Imagine a world with equitable healthcare research tailored to meet the needs of every individual. A world where diverse patient populations are actively included in clinical trials, ensuring that medical advancements benefit everyone equally. This vision of healthcare equity is desirable and essential for addressing health disparities and improving outcomes for all.

However, the underrepresentation of diverse patient populations in clinical trials remains a challenge, urging us to seek innovative solutions for diversity in clinical trials.

Including diverse patient populations in clinical trials is crucial for healthcare equity and improved outcomes. These populations encompass genetic, environmental, and socio-cultural factors influencing disease presentation, treatment response, and adverse effects. Diversity within clinical trials ensures that findings are more representative of real-world patient populations, leading to improved generalizability and applicability of research outcomes. For instance, a study examining the efficacy of a cardiovascular medication may yield different results when tested on a homogenous population versus a diverse one, highlighting the importance of inclusivity in clinical trials for accurate and relevant findings across all patient groups.[1] Additionally, involving the underrepresented patient populations in clinical research allows for identifying disparities, factors contributing to inequalities, and the development of targeted interventions to address specific health needs and improve healthcare outcomes. For example, in diabetes management trials, including individuals from underrepresented communities can shed light on the unique challenges they face, such as barriers to medication adherence or culturally appropriate dietary interventions.[2] This knowledge can inform the development of tailored strategies to improve diabetes care in these populations.

Access and participation in clinical trials for underrepresented patient populations face various barriers. Language and communication pose significant challenges as patients not proficient in English, struggle to access, and comprehend crucial information. Limited translation services delay informed consent forms and trial materials exacerbating this barrier. Additionally, mistrust in the medical system and research institutions poses a significant challenge. Historical injustices, unethical research events, and the underrepresentation of diverse populations have fueled skepticism and reluctance to participate. Rebuilding trust requires transparent communication, addressing fear and stigma, and engaging communities to foster a supportive environment for potential participants. Furthermore, access barriers, including limited trial availability in underserved areas and stringent eligibility criteria, impede participation. Financial constraints, such as transportation costs, childcare, time away from work, and limited insurance coverage, also present significant challenges.[3][4][5] Overcoming these barriers requires targeted interventions, such as providing multilingual trial materials and interpretation services, engaging with community leaders to build trust, expanding the geographic reach of trials, advocating for more inclusive eligibility criteria, and offering financial assistance for trial-related expenses.

On Jun 18, 2013, the Pharmaceutical Research and Manufacturers of America, the National Minority Quality Forum, and Microsoft joined forces to improve care for people with type 2 diabetes mellitus and cardiovascular diseases and supported the creation of the National Clinical Trial Network (NCTN), an interactive portal designed to connect patients, physicians, and researchers, facilitating diverse trial participation. The NCTN would serve as a permanent IT infrastructure where investigators could quickly identify minority populations who share a medical need and efficiently recruit them for appropriate trials.[6] Currently, the platform consists of various clinical trial groups that focus on different types and treatment of cancer.

As a former member of a patient retention panel achieving a remarkable 98% retention rate over a 6-year trial, establishing a recruitment panel will likely increase recruitment rates. Establishing a recruitment panel per each clinical trial comprising investigators, clinical trial coordinators, sponsors, and expert representatives from each underrepresented population offers significant advantages in improving access and participation for underrepresented patient populations. The panel can use their collective expertise to enhance trial design, develop targeted recruitment strategies, and foster comprehensive participant engagement. Investigators bring clinical knowledge and research experience to design trials accommodating underrepresented communities’ specific needs and concerns. Coordinators provide insights into logistics and streamline trial processes for improved patient experiences. Community outreach specialists collaborate with local organizations, conduct educational workshops, and actively engage with underrepresented communities to build trust and awareness about clinical trials. Patient advocates contribute perspectives and guidance on creating patient-centered approaches considering cultural, social, and logistical factors. Involving representatives of underrepresented patient populations integrates diverse perspectives into the decision-making processes of clinical trials. It provides valuable insights into cultural sensitivities, health beliefs, and their communities’ challenges, informing trial design and implementation. By working together, the recruitment panel gathers insights, co-creates strategies, and develops patient-friendly materials and communication channels that address the unique challenges faced by underrepresented communities.

