Decentralized Clinical Trials: Keys to Optimizing Diversity and Inclusion

Written by Michael Delisle, Vice President, Practice Leader for Digital Health

The U.S. pharma industry and research intuitions have long struggled with increasing clinical trial diversity in an effective, sustainable, and scalable fashion. Clinical research, in general, acknowledges the universal struggle of recruiting enough participants from various demographic groups. For example, racial and ethnic minorities have been historically underrepresented in clinical trials—a problem that still persists today.

According to Deloitte, African Americans comprise 13% of the U.S. population but only 5% of clinical trial participants. Meanwhile, whites comprise 67% of the U.S. population but account for the majority of research participants at 83%. Clinical trials have also struggled to garner enough female candidates, often defaulting to male-dominated data as a result.

Research suggests that heart disease, cancer, and diabetes symptoms vary by ethnicity and between genders. Consequently, if diverse groups aren’t part of research studies, it’s challenging to establish treatment equity or the full scope of potential side effects. Helping solve the diversity challenge would lead to more reflective data on drug efficacy and treatment options.

Common barriers to traditional clinical trial participation include lack of comfort with the clinical trial process, time and resource constraints, and a general lack of awareness about the existence and importance of clinical trials. Economic and geographical concerns also play a role, as low-income patients might lack adequate resources to pay for travel, childcare, and time away from work to participate. While financial incentives and transportation services are viable solutions, it’s the use of mobile applications and telehealth technology that seems to have the most significant potential to improve participation in decentralized clinical trials.

Inclusive Patient Recruitment – An Immediate Improvement to Better Outcomes

Decentralized clinical trials’ promise of creating digital access via remote enrollment tools, consent forms, and data capture will help reduce the aspects of trials that underserved populations consider time-consuming and cost-prohibitive. By reducing onsite interactions, participants will save on travel time and expenses and not incur childcare costs or lost wages due to missing work. According to The National Academies of Sciences, nearly 70% of potential participants live more than two hours away from trial sites—limiting their access to possibly life-saving therapies.

Those digital conveniences mentioned will help extend a clinical trial’s potential reach. However,

Decentralized clinical trials will have to offer more than a digital fingerprint to touch those who are underrepresented in clinical research. Sponsors, tech developers, and healthcare providers will have to go beyond the biases to attract a more diverse set of potential candidates. During research as a digital health and life sciences executive recruiter, I’ve identified three critical elements DCTs must employ to optimize diversity and inclusion in future clinical trials.

1. Human Trust

Several factors have led to mistrust among underrepresented populations and healthcare providers. From historical events like the Tuskegee Syphilis Study to more subtle experiences of dismissal and discrimination, there is work ahead to build trust amongst BIPOC populations. Developing outreach opportunities that reflect the concerns and needs of underserved populations will be paramount in creating effective touchpoints with potential trial candidates both on and offline. In addition, hybrid clinical trials will have to establish best practices with onsite staff to create a culture reflective of embracing these same populations.

2. Effective Communication

Variations in literacy, formal education, and English language proficiency are all roadblocks that stand in the way of clinical trial diversity. Sponsors and companies specializing in clinical trial recruitment will have to continue to address these disparities by finding ways to communicate to these populations effectively. For example, utilizing applications that include various mediums and features such as audio, video, and gamification can help breach language and literacy gaps. Likewise, developing multi-language outreach and educational materials will be paramount in creating this type of engagement.

3. Collaborative Representation

As decentralized clinical trials evolve, so will the data that comes from them. Optimistically, the insights drawn from the research will lead to the tools, practices, and approaches that are more representative of potential trial candidates. Trial organizers will have to be more thoughtful in engagement and communication with candidates from underserved populations to kick off these efforts. Do they have trial sites with accommodations to address a specific demographic’s unique needs and concerns? Can local healthcare providers create meaningful partnerships to provide greater awareness and more personalized approaches regarding trial opportunities? The more that potential candidates can also see themselves represented in the objectives and messaging of clinical research, the more likely they will be inclined to participate.

The ever-evolving digital landscape in U.S. healthcare will continue to help transform the decentralized clinical trial process organically and increase the diversity of the candidate pool in the future. However, to truly sustain those virtual efforts, Pharma and research institutions will have to remember the importance of inclusion and connection with all communities: gender, race, age, and otherwise, to produce data that is representative of the lives we seek to serve and save each day.