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.