No one would disagree that diversity in clinical trials is critical. Diversity ensures that novel drugs will be effective and safe for all patients. But, a new FDA report shows that clinical trials may not reflect real-world demographics. And these trials may not be diverse enough to ensure patient safety.
For instance, the latest report shows only 48% of drug testing populations consisted of women. Only 7% were African Americans while 76% were white. Participants over the age of 65 only accounted for 21% and just 11% were Asians.
These are not surprising statistics for a couple reasons:
- Until the late 1980s, clinical trial participants were predominantly men.
- Today, participation in trials does not seem to resonate with many patients.
A 2016 survey by Memorial Sloan Kettering Cancer Center showed only 35% of patients (of any background) said they were likely to enroll in a clinical trial. Only 40 percent of survey participants had a favorable view of clinical trials. While 28% of physicians viewed clinical trials as a last resort.
The FDA has and continues to put forth the effort to balance out diversity. However, it is an uphill battle and progress is slow. The percent of women in clinical trial participants has increased by only 8% from 2015 to 2016. And the percent of African American participants rose only 2% during that same period.
This imbalance is also of concern to many drug companies. Ely Lilly has a section on their website devoted to this. It states: “it’s critical for Lilly to have diverse representation in clinical trials—to gain the insights necessary to make medicines that will be the most effective for all people who use them.”
If this issue is so important to both the FDA and pharma, why does this diversity imbalance continue? Can effective patient engagement be a solution?
With the FDA pushing for more real-world data inclusion in clinical trials, and challenges in recruitment, it’s puzzling why the industry is not pursuing greater diversity in clinical trials. Myths and misconceptions about clinical trials are still widespread. These are highlighted in this terrific article from Dana Farber Cancer Institute.
All parties would be well served to dispel these misunderstandings and recognize the value of clinical trials for patient health and for the advancement of science. More companies should follow Eli Lilly’s lead and explore more diverse patient populations. They may find patient engagement diversity develops into a competitive advantage.