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The pharmaceutical industry regularly The Importance of Diversity in Clinical TrialsSome studies are lacking.
Many tests are Achieving diversity goals And, in fact, 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: Largest Federal Funder Clinical Trials in the United States
Only two-thirds of the trials in the sample had a comprehensive enrollment plan, and the remaining trials had no plans to be inclusive of all racial or ethnic groups. Even among trials with a strategy in place, most “failed to meet enrollment goals for underrepresented groups,” the report found.
Not only did many trials fail to meet their diversity goals, but “just over half” of the trials OIG investigated lacked required information about how they determined their enrollment goals.
Missed the mark
The OIG looked at enrollment data for 30 trials conducted between 2016 and 2020. NIH requires clinical trial researchers to submit enrollment protocols for their studies, and 10 of the trials reviewed were missing at least one group but were still approved, the most commonly missing being Native Hawaiians and other Pacific Islanders.
The report also focuses on whether researchers have a “robust evidence base” for a comprehensive plan that is “science-based,” which is key to actually achieving enrollment goals.
The report found that 17 trials in the sample provided little or no justification for how they selected participants, and in one study researchers had “guessed” how many people the study would ultimately enroll.
Thirteen trials had a strong rationale for enrolment targets through analysis of disease burden and demographic data, and many of these trials had previous clinical trial network recruitment as reference.
The OIG found that while the majority of trials did not meet their diversity goals, many came close. Some trials met their targets by 15% or less, including one trial that aimed to enroll 75 Asian American students but only enrolled 68.
However, some schools fell far short of their targets, such as one that set a goal of enrolling 144 black Americans but ultimately enrolled only 74.
Industry Promotion
The OIG investigation focused only on NIH-funded studies, so the results don’t necessarily reflect other efforts to improve diversity in clinical trials. The pharmaceutical industry has taken the issue to greater urgency in recent years, especially since the COVID-19 pandemic, when higher infection and death rates among minorities have highlighted health disparities. Still, Blacks, Hispanics and other minorities are underrepresented in the U.S. and Canada. Underestimated in clinical trials Demand for COVID-19 vaccines remains high, according to a 2021 analysis from the Kaiser Family Foundation.
More pharmaceutical companies are making diversity a key part of their clinical trial design. Takeda’s Attempt Achieving “unprecedented patient diversity” in Phase 3 trial of potential psoriasis drug, or J&J’s inclusiveness Plans to eliminate gender in clinical trialsIn addition, more pharmaceutical and biotechnology companies Hiring a Chief Diversity Officer She leads internal efforts to address leadership diversity across the organization as well as external efforts toward clinical trials.
Despite these efforts, progress has been slow. Research has consistently shown that Women are still undervalued For example, it may fail the test due to design reasons.
NIH Initiatives
According to the OIG, less representativeness makes it more difficult to extrapolate results across the population.
“Failing to meet enrollment targets and/or commit to including certain groups in comprehensive enrollment plans risks underrepresented members of these groups participating in NIH-funded research,” the report states. “The result may be studies that do not accurately reflect either the disease burden or the general population, making it difficult to produce generalizable results.”
Program officials at the NIH said diverse recruitment is a priority, but investigators report that trials often have competing goals and that there are challenges in recruiting specific patient populations and underrepresented groups. The NIH has an institution-wide diversity plan. Diversity, Equity, Inclusion and Accessibility Strategic Plan — Support research that benefits all groups, especially groups that have been historically underrepresented.
NIH program officials are stepping in when trial participation lags behind diversity goals, the report said, to catch poor performance early and seize the opportunity to address the problem.
Even when under-enrollment is flagged, OIG reports, it typically does little to change the situation: The NIH might extend enrollment periods to allow researchers to adjust the number of patients in a trial or change the study design, but even this increased flexibility is sometimes not enough.
The OIG recommended that NIH strengthen the requirement that each research protocol “fully describe the basis of the proposed study population” and hold researchers accountable for their recruitment goals by requiring transparency.
