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The Ongoing Quest for Greater Diversity in Clinical Trials

August 14, 2023

Boston as an Epicenter for Life Science Advances

As a hub for cutting-edge advances in biotech, digital health, medical devices, and pharma, as well as the home to several of the world’s leading academic medical centers, Boston is a global life science innovation powerhouse. That made the city an ideal place for the FINN Partners Global Health Practice to convene a discussion about building diversity in clinical trials – a topic critical to increasing health equity, as part of our Boston-centered Conversations In Health series.

The panel How to Maximize Diversity in Clinical Trials, in which I participated, featured an outstanding group of leading voices in the conversation surrounding the conduct of clinical trials, including neurologist Kemi Olugemo, MD, Decentralized Trials and Research Alliance (DTRA) co-chair Craig Lipset, and Tufts Professor Kenneth Getz.  My FINN colleague, Global Digital Health Lead Ritesh Patel, guided our conversation.

Our conversation is timely. Observers report that we may now be in a golden age of medicine. Science is making advancements in eliminating diseases that have challenged humanity for centuries. New drugs and devices are addressing some of our most persistent medical problems. These transformative innovations have at least one thing in common; they all began with patients participating in clinical trials.

Bean Town Long A City Proclaiming Justice

But these advancements have not resulted in equitable benefits for all people. Reports confirm that white males are disproportionately represented as study participants in U.S. clinical trials, with people of color, LGBTQ+ patients, and those in underserved urban and rural communities largely unable to access research. Because genetic makeup, physiological responses, and disease susceptibility vary across races, ethnicities, genders, and locations, we fail to develop drugs optimized for all patients needing them.

Inclusivity in clinical research translates into more expansive data on how various populations will respond to anticipated medical miracles. That data is critical in developing personalized medicines and clinical solutions that are proven effective for many rather than a select few. Attaining that knowledge for a broad group of patient populations is critical to democratizing medicine and improving patient outcomes.

While panellists acknowledged progress, we spoke candidly about the vital work to meet goals for more diverse participation in clinical trials. Key themes and insights emerged from our discussion.

Clinical trial disparities persist, especially in exploring solutions for often deadly diseases:

“I have seen the pendulum swing many times in terms of focusing on health equity and diversity, yet we don’t see much improvement over the last decade. The disparities are highly pronounced, especially when you look at certain disease states,” Ken Getz related. The figures in recent analyses of therapeutic trials for cancer drugs confirm this; only 4%-6% of trial participants are Black and 3%-6% are Hispanic, despite 15% and 13% of these communities respectively presenting with cancer.

The trust isn’t there with diverse populations:

We agreed that trust in clinical research is lacking among BIPOC communities, and that one-off approaches or isolated efforts to close the persistent clinical trial trust gap stumble – predictably. A comprehensive program that makes consistent use of community-based clinical trial participation, promotes patient accessibility to complete trials, presents education programs that lower health literacy barriers, works with more diverse sponsors, and leverages health ecosystem incentives is needed to increase overall societal receptivity to enrolling in a clinical trial. These programs must be part of pharmaceutical and medical device company trial planning and execution.

Activities that favor participants with economic ability and mobility exclude minorities:

While decentralized trials can access more diverse participants, we recognized that systemic barriers based on social determinants of health remain stumbling blocks. Kemi Olugemo commented, “Much of what we do to expedite enrollment is focused on people who have means – people who have means when it comes to technology and people who have the means to get to the site. The decisions we make, like using a patient concierge, for example, actually favor those who already have access. We must live with and grapple with these hard truths if we are to make progress.”

Trial conduct should recognize that all healthcare is local:

Engaging health providers who reflect demographically the communities trial sponsors seek to engage is key to improving awareness, referrals, and data quality. Ken Getz related the results of a study conducted at Tufts, which found that “the number-one predictor of patient enrollment diversity was the diversity of the study staff.”

Put patients at the center:

As we discussed, too often, clinical trial protocols don’t reflect input from patients about the endpoints that matter most to their quality of life or how accessible a trial is to them. Protocol simplification can help broaden eligibility and participation, but drug companies tend toward conservatism, and resist significant disruptions to existing models. Our panel’s consensus is that pharmaceutical companies need to treat patients like key opinion leaders and boost long-term engagement by establishing patient advisory boards and health and wellness registries or observational, all-comers registries. In addition, sponsors need to be better about inviting patients: “There are many communities where trust is not the issue; patients are just not being invited to participate,” said Craig Lipset.

Federal guidance is not enough:

The adage that “we respect what we inspect” holds. In addition to voluntary efforts on the part of some sponsors, policy-level changes that provide guardrails for sponsors are needed. Kemi Olugemo said, “When you look at the COVID trials, people used master protocols…they standardize the way we conduct trials, and there was also a requirement to enroll a certain proportion of communities of color and people were successful. I see those as areas of progress.”

Stronger incentives and accountability mechanisms would also accelerate progress.  “Rare disease drug development didn’t just happen because someone produced guidance saying we could do it,” added Craig Lipset. “It happened because we created the carrots and incentives that changed the dynamic of drug development.”

Science, Diversity and Personalized Approaches

Finally, our panel concluded that every trial is different. Diversity efforts cannot succeed by determining a “one size fits all” blanket approach valid for all drugs and all trials. Sponsor mindsets need to shift, and participation by different patient populations needs to be reviewed on a trial-by-trial basis; different drugs for different disease states require tailored engagement approaches for diverse patient populations.

It was a thrilling conversation that could only take place in Boston, the city at the cutting-edge of medical, technological, and pharmaceutical innovation.  We agreed that diverse clinical trial participation would remain an innovation Achilles heel until we address fundamental access barriers and establish fruitful community partnerships that involve the physicians and patients we need to reach for each drug and disease state.

Diversity in clinical trials is not just a matter of fairness and sound science but is a social responsibility. By embracing efforts to establish clinical trial diversity, we foster a more equitable and inclusive healthcare system where the drugs and devices we develop are purpose-built for the patients who need them most.

TAGS: Health

POSTED BY: Fern Lazar

Fern Lazar