Local pharmacies and big-box stores are no longer just purveyors of deodorant, prescriptions and laundry detergent; many have crossed the line into healthcare providers — offering everything from flu vaccines to primary care checkups. These highly trafficked neighborhood retailers have been building healthcare delivery capabilities at more than 2,000 locations nationwide, aligning to changing patient preferences and answering the call of consumers who want care at more convenient locations.
This shift for retailers and the disruption to conducting clinical trials at academic medical centers and hospitals by COVID-19 has given the biopharma industry an opportunity to significantly accelerate alternative clinical trial delivery approaches, such as local, at home and virtual options. Leveraging the scale, reach and capabilities of national retail health clinics and physician practices is helping to transform an antiquated clinical trial model and address the weaknesses of traditional trials that were exposed by shutdowns during the pandemic.
Decentralized trials — which are designed, planned and executed using a combination of delivery channels — are seen as a way to reduce operational complexities, cycle times, costs and patient burden. In addition, decentralized trials can open access to more diverse patient populations, bolstering enrollment and offering increased flexibility that reduces patient burden and improves retention.
For instance, pharma companies open an average of 94 sites per Phase III trial, according to Citeline1. Traditionally, clinical trials take place across a large number of small, fragmented sites, making it difficult to effectively plan, deliver and manage clinical trials. Alternatively, new entrants could offer a large number of locations that are operated as a single megasite, providing companies with large national partners that are convenient to patients. The future model could bring the total number of sites down from the current average of 94 to as few as 10 on a typical Phase III trial, providing a hub-and-spoke model with better geographic coverage, as well as enterprise-level compliance and quality monitoring.
New entrants — like national retail pharmacies, retail health clinics, physician practices and decentralized trial technology companies — have access to exponentially larger numbers of patients. PwC’s Health Research Institute found that 67% of consumers were less likely to participate in a clinical trial for COVID-19 treatment if they had to travel outside of their local area to a trial site.
Increased access to patients allows for the acceleration of recruitment and the ability to start up fully-scaled trial delivery capacity in days or weeks versus months. The convenience of location and increased access improves flexibility for patients, ultimately reducing the patient dropout rate.
1 source: TrialTrove, citeline.informa.com, accessed October, 2021
50% of FDA clinical trials in the US are conducted in only 1-2% of zip codes
National retail health clinics and community practices such as CVS HealthHUB, Walmart Care Clinic and Kroger’s The Little Clinic are likely players whose existing infrastructure could be leveraged to play a critical role in the next-generation clinical development models currently being established. These large players will catalyze a decentralized, “omnichannel” approach that integrates hospitals, at-home services, virtual/technology aspects and local providers and clinics.
These new entrants are rapidly expanding their healthcare service capabilities and capacity. For instance, CVS has begun to convert retail locations into HealthHUB formats that include a broad range of healthcare services. CVS, which has the largest retail clinic presence in the US, plans to operate 1,500 HealthHUBs by the end of 2021. CVS fills or manages 2.5 billion prescriptions.
Meanwhile, Walmart, which has around 265 million weekly shoppers globally, launched its first clinic in 2019 providing primary medical services, dental care, vision care and behavioral health services, alongside health education and wellness programs. The retailer has opened 20 standalone healthcare centers with plans to open 15 more in 2021, part of a strategy to open 4,000 clinics by 2029.
Not to be left behind, Walgreens has partnered with VillageMD to open 500 to 700 doctors’ offices in stores, while Kroger operates approximately 215 Little Clinics in its grocery stores.
We believe these local healthcare facilities will play a major role in the transformation of R&D. Retail clinics and community practices have the capabilities to support trials in far more disease areas than virtual approaches alone.
Retail health clinics are generally located closer to participants’ homes and places of work than large clinical trial sites, affording patients the flexibility to tailor their trial experience to their needs and preferences. A survey2 reported that 80% of patients said they would join clinical trials if the site was 30 minutes or less from home.
Furthermore, national retail pharmacies and retail health clinics/physician practices have far more opportunities to engage with potential trial participants and access to additional data that could inform targeted recruitment efforts.
2 source: The Washington State Office of Financial Management, accessed October, 2021
Retail clinics and community practices have the capabilities to support trials in far more disease areas than virtual approaches alone.
The industry has been experimenting with innovative ways to deliver clinical trials for years, but has failed to make decentralized trials the industry norm, most previous efforts did not progress beyond experimentation and piloting. COVID-19 has been the catalyst that pushed the industry to innovate.
In some instances, pharma companies have not gone far enough, relying on models that weren’t applicable across a diverse set of therapeutic areas and didn’t fully address patient needs. Home-based care models are often considered too invasive by patients who oppose bringing medical care providers into their homes. Meanwhile, virtual care has been adopted at some level across the industry, but not in the form of fully virtualized trials, which come up against everything from technology challenges to limited feasibility for certain therapeutic areas to a lack of medical staff in the event of an emergency.
Yet shifts to the greater landscape, largely driven by disruptions to care during the height of the pandemic, could help decentralized trials become more mainstream. Further evidence that this model is likely to become more entrenched:
PwC has been supporting the bleeding edge of clinical development operations for over a decade across operating model design, CRO strategy, advanced analytics, and decentralized trials. The R&D practice has led the development of innovative decentralized trial market offerings as well as supported sponsors in evaluating strategic fit for their portfolios. For this, PwC has developed a proprietary capability that uses analytics and natural language processing (NLP) to assess endpoints and to identify the optimal assets and disease areas for decentralization. In addition, PwC has developed a deep understanding of the ancillary impacts of decentralized trials (data aggregation/integration, trial and multi-provider oversight powered by data automation and AI, etc.) that require infrastructure to support a compliant and safe trial execution strategy.
With this experience coupled with the PwC’s technology enabled service offering, we can expedite the process of developing a new product market opportunity or evaluate decentralized clinical trials as an opportunity for sponsors seeking entry into the decentralized trial space.