By Manmeet Ahluwalia, M.D., M.B.A., Miami Cancer Institute, part of Baptist Health South Florida
Ethnicity, age, and sex can all impact safety and efficacy of any medication in people. Hence, diversity among clinical trial participants is critically important, as diverse groups of clinical trial participants provide us with better information on the effects of the drug in different patient populations. It is important that clinical trial enrollment represents the real-world population that will use the drug once it is FDA approved.
However, detailed drug approval data from the FDA’s 2018 Drug Trials Snapshots demonstrated the existential challenge in disparities — over 5,000 cancer patients participated in trials that resulted in 17 new drug approvals. Overall, 68% were White, 15% were Asian, only 4% were Black or African American, and another 4% were Hispanic. These proportions were in stark contrast with the racial distribution in the United States population (76.6% White, 13.4% Black or African American, 5.8% Asian, 18.1% Hispanic or Latino [yes, this adds up to 113.9%; people can identify as more than one race]). This gap, unless addressed, will become even more stark due to changing demographics, as more than 50 percent of the U.S. population is predicted to Hispanic, Asian, and African American by 2050. This makes lack of diversity in clinical trials a moral, scientific, and public health crisis. There is an urgent need to develop a strategic Actionable Framework to Address Cancer Care Disparities and enhance the enrollment of minorities in clinical trials.
The FDA recognizes the significance of increasing the diversity, as signaled by the issuance of draft guidance in 2020 – Enhancing the Diversity of Clinical Trial Populations – Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry. This document marks a major step toward increasing the representation of historically underrepresented populations in clinical trials by overcoming barriers they face.
Considering the public health and social equity perspective of the population, we have to understand the fact that each minority group has its own diverse needs and challenges. Health policies that are diversity focused are the need of the hour. We must diversify the workforce for clinical trial recruitment to ensure health equity and better cancer outcomes.
Traditionally underserved populations have unique challenges in access and type of healthcare available, the ratio of patient population insured, and access to tertiary healthcare for diagnosis and management. These multifactorial causes do influence their patient outcomes and screening results. Health inequities are related to the health insurance demographics, low or lack of preventive services, accessibility to nutritious foods, etc.
Specific interventions to ensure participation of underserved groups to enhance diverse clinical recruitment include:
- Look into understanding barriers unique to each minority population and formulate a proper health policy plan to overcome each barrier. Diverse enrollment should be a major mandate for both the National Cancer Institute as well as the FDA; in addition, major professional societies should institute measures to further enhance the participation of minorities in clinical trials.
- Understand the critical role of social determinants of health and how they affect minorities’ participation in trials. Effective strategies must be developed to mitigate the socioeconomic disparities that tend to more greatly affect minority populations.
- Create health literacy and awareness campaigns with the help of local organizations and community leaders to encourage diverse participation in cancer screenings. Cancer screening in minorities is lower than the national benchmark. The following are some of the ways local organizations can help increase the health literacy of minority populations:
- Visual aids detailing the screening and other services available at a cancer center can be used by the local organizations like churches and community groups.
- Create online and in-person social support groups for cancer patients.
- Carnivals, fairs, and local events can be used for screening and enrollment purposes.
- Local radio stations can advertise about cancer awareness events in the area.
- Expand the eligibility criteria in clinical trials in order to increase the minority enrollment. It is well documented that minorities suffer from comorbid conditions more than the Caucasian population. Hence, less restrictive eligibility criteria will improve the participation and involvement of minorities in the clinical trials process. Clinical trial minority recruitment should start at the early phases of trial design, meaning Phase 1 of clinical trial and not at registration-level study. This will help identify early efficacy or toxicity signals. More representation means better prediction of disease outcomes and better treatment options on the public health continuum.
- Connect with faith-based organizations (FBOs), as they play a critical role in helping shape the mindset of minorities. In clinical trials, lack of trust has been a major issue. Community- and faith-based organizations can go long way to establish the necessary trust. The intersection of FBOs and early preventive health services, including health education regarding recruitment for clinical research trials and studies, is long-standing. Churches and other FBOs are the focal point of community aggregation and can be used for health education or informing attendees about available health programs.
- Create a community needs assessment and patient-friendly navigation system suited to local patient needs. This can be done by hiring multilingual and culturally sensitive patient navigators and enlisting the support of local patient advocacy groups. As clinical trials are focused on patient needs, having patient navigation tools at sites, such as apps or individual patient navigators that are proficient in the local languages and dialects, can promote better understanding of the trial in easy and relatable ways that will help augment trial participation.
- Increase clinical trial participation in cities that have more diverse patient populations, as well as in rural areas. Most trials have taken place in academic hubs like Boston, yet minority patients may reside in more culturally diverse cities such as Miami, which is more likely to have a Hispanic population from Latin America, whereas Los Angeles may have more Hispanics of Mexican descent.
- Overcome linguistic barriers by using language-specific consent forms and live translation, either digitally or by multilingual personnel. For studies with a Hispanic patient population, consent forms in Spanish are useful to explain the document to the patients and caretakers. This can alleviate anxiety and worry about the process of enrollment. This also helps to create buy-in from minorities and builds trust.
- Recognize that there are racial differences in the genetic makeup of cancers in minorities. Biomarker-based cancer therapies and precision oncology are an important part of choosing the most effective treatment options for every patient. This premise of precision oncology will not reach its maximum benefit as long as racial disparities persist. Dedicating our efforts to advancing genomic profiling and clinical trials will further our understanding and care of our minority patients.
- Increase the use of telemedicine technologies to expand trials to underrepresented areas. The obstacles of distance, cost, and availability tend to affect minority patient populations much more than Caucasians. Patient-centered technology to implement virtual clinical trials will reduce the struggles of cost and distance, which act as barriers for communities of color. Remote support and digital health technologies should aid in better recruitment practices, such as, for example, in electronic consenting.
These interventions, along with others, will help facilitate minority enrollment in clinical trials. With a more representative patient population, trials will have outcomes that are more accurate in real-world cancer patients. In addition, racial and ethnic minority groups will benefit from this increased access to novel drugs in clinical trials, rather than waiting for drugs to be FDA approved without adequate knowledge of efficacy and toxicity, as toxicity and efficacy differ across races and ethnicities.
About The Author:
Neuro-oncologist and medical oncologist Manmeet Ahluwalia, M.D., M.B.A., is deputy director, chief scientific officer, and chief of solid tumor medical oncology at Miami Cancer Institute, a part of Baptist Health South Florida. Board certified in internal medicine, medical oncology, neuro-oncology, and hematology, Dr. Ahluwalia is a leading expert in brain metastases and primary brain tumors. Dr. Ahluwalia’s research focuses on developing new therapies for patients with brain tumors and brain metastases. He is an internationally recognized clinical investigator with deep ties in both the established and start-up pharmaceutical communities, both of which have led to his role as principal investigator on many multi-site national and international studies involving many solid tumor types.