The ultimate goal of health care innovation is to improve health outcomes and population health, but systemic, structural, and clinical barriers prevent valuable innovation from reaching all patients efficiently and equitably. For example, biomedical breakthroughs are not always “user-designed,” resulting in outputs that do not necessarily reflect patients’ needs, incorporate their preferences, or consider accessibility or affordability. Innovation is fruitless if it doesn’t reach the patients who need it. Clinical research, which forms the foundation for understanding and developing treatments for conditions such as cancer, can only realize its full potential when these multi-level barriers to innovation and its spread are eradicated.
Cancer clinical trials are a key step in advancing novel treatments from the research setting to direct patient care. Data shows that clinical trial participation is correlated with longer survival and lower mortality. The opportunity to participate in a clinical trial is considered high-quality cancer care, but access to and participation in these trials remains inequitable. Underrepresentation of racial and ethnic minoritized groups, low-income individuals, those who live in rural areas, people aged 70 and older, and adolescents and young adults in cancer clinical trials limits the quality of the science and prevents some patients from accessing the highest standard of care. Distrust in the medical community is further compounded when patients do not see themselves represented in research. As a result, these groups have not benefited equitably from medical advances and continue to be vulnerable to health disparities. This inequity is a matter of social justice.
Improving Diversity in Clinical Trial Participation: Federal Priorities and Opportunities
Increasing representation in clinical trials, which improves the validity and generalizability of resulting treatments, is now a major policy priority for the federal government. One example is the 2022 Diverse and Equitable Participation in Clinical Trials (DEPICT) Act. This legislation aims to increase diversity in clinical trials by requiring sponsors to report data on participant demographics and provide resources to underrepresented communities to improve access to and participation in clinical trials. As part of the DEPICT Act, the FDA requires clinical trial sponsors to submit Diversity Action Plans that detail the actions the sponsor will take to reach their enrollment targets. Additionally, in June 2024, Rep. Diana DeGette (D-CO) and Rep. Larry Bucshon, MD (R-IN) issued a request for information to seek input from stakeholders on approaches needed to improve the effectiveness of the 21st Century Cures Act and Cures 2.0 Act goals. These recent legislations affirm increased diversity and access to clinical trials, expanded patient access to telehealth, and increased funding for research institutions.
Various federal agencies have also undertaken measures to improve clinical trial accrual for underrepresented groups. The White House Office of Science and Technology Policy (OSTP) is leading a whole-of-government approach to strengthen clinical trial capacity in the nation. The Clinical Trials Readiness initiative aims to build a stronger, diverse, inclusive, and more efficient clinical trial infrastructure to accelerate the development of treatments for cancer and drive forward the goals of the Cancer Moonshot initiative. Additionally, the National Institute of Health has developed guidelines to ensure the inclusion of women and other underrepresented groups across the lifespan, in clinical research as part of its Minority Health and Health Disparities (NIHMD) 2021-2025 strategic plan. Similarly, the US Department of Human and Health Services’ (HHS) 2023 Equity Action Plan commits HHS to continuing their efforts to increase the diversity of research and clinical trials to inform that science.
Increasing Clinical Trial Accrual Through An Equity in Access Grant
The lack of representation among diverse patient groups in cancer clinical trials requires urgent attention and rectification. While many studies have documented the multilevel barriers that prevent equitable access, few have rigorously tested interventions to improve accrual, and most focus on patient-level barriers rather than the root causes at the system-, institution-, and provider-level. Complementing federal efforts and initiatives, The Leukemia & Lymphoma Society (LLS) is committed to promoting access and increasing accrual in therapeutic cancer clinical trials for patients from underrepresented groups.
As part of their Equity in Access Research Program and based on a scoping review, LLS recently launched a new Request for Proposals (RFP). They are currently accepting applications for up to $2.5 million in funding to implement and evaluate interventions a) to mitigate multilevel barriers to therapeutic clinical trial accrual for underrepresented groups and b) to quantitatively measure the impact of these interventions on patient accrual. Funded studies will guide changes in health care policy and practice to ensure that all patients have the ability to access and utilize optimal treatment and care that can improve their quality of life and outcomes. The funding opportunity is open to researchers in all stages of their careers. Proposed interventions should include blood cancer therapeutic trials, but therapeutic trials may also be included for other cancers. The Principal Investigator and other study team members may come from a variety of disciplines, and multidisciplinary teams are highly encouraged to apply. LLS looks forward to seeing the contributions of researchers to bolster understanding of effective interventions for increasing accrual to cancer clinical trials, particularly among underrepresented populations! Letters of intent are due September 12, 2024, by 3pm ET.
For the Community, with the Community, by the Community
Promoting access and enhancing participation in clinical trials requires established trust, especially when engaging with racial and ethnic minoritized groups who may lack trust in the health care and research system due to historical injustices. Patient advocacy groups, community organizations, and navigators are well-suited to lead these efforts due to the established, trusted relationships they have with patients. While stakeholders are making significant investments to address access, awareness, and trust issues related to participation in clinical trials, there is consensus within the industry to meet the patients where they are. However, no single organization can do this alone. Overcoming barriers to clinical trial accrual, particularly among underrepresented populations requires cross-sector commitment and collaboration. Bridging the gap between health care innovation, clinical research, and true patient access is essential for improving clinical trial participation and infrastructure, which can ultimately advance health equity and improve patients’ quality of life and outcomes, from diagnosis through survivorship.