Future of Clinical Trials
Nearly seven months ago, Walgreens launched its clinical trial business to redefine the patient experience in sponsor-led drug development research. As Walgreens prepares its first trials, our proactive and equitable patient-centric clinical research enterprise is supporting recent steps taken by the U.S. Food and Drug Administration (FDA) to increase opportunity, access and racial and ethnic diversity in clinical research, while also making it easier for sponsors to conduct their trials.
With Congress’ approval of the final fiscal year 2023 omnibus bill, I see a catalyst for widespread change into 2023 and beyond. The bill now requires sponsors to develop and implement diversity action plans, which must include the sponsor’s goals for enrollment in the clinical studies, their rationale for such goals, and an explanation of how the sponsor intends to meet the goals. Additionally, it establishes public workshops to enhance clinical study diversity and an annual summary report on progress towards this aim.
Today, Walgreens and other community pharmacies are in an optimal position to tackle barriers to diversity and inclusion. We plan to leverage our local presence, tech-enabled solutions and deep understanding of patients and communities to transform trials to meet the needs of our patients.
Our commitment to diversity runs deep
Today, approximately 20 percent of drugs have a variation in responses across ethnic groups, yet 75 percent of clinical trial participants are white, while only 11 percent are Hispanic and fewer than 10 percent are Black and Asian, according to recent FDA data.
The “Clinical Trial Diversity and Modernization” language in the spending package builds on the FDA’s recent draft guidance on this important facet of research as words are turned to action, ensuring the FDA can carry out its commitment to diversifying trials. Walgreens is committed to this vision of a more equitable future, working to eliminate long-standing challenges faced by patients and sponsors.
My team is taking bold, proactive and meaningful action as we work across the healthcare and life sciences industries to build a patient-centric, service-oriented business model. We are squarely focused on making clinical trials more accessible to our patients, particularly among underserved communities, so we can develop a more representative collection of trial data.
Bringing clinical trials into our communities
Finding solutions to clinical trial access challenges and other barriers to participation will require a rethinking of traditional frameworks. Grounded in our core purpose of creating more joyful lives through better health, we are committed to improving clinical trial diversity to bring the promise of life changing medications and medical products to more commnunities.
Big problems remain in clinical trials as certain populations, as defined by demographic factors such as race, ethnicity, sex, gender identity or age, have often been underrepresented in research. Their representation in clinical trials and studies needs to be a top priority. While COVID-19 magnified these healthcare inequities, it also highlighted the value of local pharmacies in providing high quality care for patients when they need it most.
Our goal is simple: We aim to boost patient enrollment, engagement and retention. Through our established pharmacy presence, robust digital engagement and synergies with AllianceRx Walgreens Pharmacy, CareCentrix and Shields Health Solutions, Walgreens has the potential to unlock flexible in-person, virtual and hybrid clinical trial models at scale. In addition to our physical footprint, Walgreens will deploy a compliant, validated, and secure decentralized clinical trial platform with the support of Principal Investigators and clinical research staff to facilitate clinical trials of all configurations.
We know active community engagement and education will be the doorway to improving access for patients who have traditionally been left out of the clinical trial domain. The key to increasing engagement is trust, one of our core values which our local pharmacists have established with their patients in communities across the country for over 120 years. Our individual relationships, in conjunction with our flexible set of digital and physical assets, will enable us to create a clinical trials experience that supports patient convenience.
We look forward to matching patients with trials quickly and efficiently, ensuring that traditionally underrepresented populations are now an equal part of the drug development process– and we are well on our way to that goal.
It’s time to talk less and do more. Let’s go!