Addressing Shortcomings in Research: Walgreens Launches Clinical Trial Business

The United States has a long-storied record of clinical research and innovation. Clinical research has improved the treatment and prevention of disease across the population, when implemented universally.

These efforts come with a large investment. In 2020, phase 1, 2, and 3 clinical trials spanning all therapeutic areas cost approximately $4 million, $13 million, and $20 million, respectively.¹ The 2020 global clinical trials market size is $48.4 billion and is projected to be worth around $84.43 billion by 2030.²

One of the most critical issues in clinical research has been the lack of representation across studies. In many clinical trials, older adults, those pregnant and lactating, and persons with disabilities have been underrepresented or excluded. Thus, diversity in clinical trials has become an important goal across many federal government agencies.⁴

The lack of diversity contributes to several important shortcomings.⁴ These include the inability to apply clinical trial results to the whole US population, costing the United States billions of dollars in potential savings. Innovation that could lead to new discoveries is hindered. Lack of access to important medical interventions may ensue. Low enrollment accrual, which causes trials to fail, could be avoided by greater diversity of recruitment. And perhaps most importantly, lack of representation continues the pattern of distrust of health care by underrepresented populations.

To address the recruitment disparity in clinical trials, Walgreens has launched a business focusing on increasing access and retention of participants in clinical trials.³ Walgreens has a large footprint around the United States, importantly including socially vulnerable areas where underrepresented persons live and frequent. The fact that many persons look favorably at community pharmacies for health information and products will assist trust towards the potential recruitment of underrepresented persons.

Furthermore, Walgreens will use their extensive patient database to link patient-authorized data to clinical trials across a wide range of diseases and disorders. Walgreens states they have developed a compliant, validated, and secure decentralized clinical trial platform to ensure patient privacy and security.

Finally, their third strategy is to use their real-world evidence to bring innovation to the field of clinical research.   

Time will tell whether Walgreens’s strategy benefits recruitment. What does NOT appear to be included in their model is the research question development, project funding, methodological design and regulatory approval, where and how the informed consent processes will take place, patient remuneration, and multilingual connection to the potential research participants.

Will genetics and especially pharmacogenomics be incorporated into research design given that pharmacy is an active participant? Will clinical research activities take place at Walgreens pharmacy settings? This may be problematic based on the travel needs of participants. Will pharmacy personnel be trained in management of clinical trials? These are some important questions as this enterprise moves forward.

Another important question will be the tools Walgreens uses to recruit potential participants. A recent study sheds light on whether using traditional racial categorization is the proper way to recruit clinical trial participants. The medical literature is replete with differences in disease burden and health outcomes based on race and ethnicity.⁵ Using strict race and ethnicity data reflects an incomplete understanding of underrepresented persons.

Social determinants of health may be a better inclusion criterion for recruitment. A retrospective study of data from the Get With the Guidelines Heart Failure Registry identified heart failure hospitalizations from January 2010 through December 2020 to validate a machine learning model for heart failure mortality that incorporated social determinants of health.⁶

The machine learning model demonstrated superior performance to traditional logistic regression models that used race as a covariate. The addition of social determinants of health improved the prognostic utility of prediction models for Black patients, but not for non-Black patients. Models that will be used to recruit underrepresented populations will need to be continually updated and applied to the Walgreens clinical trial business. 

The US health care community and the profession of pharmacy are excited about the entry of community pharmacy into the clinical trial business. We will be watching closely to determine whether this type of business model can adequately recruit and safely deliver on the promise to improve clinical trials.

References:

1. Ledesma P. How much does a clinical trial cost? Sofpromed. January 2, 2020. Accessed August 1, 2022. https://www.sofpromed.com/how-much-does-a-clinical-trial-cost
2. New research emerges to challenge steep costs of clinical trials. Applied Clinical Trials. July 6, 2020. Accessed August 1, 2022. https://www.appliedclinicaltrialsonline.com/view/new-research-emerges-challenge-steep-costs-clinical-trials
3. Levy S. Walgreens launches clinical trial business. Drug Store News. June 16, 2022. Accessed August 1, 2022. https://drugstorenews.com/walgreens-launches-clinical-trial-business 
4. National Academies of Sciences, Engineering, and Medicine. Improving Representation in Clinical Trials and Research: Building Research Equity for Women and Underrepresented Groups. The National Academies Press; 2022. doi:10.17226/26479
5. Yancy CW, Khan SS. Replacing race with social determinants of health in risk prediction—getting it right. JAMA Cardiol. Published online July 6, 2022. doi:10.1001/jamacardio.2022.1909 
6. Segar MW, Hall JL, Jhund PS, et al. Maching learning-based models incorporating social determinants of health vs traditional models for predicting in-hospital mortality in patients with heart failure. JAMA Cardiol. Published online July 6, 2022 doi:10.1001/jamacardio.2022.1900