While the pharma industry regularly touts the importance of diversity in clinical trials, some research is falling short.
Many trials aren’t hitting diversity goals and may in fact be severely underperforming, according to a recent report from the Office of Inspector General that examined enrollment in a random sample of 30 phase 3 trials funded by the National Institutes of Health, the largest federal funder of clinical trials in the U.S.
Of the sample, only two-thirds had inclusive enrollment plans, while the rest didn’t have any plans to boost inclusion of all racial and ethnic groups. Even among trials with a strategy in place, most “missed planned enrollment targets for underrepresented groups,” the report found.
Not only did many trials fail to meet diversity goals, “slightly more than half” examined by OIG were missing required information on how they determined enrollment targets.
Missing the mark
The OIG looked at inclusion enrollment data from 30 trials that were underway between 2016 to 2020. The NIH require clinical trial researchers to submit inclusion enrollment plans for their studies, and 10 trials in the review were missing at least one group, but were approved anyway. Most often left out were Native Hawaiian or other Pacific Islanders.
The report also zeroed in on whether or not researchers had “robust rationales” for inclusion plans that were “grounded in science” — a key to actually hitting enrollment targets.
Within the sample, 17 trials included little or no rationale for how they chose their enrollment targets, and in one case, a researcher “guessed” what the study’s final enrollment numbers would be, according to the report.
Thirteen of the trials had robust rationales for their enrollment targets, with analysis of disease burden and demographic data. And many of these trials had previous clinical trial network recruitment for reference.
Although the OIG found that the majority of trials didn’t succeed at hitting diversity goals, many came close. Some trials only missed their target by 15% or less, including one that aimed to enroll 75 Asian Americans but only enrolled 68.
Others, however, faced more significant misses, including one that had a goal of enrolling 144 Black Americans and ended up with 74.
The industry push
Because the OIG’s review only focused on NIH-funded studies, the results don’t necessarily reflect other efforts to improve clinical trial diversity. In the past few years, the industry has placed more urgency on the issues, especially following the COVID-19 pandemic, which shined a light on health disparities as minority populations faced higher rates of infection and death. Still, Black, Hispanic and other minority groups were underrepresented in clinical trials for COVID-19 vaccines, according to Kaiser Family Foundation analysis in 2021.
More pharma companies are making diversity a prominent part of their clinical trial design, such as Takeda’s attempt to achieve “unprecedented patient diversity” in its phase 3 trials for a key psoriasis candidate or J&J’s inclusivity plan to de-gender clinical trials. Plus, more pharma and biotech companies have hired chief diversity officers who are not only leading internal charges to tackle diversity in leadership across organizations, but external efforts toward clinical trials.
Despite this push, some progress has been elusive. Studies consistently show that women are still underrepresented in trials, potentially due to their design, for example.
NIH efforts
According to the OIG, underrepresentation makes it more challenging to extrapolate results across populations.
“Not meeting enrollment targets, as well as not committing to include certain groups in inclusion enrollment plans, risks fewer members of underrepresented groups participating in NIH-funded research,” the report noted. “This may result in research that does not accurately reflect either disease burdens or the general population, making it difficult to produce generalizable results.”
NIH program officers said diverse recruitment is a priority, but researchers often struggle with competing goals for each trial, and report challenges in recruiting specific patient populations and underrepresented groups. The NIH have an agency-wide diversity plan — the Strategic Plan for Diversity, Equity, Inclusion and Accessibility — that supports research benefiting all groups and specifically those that have been historically underrepresented.
NIH program officers attempt to intervene when trial enrollment is lagging behind diversity goals, catching underperformance early for a chance to address the problem, the report noted.
Even when under-enrollment is flagged, there’s typically little success in moving the dial, the OIG reported. The NIH may give extensions for recruitment, allowing researchers to adjust the number of patients in trials or even change the study design, but these added flexibilities may still fall short.
The OIG recommended the NIH firm up the requirement that each study plan “fully describes the basis for its planned study population” and hold researchers accountable for their recruitment goals by requiring transparency.
