Addressing the Diversity Challenge in Clinical Research Through Patient Advocacy

Diversity is paramount to the success of clinical research, both ethically and scientifically. Without adequate representation of racial and ethnic minorities, investigators lack an understanding of the safety and efficacy of novel treatments within those groups. From a scientific standpoint, an incomplete dataset hinders drug delivery and the development of breakthrough therapies – but from an ethical standpoint, underrepresentation creates a barrier to treatment options for populations that are often the most vulnerable and predisposed to health challenges. 

According to a 2021 study assessing 230 U.S.-based trials, 40% did not report the race of trial participants, and of those that did report race, 78% of participants were white. For well over a decade, stakeholders have worked to uncover and address barriers to achieving representative enrollment in clinical research. Regulators have increasingly prioritized diversity in clinical trials, with the FDA releasing draft guidance in April 2022. However, data indicate that clinical trial enrollment does not align with the diversity of the population – in fact, participation of racial and ethnic minorities in clinical research has actually decreased over the past 14 years. Participation for African Americans has been significantly declining, including a 35% drop in 2020–2021 from 9.8% to 6.5%. 

Addressing these disparities is imperative to clinical innovation – without representative diversity, investigators lack the necessary comprehensive data to accelerate drug delivery and breakthrough, life-saving therapies. Improving enrollment in underrepresented populations requires the following: Patient Advocacy Organizations that foster trial education and awareness, technologies that alleviate the patient burden/participation barriers and advanced data technology solutions that identify and match patients to clinical trials. 

The Role of Patient Advocacy Organizations 

Patient Advocacy Organizations play a critical role in cultivating diversity in clinical research, serving as a liaison between lawmakers, healthcare professionals, and minority communities. Dedicated to ensuring health equity and access, these organizations provide patients with resources to broaden their awareness of clinical trial opportunities, along with key talking points to discuss with their providers. In empowering patients with the necessary resources, education and guidance to advocate for themselves, Patient Advocacy Organizations develop trust between patients and the medical system, ultimately bringing the industry one step closer to alleviating racial and ethnic enrollment disparities. 

One of the many ways Patient Advocacy Organizations work to address diversity and ease the patient burden is through the use of advanced data technologies. Clinical health data registry platforms can help stakeholders cultivate diversity by matching trial candidates based on inclusion criteria resembling the diversity of the overall population. These advanced technologies not only match underrepresented patients with clinical trials they may have otherwise been unaware of, but also create ‘health wallets’ that provide patients access to their health data, so they are empowered to advocate for themselves when discussing treatment options with providers. Patient Advocacy Organizations streamline touchpoints between patients and researchers throughout the research process, ensuring patient data is effectively utilized to accelerate innovative treatment options. This collection, storage and analysis of diverse data types drives innovation and improves patient care. 

Barriers to Participation for Racial and Ethnic Minorities 

There is a common misconception that the reason minority patients are underrepresented in clinical research is that they are not interested in participating – this assumption fails to critically consider the complex factors that perpetuate disparities. To address diversity challenges, stakeholders must abandon these oversimplifications and work to remediate common barriers to enrollment for racial and ethnic minorities, including: 

Awareness of clinical trials

One of the most notable barriers to trial enrollment is a simple fact that certain patients are not being asked to participate. Too often, the clinical research industry fails to reach community providers who typically comprise the regular source of care for racial and ethnic minorities, perpetuating distrust in the clinical research process. Conversely, patients (a majority of whom are white) with ties to academic research institutions have a built-in advantage when it comes to clinical trials. Providers affiliated with these institutions are privy to information surrounding existing trials and have more connections to point patients in the direction of enrollment. Patient Advocacy Organizations work to mend this disconnect by equipping underrepresented patients with the tools they need to stay apprised of upcoming clinical trial opportunities and cultivating relationships between these patient populations and research institutions. 

Overall distrust of medical establishments 

Given the historic exploitation of minority groups in medical research and in the healthcare system, it comes as no surprise that these patients are more likely than their white counterparts to mistrust healthcare organizations and less likely to take medical advice, keep follow-up appointments or fill prescriptions. This poses a significant barrier between minority patients and the clinical research industry. Although rectifying this distrust will take time, Patient Advocacy Organizations work with both patients and practitioners to break down barriers by ensuring that patients have the resources they need to advocate for themselves. As patients become more involved, it will be critical for practitioners to ensure that they are communicating in a way that resonates with these underrepresented communities. 

Financial burdens

In the U.S. especially, affordable healthcare depends on having health insurance. Research shows that people of color fare far worse than their white counterparts in the areas of health insurance coverage, access, health status, outcomes, behaviors and social determinants of health. On top of this disparity, clinical trial participation can be incredibly costly. Site locations are sometimes hundreds of miles away, leaving participants to shoulder the burden of travel costs, hospital expenses and parking fees for each on-site visit. Participants must also account for time off, childcare and additional cost risks for their caregivers. Through advanced data technologies, Patient Advocacy Organizations can create patient registries allowing those who might not be able to participate in a traditional on-site clinical trial to share their data for research. Capturing these insights helps address financial, geographic and exclusion criteria barriers to participation.

Understandably, patients can be reluctant to discuss these financial concerns with physicians, and both patients and physicians often lack the tools and expertise to facilitate these important conversations. Patient Advocacy Organizations not only continuously advocate to lower drug prices and the overall cost of care, but also to establish cost transparency and coordinate these conversations. 

Advanced Data Technologies and Patient Advocacy – the Key to Cultivating Diversity 

The future of clinical innovation depends on enrolling participants that represent the diversity of the entire population. To achieve health equity so all can benefit from clinical advancements, the clinical research industry must address the most common barriers to participation, including lack of trial awareness and access, distrust of the medical system and financial burden. Equipped with advanced data technologies, Patient Advocacy Organizations are uniquely positioned to match the right patients to the right clinical trials and cultivate relationships between providers and underrepresented patient populations. 

Andrew Barnhill, Head of Public Policy, Global Legal, IQVIA

Andrew Barnhill is a healthcare government affairs executive with experience at Fortune 500 companies and a diverse set of healthcare coalitions and political campaigns at the state and federal level. Named by “The Hill” as a 2022 Top Lobbyist, Andrew currently serves as Head of Policy at IQVIA. He was the 2016 Democratic Nominee for North Carolina Senate in the 9th District in a competitive race that garnered national attention by multiple national news outlets where he was endorsed by President Obama. A graduate of Furman, Duke, and the University of North Carolina, Andrew is a native of the North Carolina coast and lives in Washington while commuting to Manhattan for his service on the faculty of NYU’s Wagner School.

Alexandra Weiss, Director of Strategic Partnerships, Patient Advocacy Organizations, IQVIA

Alexandra Weiss has an extensive background in patient advocacy and is a patient and caregiver advocate herself. She currently serves as Director of Strategic Operations for Patient Advocacy Organizations at IQVIA. Prior to joining IQVIA, Alexandra spent over six years leading industry relations and engagement for an oncology patient advocacy organization. While there, she worked closely on their Scientific & Medical Initiatives, raised funds to drive progress, and represented the patient voice for industry-hosted initiatives. Alexandra has spent over a decade in philanthropic leadership roles most recently as chair of her local hospital’s cancer institute board.

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