ClinicalTrials.gov, a comprehensive database, gets about 4.5 million visitors monthly and currently lists 460,207 studies.[7] Developing a patient-friendly platform linked to ClinicalTrials.gov with the help of the recruitment panel of each trial is crucial in providing easily accessible, understandable, and culturally sensitive information about clinical trials to patient populations. Translating and presenting the same information from ClinicalTrials.gov in a patient-friendly language. This platform aims to ensure that details of each trial, including purpose, eligibility criteria and potential benefits and risks, are communicated easily. The platform’s key features include simplified language, a user-friendly interface, and interactive communication capabilities. Patients can create profiles, search for studies, and submit questions regarding eligibility criteria, time commitments, and potential side effects, receiving timely responses from research staff.

Additionally, a research site search based on zip code eliminates distance barriers. Educational resources are also available to enhance patients’ understanding of clinical trials and their rights and responsibilities as participants. The patient-friendly platform combines information from ClinicalTrials.gov with the efforts of the recruitment panel, promoting patient engagement, trust, and meaningful participation while ensuring equitable access to clinical trials for underrepresented patient populations.

In collaborative efforts with the recruitment panel and creating a single patient-friendly platform linked to ClinicalTrials.gov, we can envision a future where healthcare research benefits every individual. Throughout history, there have been good ideas to address barriers and bring diversity to clinical trials, but they have been scattered. It is time to come together and achieve a unified solution. Together, we can build a world where no one is left behind in the pursuit of better healthcare.

REFERENCES

1. Kalra, D. K. (2021). Bridging the racial disparity gap in lipid‐lowering therapy. Journal of the American Heart Association, 10(1). https://doi.org/10.1161/jaha.120.019533
2. Rodriguez, S. and Yehl, K. (2020) Supporting Hispanic communities with a person-centered model of care, Thehuddle.simplecast.com. Available at: https://thehuddle.simplecast.com/episodes/supporting-hispanic-communities-with-a-person-centered-model-of-care-Vd9RSKCD (Accessed: Jul 04, 2023).
3. Bodicoat DH, Routen AC, Willis A, Ekezie W, Gillies C, Lawson C, Yates T, Zaccardi F, Davies MJ, Khunti K. Promoting inclusion in clinical trials-a rapid review of the literature and recommendations for action. Trials. 2021 Dec 4;22(1):880. doi: 10.1186/s13063-021-05849-7. PMID: 34863265; PMCID: PMC8643184.
4. Luther T. Clark, Laurence Watkins, Ileana L. Piña, Mary Elmer, Ola Akinboboye, Millicent Gorham, Brenda Jamerson, Cassandra McCullough, Christine Pierre, Adam B. Polis, Gary Puckrein, Jeanne M. Regnante, Increasing Diversity in Clinical Trials: Overcoming Critical Barriers, Current Problems in Cardiology, Volume 44, Issue 5,2019, Pages 152-153, ISSN 0146-2806, https://doi.org/10.1016/j.cpcardiol.2018.11.002. (https://www.sciencedirect.com/science/article/pii/S0146280618301889)
5. (No date a) Review of the Literature: Primary Barriers and Facilitators to Participation in Clinical Research. Available at: https://orwh.od.nih.gov/sites/orwh/files/docs/orwh_outreach_toolkit_litreview.pdf (Accessed: Jul 04, 2023).
6. Davis, A. (2018) PhRMA joins with National Minority Quality Forum and Microsoft to address diversity in clinical trials, The National Minority Quality Forum. Available at: https://www.nmqf.org/nmqf-media/phrma-joins-with-national-minority-quality-forum-and-microsoft-to-address-diversity-in-clinical-trials (Accessed: Jul 08, 2023).
7. Trends, charts, and maps (2023) ClinicalTrials.gov. Available at: https://classic.clinicaltrials.gov/ct2/resources/trends (Accessed: 29 July 2023).