Walgreens is expanding its clinical trial business, prioritizing patient access and representation to redefine the patient experience. Launched in June 2022, Walgreens' clinical trial business utilizes its extensive retail pharmacy footprint to offer patient recruitment, trial conduct, and real-world evidence services to biopharma sponsors.
Addressing Patient Access and Representation
Ramita Tandon, Walgreens' Chief Clinical Trial Officer, emphasized the company's focus on tackling issues related to patient access and representation in drug development. "Our focus has been just, how do we get access to patients faster? How do we improve the representation in the drug development process?" she stated. Walgreens aims to include communities historically underrepresented in research, ensuring a more diverse participant pool.
Three Key Service Offerings
Walgreens' business model is structured around three core service offerings:
- Insights-Driven Patient Recruitment: Utilizing direct patient access to 100 million lives, Walgreens indexes patients by race, gender, ethnicity, social determinants of health, and zip code. As a covered entity, Walgreens can directly outreach to patients, using culturally relevant modalities to increase participation.
- Trial Conduct: Walgreens offers flexible trial conduct options, including in-store locations with private health rooms, hybrid models combining in-store and digital components, and at-home services with nurses and telehealth oversight. This flexibility addresses accessibility issues for patients unable to reach traditional medical centers.
- Real-World Evidence Informatics: Tapping into consumer and patient information, Walgreens supports pharma partners in evidence generation planning, retrospective analyses, and prospective data collection for post-market studies and safety surveillance programs.
Therapeutic Areas and the Role of Pharmacists
Walgreens supports a wide variety of therapeutic areas, including diagnostic and screening for lung cancer and colon cancer (enrolling up to 50,000 patients), diabetes, cardiovascular outcomes, heart disease trials, and vaccination programs. The company also leverages its specialty pharmacies to support trials for specialty conditions.
Pharmacists play a crucial role in driving awareness and education about clinical trials. Walgreens is intentional about staffing clinical trials with experts from pharma, CROs, and SMOs to ensure compliance and avoid undue burden on pharmacists. A national clinical trials training program is also in place to allow pharmacists to advance their careers in clinical research.
Strategic Partnerships and Decentralized Clinical Trials
Walgreens has formed strategic partnerships, including one with BARDA, to drive innovation in decentralized clinical trials. Decentralization involves bringing clinical trials closer to patients through alternative sites of care, digital modalities, and at-home services. A recent partnership with Boehringer Ingelheim focuses on a Phase 3 study in obesity and diabetes, specifically targeting recruitment of Black and Hispanic patient populations.
Market Opportunity and Future Outlook
The outsourced R&D services market is experiencing healthy growth, with an 18% increase reported by IQVIA in 2023. With overall R&D investments around $150 billion, and 50% spent on outsourced services, Walgreens sees tremendous growth potential in supporting pharma and capturing these services. The company envisions a future where the role of pharmacy and pharmacists is essential in healthcare, leveraging trust, scale, and accessibility to drive momentum in clinical research and improve patient outcomes.
