National retail pharmacy chains are increasingly engaging in decentralized clinical trials, seeking to improve patient recruitment and diversify study populations. This trend, accelerated by the COVID-19 pandemic and supported by the FDA, positions pharmacies as key intermediaries between pharmaceutical companies and potential trial participants.
Pharmacies Step into Clinical Trial Recruitment
Retail giants such as Walgreens, Walmart, and Kroger have established clinical trial divisions, aiming to make trials more accessible and convenient for customers. This move addresses a significant challenge in drug development: low clinical trial enrollment. According to the Journal of Medical Internet Research, approximately 80% of trials fail to meet their initial enrollment targets, leading to substantial financial losses for drug developing companies, potentially reaching US $8 million per day.
Ramita Tandon, Chief Clinical Trials Officer at Walgreens, noted the convenience factor, stating, "If you see the trial is at an academic institution that’s 30, 40 miles away, you’re going to say, ‘Forget it. It’s too far.’ But if you can go to a Walgreens that’s maybe five miles away, you’re more likely to participate and complete the trial."
Focus on Diversity and Inclusion
Another critical goal is to enhance the diversity of clinical trial participants. Biopharmaceutical companies like Pfizer and Gilead are actively seeking to broaden their patient pools. FDA data from 2022 indicates that White individuals comprised the majority of patients in pivotal trials for novel therapies, followed by Asians and Blacks. Pharmacies, with their extensive reach into diverse communities, are well-positioned to address this disparity.
Walgreens, operating nearly 9,000 pharmacies across the US, has already contacted over two million customers about potential clinical trial participation. Walmart, with over 3,000 pharmacies and a presence within ten miles of 90% of Americans, launched the Walmart Healthcare Research Institute (WHRI) to focus on underserved communities, including older adults, rural residents, women, and minority populations.
Market Growth and Competition
The clinical trials market is experiencing significant growth, projected to reach over $83 billion by 2032, according to Precedence Research. This expansion has attracted major players in the retail pharmacy sector. However, not all ventures have been successful. CVS Health, the first pharmacy to launch a clinical trials program in 2021, is discontinuing its unit by the end of 2024, citing strategic alignment issues.
Steve Wimmer, Vice President of Partnerships at 1nHealth, suggested that fully decentralized models may face challenges due to safety and regulatory concerns. He noted the difficulty in standardizing such trials, highlighting the difference between clinical study visits and primary care visits.
Potential Impact on Clinical Laboratories
The involvement of retail pharmacies in clinical trial recruitment could impact traditional clinical laboratories and pathology groups, which have historically played a role in connecting patients with trials. While pharmacy-led recruitment programs may reduce revenue for these labs, the increased participation and diversity in clinical trials could ultimately accelerate the development of new treatments and therapies.
