Improving clinical trial access and engagement

By Troy Brennan, M.D., M.P.H., Executive Vice President and Chief Medical Officer

Whether it’s for widespread chronic conditions, rare diseases or — as we have seen over the past year — new threats to public health, the clinical trial process helps ensure that new health treatments work as expected and provide a marked improvement over existing treatments. The process also helps us learn of any risks they may pose to certain populations. Unfortunately, in the United States, low participation in clinical trials and systemic failings can lead to a less-than-optimal road for delivering critical treatments and therapies.

With the exception of the COVID-19 phenomenon, on average less than 5 percent of the U.S. population participates in a clinical trial year over year.2015-2016 Global Participation in Clinical Trials Report. U.S. Food & Drug Administration. https://www.fda.gov/files/drugs/published/2015---2016-Global-Clinical-Trials-Report.pdf That’s because the current clinical trial process in the United States is hampered by long-standing structural challenges. These include difficulty finding large, diverse groups of qualified individuals who can commit to months or even years of participating in a trial, lack of consumer access to local clinical trials, difficulty scaling programs, and unexpected delays in starting clinical trials. Together, these issues create a slow, inefficient system for delivering life-changing treatments to those who need them.

One of the biggest barriers to an effective, efficient clinical trial process is lack of access to diverse populations. The biopharma industry continues to struggle to engage racial and ethnic minorities, women and the elderly. This is particularly problematic because without appropriately diverse participant populations, the trial outcomes will not represent what would happen in the real world.

The good news is that CVS Health’s work in COVID-19 testing and vaccine distribution has provided a unique foundation upon which we can build a better clinical trial model.

The COVID-19 clinical trial challenge

The approval and deployment of three COVID-19 vaccines, with more awaiting approval, offers hope amid a pandemic that to date has resulted in the deaths of nearly 2.5 million people worldwide.COVID-19 Dashboard, February 2021. Johns Hopkins University. https://coronavirus.jhu.edu/map.html The vaccines also are a testament to the innovation of the companies that developed them and their ability to get the right data, the right participants, and the right protocols to move clinical trials forward in record time.

CVS Health also innovated to meet the incredible public health challenges of COVID-19. At the start of the pandemic, we quickly established testing services through community centers, retail drive-thru, stand-alone and employer locations by building on our existing infrastructure to reach Americans across nearly every demographic. With more than 15 million tests administered to date, we’ve gained unique insights and an opportunity to support the biopharma industry and institutions in their efforts to find new COVID-19 vaccines, treatments or therapies.

The challenge is finding large volumes of diverse, COVID-positive and -negative patients who meet stringent clinical trial criteria and will participate. Utilizing our testing infrastructure, CVS Health is playing a new role by helping to identify, engage and recruit appropriate candidates for investigative vaccine and treatment trials.

Since June 2020, CVS Health has worked with five of the Operation Warp Speed clinical trial sponsors and other critical industry partners to find potential COVID-19 trial participants, successfully engaging more than 300,000 pre-screened volunteers. In a recent study requiring a large volume of COVID-19 positive patients within five days of their swab test, we effectively engaged approximately 4,000 interested, qualified individuals per week. Diverse candidates made up almost half of the interested population, unprecedented in the world of clinical trials. And all participants live within proximity to a study site, making it easier for them to stay in the trial.

What’s next

The COVID-19 pandemic has allowed us to achieve impressive new levels of scientific innovation and establish novel public-private partnerships. We believe we can build upon these new relationships and capabilities to improve the effectiveness of clinical trials and advance health care.

At CVS Health, our focus is on the communities that we serve. As such, we will continue to increase access to clinical trials for all communities and work with key biopharma partners to make the process more efficient. We believe this effort will improve outcomes and allow us to continue to innovate to improve health care.