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Revolutionizing clinical trials

Jim Kirby, chief commercial officer at Kroger Health, discusses how organizations can make clinical trials more diverse and accessible.
jim kirby
Jim Kirby, PharmD, BCPS, FAPhA
jim kirby
Jim Kirby, PharmD, BCPS, FAPhA

Historically, clinical trials have fallen short when it comes to representing diverse populations, and conversations around these gaps have been growing louder. An FDA study conducted between 2015 and 2019 discovered that 78% of clinical trial participants were white, and most were clustered in three states: California, Texas, and Florida. This study revealed an absence of voices from underrepresented communities in U.S. clinical trials, undermining the very foundation of equitable healthcare.

We can and must do better to ensure all communities are reflected in health research, and there are countless incentives to do so. Research suggests that diversifying the studied patient groups in clinical trials could help unlock innovation and accelerate the delivery of life-changing treatments. In addition, different patient populations may exhibit distinct medical responses to investigational drugs or therapies, and by underrepresenting specific demographics we risk compromising the quality of care.

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When we include a diverse group of people, it means we can achieve better health outcomes for everyone. As a pharmacist by training, I believe the retail health sector is uniquely positioned at the intersection of healthcare and community to improve day-to-day health outcomes and revolutionize how we approach research and patient care. It’s time to drive meaningful change in clinical trials, removing key barriers and ensuring that every voice counts.

In May 2023, the FDA announced new guidelines to advance the model of decentralized clinical trials. Initial DCT guidance released in 2020 as a response to COVID-19 allowed trial-related activities to occur at participants’ homes or other convenient locations, increasing the protocol options of how clinical trials are conducted when people cannot get to a trial site.

The updated guidance indicated that trial-related activities can, and should, continue beyond traditional clinical trial sites and also provided stakeholder DCT recommendations. It is expected that DCTs will increase the breadth and diversity of clinical trial participation, improving accessibility for patients who have previously faced barriers to clinical trials.

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Clinical trials have historically had a number of access barriers for patients. Geography has remained one of the primary limiting factors, with more than half of patients not having access to trials at a localized treatment center in or near their communities. In the past, becoming a trial participant has largely been hampered by lengthy time commitments or expensive travel plans related to getting to a specific clinical trial location.

Additionally, an analysis from the National Cancer Institute revealed that a mere 9% of Americans reported ever receiving an invitation to participate in a relevant clinical trial, leaving countless individuals unaware of potential breakthroughs that could transform their lives. Addressing accessibility and awareness gaps means ensuring every patient has the information and opportunities they deserve.

Studies consistently reveal pharmacists and nurse practitioners rank among the most trusted health professionals, making retail health clinics and pharmacies ideal platforms to bridge the gap and actively promote trial participation. By leveraging the trusted relationships built within these community healthcare settings, we have a unique opportunity to engage patients. We can redefine the narrative of trust in clinical trials to ensure that every patient feels supported, valued, and confident in their choice to contribute to scientific advancements.

The pandemic accentuated the importance of community healthcare sites, such as retail health clinics and pharmacies, as a place to receive preventive and clinical care. With more than 300 million COVID-19 vaccines given through these settings, pharmacies have emerged as a cornerstone of public health as well. This, coupled with the fact that 90% of the U.S. population lives within 5 miles of a pharmacy, community healthcare locations are primed to address accessibility issues plaguing clinical trial engagement and provide an equitable step forward.

With their trusted healthcare professionals and prominent retail locations, community healthcare sites are essential for establishing and expanding decentralized clinical trials. Moving forward, I believe they hold the key to tearing down barriers and unlocking widespread participation for a future where no patient is left behind in their quest for better treatments and improved outcomes.

Jim Kirby is chief commercial officer at Kroger Health.

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