved populations to NCIs Experimental Therapeutics Clinical Trials Network (ETCTN). CATCH-UP 2020 cancer centers are required to accrue a minimum of 24 patients annually NCI clinical trials. Ongoing funded mandates that at least 50% of the recruited patient belong to a minority/underserved population. The program organizers drafted multiple secondary objectives:
- Learn and share best practices for outreach to underserved communities
- Learn and share best practices for coordination with distant outlying sites
- Learn and shared best practices for integration of telemedicine and other technology for precision medicine, and
- Set standards for comprehensive cancer center outreach
In 2022, CATCH-UP initiative institutions were collectively successfully increasing the number of underserved individuals being recruited onto precision medicine clinical trials from 13% to 23%; these institutions shared best practices for recruitment. Patient navigators assisted patients in maneuvering through the health care system. Many institutions immersed themselves into the community fostering trust among individuals. Telemedicine was utilized to recruit patients across a broad geographic area. Many investigators were persistent in their diligence. Cancer Center Community Outreach offices were opened. Investigators were encouraged to focus on Phase 2 versus Phase 1 trials.
Baranada et al. recently validated the utility of the CATCH-UP initiative. The research group reported from September 2020 to August 2021, CATCH-UP.2020 sites opened 45 ETCTN trials. In the programs, initial year, the sites enrolled 145 patients in CATCH-UP.2020 with 46.9% of the enrollees representing racial, ethnic, rural, and socioeconomically underserved populations. The study’s results clearly reveal that targeted funding and accelerated accrual practices expand access to early phase trials among underserved populations.
Oncology Independent Education (OIE) certainly applauds the effectiveness FDA’s Diversity Plan. OIE is interested in participating in future discussion around specified recruitment goals for sponsors. OIE supports targeted funding programs such as CATCH-UP. However, OIE recommends fixed funding for smaller communities and rural based cancer centers. Implicit bias has to be addressed system wide. Financial and travel barriers should be accounted for by study design. Stay tuned to www.oncodisparities for current and impactful information about oncology disparities.
References
- Fashoyin-Aje, Lola., Acuna-Villaorduna, Ana., Gore, Steven. 2023, June 4. The Future of Equitable Access to Clinical Trials. [Education Symposium]. 2024 American Society of Clinical Oncology ASCO Annual Meeting. Chicago, Illinois. www.asco.org
- Baranada, Joaquina, et all. 2022. Expanding access to early phase trials: the CATCH-UP.2020 experience. December 16, 202. Cancer Spectrum. Retrieved from www.cancerspectrum.com on June 3, 2023.
