It seems like we’re finally about to see a much-needed breakthrough in the diversification of clinical trials.
The Consolidated Appropriations Act, signed into law in December, made changes to the regulatory landscape that will require sponsors to consider diversity at every stage of clinical trials, making them more accurate and relevant to the United States patient population.
Consider that only 47% of U.S. clinical trials that took place over 20 years reported including patients who identified as White, Hispanic/Latino, Black, Asian, and American Indian, according to a study published last year. Latinos, Asians, and American Indians were underrepresented compared to their U.S. populations, while 21% of trials reported having zero Black enrollees and 10% reported being 100% White.
Trialbee CEO Matt Walz and Acclinate co-founder and CEO Del Smith recently held an open and honest conversation to discuss what’s creating urgency for those changes and why having adequate representation in clinical trials is more vital than ever. They also identified five ways to improve clinical trial diversity and why it’s the right time for each to happen.
1. Begin and sustain earlier patient engagement
It’s standard practice across the industry to receive a noncommittal answer when approaching someone to participate in a clinical trial. According to Smith, for people of color, longstanding trust issues in the health care system often lead to a more forceful response: “Hell no.”
If you want to change that, engage with underrepresented communities before you recruit individuals for your trial — preferably four to six months out. That way, when it’s time to offer them a spot, you know who’s most likely to take part. We’re starting to see a strong correlation between sustained, earlier engagement and the recruitment, enrollment, and retention of members of those communities in clinical trials.
Of course, trust still needs to be earned and nurtured. We must create what we call “affective trust,” which comes when people believe there’s a concern for their well-being. Our industry is recognizing it must lean into that emotional connection to generate results.
And just because a patient has been enrolled in a clinical trial doesn’t mean you should let that engagement fade. Maintaining it humanizes a patient’s journey, provides insights into their experience, and allows for a more informed approach to subsequent trials. More sponsors are starting to embrace this approach. Before long, it will be an industry standard.
2. Build trust through technology
Sponsors who get the most traction in clinical trial diversity don’t just engage with patients earlier. They take advantage of existing technology.
Robust platforms enhance patients’ experiences through virtual telehealth consultations and advanced pre-screening technology. Trusted digital communities bring together people with shared medical conditions and let them educate, engage, and empower each other. Tap into those networks.
Raise awareness of the clinical trial journey by sharing updates through app-based notifications, making video calls, and connecting them with others who have been in their shoes.
People are used to technology facilitating other aspects of their lives, but that same type of technology is rarely leveraged in clinical trial engagement. We must better use those technologies to properly educate patients on the journey ahead.
3. Leverage data to effectively raise awareness
Data is being used in site selection and outreach to prescribers, but it hasn’t regularly been incorporated elsewhere. Our sponsors have access to very rich data, and if we pressure them, we’ll uncover more of it.
Finding out how granular data can get will help us identify and engage diverse patient populations. Using three-digit ZIP codes will help us target outreach geographically, and tokenizing data — linking health and consumer data — will let us drive awareness with advertising.
And much like how we can let prescribers know about marketed medications or therapies, we should use that data to locate physicians to raise awareness of trials. Who better to tell a patient about access to a clinical trial than their physician? By trying these different models, we’ll learn together how to better reach health care organizations.
4. Apply what you’ve learned — and use it to keep learning
Patient data is one way to hone our outreach. Another is to incorporate information we’ve generated while tracking recruitment.
Sponsors typically fall into two groups: macro managers and micromanagers. A macro manager reviews data that show what vendors, sites, and contact research organizations (CROs) do to boost enrollment and let the process continue. A micromanager, meanwhile, works with data, identifies sites that don’t follow up quickly, and takes action. Enrollment outcomes are significantly better among micromanagers.
These platforms not only outline the journey for the patient. They let us take enrollment back into our hands. We then can solve the problem of diverse recruitment with increased interaction and qualification.
5. Understand the effect of a shifting regulatory landscape
The Consolidated Appropriations Act was signed in December, so we must quickly understand what’s coming in the regulatory landscape and work to advance the achievement of greater diversity.
Most notably, participation often creates a financial burden for those enrolled in clinical trials. Patients also face challenges getting to a trial site and taking time off work. Without adequate compensation, you’ve already limited your applicant pool. Providing it, however, recognizes people’s lived experiences.
Critics will say compensation leads to buying trust and doesn’t solve the diversity problem. Still, it’s not difficult to test incentive points to determine what’s fair and adequate and what would receive clearance from institutional review boards.
Progress results in a solution for everyone
It’s clear that in the coming year, increased access, awareness, and engagement will result in greater clinical diversity. Change won’t happen overnight, but it will happen at a faster rate than we’ve ever seen.
Remember, for our communities of color, you can knock on the door and tell them they no longer have to drive twenty miles. They no longer have to take time out of your lives. We’re going to bring all these resources to you. However, that person still has to open the door — and with proper reassurance, trust, and recognition of their hardships, they’re more likely to let you in.