Clinical trial diversity not only allows for a better understanding of the safety and efficacy of new therapies in population subgroups but also plays a significant role in reducing health inequities. In conversation with PharmaBoardroom, outgoing president and global chief executive of the Drug Information Association (DIA) Barbara Lopez Kunz, speaks about the progress that has been made in increasing the diversity of clinical research, the impact that remote trial participation can have, and industry’s response thus far.
Diversity on the Agenda
“Diversity in clinical trial development is finally an important topic within our healthcare system,” says Lopez Kunz. Although DIA – an association that brings together regulators, academia and industry to collaborate and problem-solve on the global and local challenges facing the life sciences field – is a global organisation, it is based in the United States. While the US is home to the world’s largest pharmaceutical and medtech market and many of the planet’s leading healthcare facilities is often pinpointed for its healthcare disparities. According to the FDA’s 2020 Drug Trials Snapshot, 75 percent of the 32,000 patients who participated in clinical trials that year were white, while only eight percent were African American, six percent Asian and 11 percent Hispanic. Within this context, the fact that discussions about clinical trial diversity have begun is even more significant.
Diversity in clinical trial development is finally an important topic within our healthcare system
For Lopez Kunz, dialogue has led to progress. “For example, the FDA instituted the draft guidance Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Subgroups in Clinical Trials this past April. We have also seen the Multi-Regional Center of Brigham and Women’s & Harvard initiate comprehensive efforts to increase diversity in clinical trials while simultaneously addressing some systemic barriers to clinical trial participation,” she says.
The Challenge of Engaging Diverse Communities
One of the difficulties Lopez Kunz identifies is the need to reach out to diverse communities and gain their trust. “Engaging diverse communities can be a challenge for organizations. Building a sense of trust within systems and communities so that participants have a clear understanding of what to expect as well as the benefits of participating clinical research is one key,” she states.
According to Lopez Kunz, industry stakeholders are taking a more grassroots approach to engaging more patients in clinical studies: “I have seen thought leaders in health and life sciences conduct outreach to their communities to educate on health care, clinical research, and why it is important to be engaged in one’s health.” She expresses her confidence in the combined efforts of these initiatives: “We need to support small and large efforts which together will help to propel representative populations in clinical development.”
Progress on Remote Participation
Another approach to removing barriers and improving clinical trial diversity is through remote participation, a trend that was accelerated by the COVID-19 pandemic, subsequent lockdowns, and a decrease in willingness to attend healthcare facilities in person. “Decentralized trials aim to create a more distributed system instead of a centralized operation to which participants must accommodate. The need to include diverse trial participants requires a complete rethinking of these considerations in the original protocol development,” Lopez Kunz comments.
We must ease the clinical trial burden to encourage participation for patients who live far from these health centres must deal with the burden of travel
Barbara Lopez Kunz
“We must ease the clinical trial burden to encourage participation for patients who live far from these health centres must deal with the burden of travel, as just one example, and consider factors such as the financial constraints of participation and develop a perspective on how we can overcome these access challenges,” she continues.
In Lopez Kunz’s view, technology is key to enabling remote participation: “Effective devices and technologies allow remote monitoring of physiological symptoms through wearable technologies that allow professionals to access needed data.”
DIA plans to take an active part in developing remote trials. “There are many complexities that must be further developed, and DIA will play a role in convening stakeholders, sharing best practices, and offering educational opportunities to enable the advances,” she confirms.
Getting Companies Onboard
With clinical trials now without doubt the most expensive part of the drug development process, Lopez Kunz expresses the need to develop more efficient procedures to reduce costs. “In most innovations, there is a need to thoroughly evaluate conventional methodologies in parallel with novel approaches to ensure benefits are realized. This work should culminate in more streamlined processes that are time- and more cost-efficient. This is where we are heading on the pathway to ensuring diversity in clinical trials and the adoption of decentralized processes.”
Big Pharma appears to be ready to take on the costs involved in improving clinical trial diversity and as Stephen J. Ubl, president and CEO of PhRMA, said in a recent PharmaBoardroom interview, “on clinical trial diversity, 84 percent of PhRMA members are committing energies towards partnerships with local communities to improve clinical trial diversity.”
Yet for small biotechs the cost of clinical development remains a challenge. “Until new approaches are developed, proven, and adopted by early innovators, we must be patient. Details are under development, and DIA is in the mix of this evolution,” says Lopez Kunz.
To this effect, DIA has been increasing its activity around diversity. “We were early in convening our community on the topic of Diversity in Drug Development, a conference we have held since 2020,” Lopez Kunz confirms. “We are also developing a training course on decentralized trials to help our community remain on the forefront of the evolution. Much more will emerge as the work continues.”