Facing the challenge of diversity and inclusion in clinical trials

Diverse and inclusive participation in clinical trials is a long-standing goal of three highly motivated communities: patients, medical researchers, and clinicians. But despite sincere efforts and decades of attempts, too few trials currently include patients who actually represent relevant demographic groups (including age, ethnicity, gender, and race) and non-demographic categories (such as people with disabilities or those with comorbidities).

In 2021, why is this essential goal still an aspiration, rather than an achievement? After all, the purpose of clinical trials is to develop therapies and other products that clinicians can use to prevent, diagnose, and treat diseases among their patients (think: screenings and treatments) or the world (think: vaccines) safely and effectively. Lack of diverse and inclusive participation in clinical trials contributes to poorer health outcomes, higher costs of treatment (because of later diagnosis), and even early death among people of African, Hispanic/Latino, and Asian descent, as well as American Indians and those from low-literacy communities—all of whom have historically experienced health inequities and from whom health-related advancements have been withheld.

Signs of progress in the fight for representative clinical trials

Change is on the horizon. The U.S. Centers for Disease Control and Prevention (CDC) this month declared systemic racism and inequity in the United States a public health threat, announcing its commitment to confronting the systems and policies that have resulted in the generational injustice that has given rise to racial and ethnic health inequities. The CDC's declaration follows on that of many other groups that have recognized the historical and current impacts of racism on the health of people of color. Medical innovations and treatments have too often been denied to these populations, yet clinicians and medical researchers routinely state that more diverse clinical trials would yield stronger results.

So, what’s being done to improve diversity and inclusion in clinical trials? The global pandemic and the worldwide race to develop COVID-19 vaccines and treatments that will prove safe and effective for all people—regardless of demographic—has further highlighted the need for more diversity in clinical trials. For decades, communities of color have faced disproportionately higher rates of cancer, heart disease, diabetes, and other diseases, as well as worse health outcomes and higher death rates due to these conditions, as noted above. In the past year, the same patterns were repeated with COVID-19, with one consequence being that trial sponsors, medical researchers, and clinicians refocused efforts on diversity and inclusion in all clinical trials. There is an appealing “fresh start” taking place right now, and two leaders have issued new recommendations:

• The U.S. Food & Drug Administration (FDA) recently stated that despite decades of promoting practices designed to lead to participants being recruited from populations most likely to use a product, many groups are still underrepresented in clinical trials—and that must change. The FDA issued guidance recommending modifications in eligibility criteria, enrollment practices, and designs.
  
  
• The Pharmaceutical Research and Manufacturers of America (PhRMA) announced steps to address systemic racism. These include new principles and commitments expected of PhRMA members to improve diversity and inclusion in clinical trials. PhRMA called for members to acknowledge past wrongs, enhance diversity among medical researchers, advance health literacy and community outreach about clinical trials, improve ease of access to clinical trials, and take diversity and inclusion into account when planning and implementing clinical trials.

How clinical trial sponsors can meet the moment

Following the FDA guidance and adopting the PhRMA principles and commitments will require significant change for most companies and government entities that sponsor clinical trials. These changes include:

• Acknowledging the role that systemic racism has played in clinical trial recruiting and in medical research and development
• Applying messages and actions that are centered on trust, respect, acknowledgement of past trauma, and a dedication to diversity and inclusion
• Implementing audience-focused, multicultural, and multilingual clinical trial recruiting that clearly demonstrates a commitment to a new path forward
• Creating authentic and inclusive communication that follows the best practices of health literacy, social marketing, behavior change, grassroots outreach, and partner engagement
• Revamping measurement and reporting metrics to evaluate progress and success

Words without action, and commitment without a roadmap, will continue to thwart progress.

At ICF Next, we’re helping clients navigate these and other complexities. Our team of multicultural healthcare communications experts applies an audience-focused lens to spark change, increase awareness, and build trust in communities. There are tens of millions of underrepresented people who deserve better healthcare and more inclusive clinical trial environments. Clinical trial sponsors and medical researchers need to make room for them, seek them out, and ensure they are included. To create meaningful change, a thoughtful and iterative process is necessary, and transparency and steadfast dedication are required.