Conversations about clinical trial diversity have finally gone mainstream, but the numbers haven’t quite caught up. Improvement may rely on homing in on one key aspect: informed consent.
“Informed consent and diversity have always been linked in some fashion,” Stephanie Agu, an attorney at Hogan Lovells who advises life sciences and healthcare clients on regulatory issues, told Fierce Biotech in an interview. Informed consent promotes trust and understanding between patients and researchers, she added later, and can attract and retain people who are traditionally underrepresented in research.
Representation and regulation
U.S. regulators have tried to bring underrepresented patient populations into trials for years, but the 2020 Black Lives Matter movement thrust the subject into the spotlight. While the diverse recruitment plans laid out in the 2022 Food and Drug Omnibus Reform Act are the culmination of efforts that predate the movement, the guidance still holds trial sponsors accountable for making sure their drugs and devices are tested in a diverse patient population, Agu explained.
“If a sponsor is falling short on their enrollment goals, for example, then that initiates a conversation between FDA and the sponsor as to why that didn't happen,” she said.
Underrepresented groups’ hesitation to take part in biomedical research “largely stems from distrust in researchers,” Justina Tavana, Ph.D., a scientist at Brigham Young University who conducts Alzheimer’s disease research involving people from Samoan and Pacific Islander communities, said in an interview with Fierce. “It also comes from a lack of familiarity with research protocols and feelings of apprehension.”
Some of that distrust can be traced back to nightmarish studies like the Tuskegee syphilis experiment, in which medical care was withheld for hundreds of Black men without their knowledge or consent. Data suggest that the experiment still makes some Black individuals hesitant to take part in research and healthcare more broadly (though there are plenty more reasons, too).
Between justified suspicion toward the system, a lack of awareness into how clinical trials work and general nervousness about being a medical research subject, sponsors have an uphill battle when it comes to enrolling marginalized patients.
“Knowing that those are some of the obstacles you’re probably going to face, you need to figure out how you’re going to overcome them,” Tavana said. “And informed consent is extremely important to that.”
Establishing trust
Though informed consent often evokes images of thick packets of forms, the process is much broader than that and starts long before it’s time to read the fine print, Agu said.
“The FDA considers recruitment itself to be the start of the informed consent process,” she explained. Key features of informed consent include disclosure of all details about the trial—from how far a subject may need to travel to get to a research site to potential side effects—as well as verification that potential enrollees understand what their commitment entails and are taking part voluntarily, Agu added.
To Agu, the same strategies deployed to increase trial diversity overlap with the informed consent process. For instance, rather than go through physicians, sponsors should meet patients where they’re at (literally) via paradigms such as community-based clinical trials. Sponsors who want to reach individuals outside the medical system, she added, are “going to barber shops … going to parks, going to places of worship, hosting barbecues—going to patient communities and to the patients’ caregivers and speaking with them about clinical trials.”
Tech entrepreneur Ashley Nealy, who is Black, participated in an early trial for the COVID-19 vaccines and has volunteered with the Center for Info and Study on Clinical Research Participation, or CISCRP, to advocate for clinical trial participation in the Black community. Her experiences have underscored the concept that documentation is one of the last steps in informed consent, not a starting place.
“The form comes once you’ve already decided to sign up for a trial,” Nealy said. “You already have them in the door if they’re looking at an informed consent form.”
A multifaced approach
Multimedia can be a helpful tool to solidify informed consent practices from beginning to end. Tavana’s research teams create videos that outline a research project’s objectives and requirements and emphasize subjects’ right to withdraw at any time. All materials are available in every Pacific Island language, making them more accessible and inclusive. This “multifaceted” approach to informed consent makes participants both willing and enthusiastic before, during and after research, she said.
For Nealy, the best way to counter the skepticism she has encountered from other members of the Black community is transparency and honesty—the core tenants of informed consent.
As an advocate, Nealy finds it helpful to explain clinical trials in relation to already approved medicines and that those treatments exist because people stepped up as trial volunteers.
“It also helps to explain that yes, medical racism is real, but look at the communities that are signing up for these trials," Nealy said. "Why are we allowing other communities to try to get better, but not our own, sometimes?”
Good for patients, good for sponsors, good for medicine
Robust informed consent practices take time, but they’re essential if sponsors want to make trials appealing to underrepresented populations, Agu said.
“I think these efforts make clinical research more accessible. And we know that by making clinical research more accessible, we are expanding the scope of participants that see clinical research as a viable option for them,” she explained. “I think the effort to improve informed consent processes will directly or even indirectly have the impact of diversifying clinical trials generally.”
Wide-ranging informed consent practices also help patients feel more empowered, which can make them not only more likely to participate in research but also gives them a greater sense of agency in their broader medical care. Tavana has witnessed this firsthand among those who participate in her Alzheimer’s research. And it’s not just patients who benefit, she noted: From her perspective, informed consent is integral to a study’s validity.
“When the participants are informed and have been given a clear understanding of their involvement, then they’re able to provide more accurate information and comply with study protocols," Tavana said. “It enhances the quality of our data.”