Advancing Diversity in Clinical Trials: Building Awareness and Implementing Solutions to Enable Broad Participation in Research

The lack of diversity in clinical research is a problem. While there are many reasons for underrepresentation, lack of awareness and mistrust of the system compounded by the burdensome nature of trials rise to the top. The result? Imprudent science.

In this blog, I review statistics documenting the underrepresentation of certain populations in clinical trials, plus ways we, as the collective industry, can overcome these imbalances, through a combination of awareness, education and patient-centric solutions.

A Lack of Diversity in Clinical Trials

Blacks, Latinos, Asians, and others are significantly underrepresented in clinical research in the U.S. According to U.S. Census data, black or African Americans represent 13.4% of the U.S. population, yet the FDA reports that those populations make up only 5% of clinical trial participants. The disparity is even greater for those of Hispanic or Latino origin. They represent 18.1% of the U.S. population but only 1% of clinical trial participants. Diverse segments of the population can react differently to medicines, so it’s imperative that sponsors, CROs and sites find ways to enroll and retain a broad spectrum of individuals in research.

“Drug developers recognize the importance of participant demographic representation in the development of safe and effective medical treatments,” Ken Getz, deputy director of the Tufts Center and principal investigator, told the ACRP of a new study his agency conducted on diversity – the Tufts CSDD Impact Report.

In it, his team dug into the demographics of 371 clinical trials for new drugs and biologics approved in the U.S. from 2007 through 2017. Despite decades of work by the FDA, the National Institutes of Health, patient advocates, and Congress, Tufts recognized that there continues to be a disparity in the volunteers who participate in clinical research.

And if we look at trends, we see that certain conditions and diseases are on the rise amongst certain populations. For example:

• By 2040, over half of U.S. people living with Alzheimer’s disease will be black or Hispanic
• By 2045, breast cancer in the US will increase by 72% in black people, 89% in Hispanic people, and 120% in API
• By 2050, Alzheimer’s disease cases in China will account for half of all global cases

We need to do everything possible to help increase awareness and access to clinical trials for people of all backgrounds.

What Can the Clinical Trial Industry Do to Be More Inclusive?

Our Greenphire employee values are All In, As a Team, For a Purpose, Solving Problems.

We recently asked employees what more the industry can do to increase diversity in clinical trials. Their answers centered on education and awareness for all stakeholders. Here’s what they said:

Start with the Sponsor: Greenphire employees emphasized two items – recognizing the patient burden incurred in clinical trials and modelling diverse leadership.

• • “Eliminate some of the criteria in order for patients to participate”
  • “Ensure sponsors as wells as CRO’s are implementing diversity in clinical trial programs and developing thought leadership around their strategies and ways of implementing them.
  • Set requirements for numbers or percentages of participants from diverse populations (provided they are impacted by what the study is researching)

Engage the Sites: You need outreach to more and different sites than before, as well as educating sites about the utmost importance of diversity in medical research. Here’s what Greenphire colleagues said:

• • “Don’t just involve large sites that get a lot of traffic through them. Try to get a good demographic of where an indication is prevalent and create diversity by including sites that wouldn’t normally be included.”
  • “Put forth educational materials for PI’s and their staff.”
  • “Convey trust via the MD”

Outreach to Patients: As we’ve seen, traditional outreach has not sufficed in terms of bringing diverse populations into clinical trials. But what more can be done? Employees suggest:

• • “Make participation easy”
  • “Provide education to certain areas where diverse recruitment can occur. I believe certain ethnicities don’t participate in clinical trials because they don’t fully understand how they can help! Education is key!”
  • “Engage church and community groups”
  • “Reimburse travel or provide rides to visits”

Solving for Financial and Logistical Burdens: ClinCard and ConneX

The publication “Current Problems in Cardiology” recently published Increasing Diversity in Clinical Trials: Overcoming Critical Barriers, and in it, detailed the critical obstacles to participation in clinical trials. Factors such as mistrust and fear are stigmas which have historically contributed to low enrollment levels and require ongoing education. Yet there are immediate opportunities to improve – namely appreciating the time and resource constraints associated with clinical trial participation, of which people of different ethnic backgrounds may face at higher levels. These can be accomplished through:

• Make clinical trials more patient-centric: Remember, your clinical trial participants aren’t just patients – they have jobs, families, community responsibilities and more. While the goal of your clinical trial is to collect data, for the participant, the visits must not be overly burdensome so that they don’t enroll or drop out early.
• Reimburse for out-of-pocket expenses and/or time: Clinical trial participants spend their time preparing for and going to appointments. These visits take time away from work, can incur additional childcare or eldercare fees, and more. Recognizing this sacrifice by reimbursing the patient for their time and effort is one way to show appreciation and value to the overall research.
• Provide transportation: Individuals who may normally rely on family members or public transportation to attend visits. Especially in light of COVID-19, providing for safe and sanitary transportation is of the utmost importance. Retaining clinical trial participants is crucial to trial success.

In 2019, the FDA introduced guidance intended to “Enhance the Diversity of Clinical Trial Populations.” While some of the suggestions centered on eligibility criteria and enrollment practices, they also specifically reinforced ways to “…make trial participation less burdensome for participants.” These include making participants aware of financial reimbursements for expenses associated with costs incurred by participating in the clinical trial (travel and lodging), as well as using technology and reducing the frequency of visits.

How can Greenphire Help? Patient-Centered Solutions and Education to Move the Needle

Greenphire employees take pride in knowing that our suite of patient convenience solutions can remove the financial and logistical burdens from patients.

However, we’re committed to much more, including:

• Further employee engagement: we value each and every one of our employees and the diverse points of view each individual contributes to the fabric of our company. We continue to evolve and provide opportunities for employees through diversity and inclusion training and formalizing our internal employee diversity committee.
• Partnerships with organizations that are making a difference: Whether those are clients who are committed to making a difference, or industry organizations such as CISCRPS, we support working with others whose mission is to expand access to clinical trials.
• Sharing stories: We want to put the spotlight on you – how are you making a difference in terms of healthcare equity? Email marketing@greenphire.com to let us know.

Call to Action

We encourage you to join in this moment. What can you do to make a difference for the future of medical research and healthcare equity?