WASHINGTON — Clinical trials that the National Institutes of Health funds often enroll fewer Black patients and other underrepresented racial groups than they plan to, according to a study of 30 NIH-funded trials sampled by the HHS Office of Inspector General.
Policymakers want to get researchers to enroll a racially representative sample of patients in clinical trials that test whether products work and are safe. But researchers often fail to do so.
The OIG findings are in line with other studies from outside the government, according to William Fitzsimmons, a founder of the CARER Group, which is pushing to improve trial diversity. However, those studies looked at clinical trials funded by drug and medical device companies.
“One would assume that the academic NIH studies may perform better on diversity, but that doesn’t appear to be the case,” Fitzsimmons said.
When researchers apply for NIH funding, they must explain how they plan to enroll patients who are representative of the population that would be affected by the condition for which treatments are being studied. These “inclusion plans” must include a numerical breakdown of targeted participant demographics by race, ethnicity, and gender.
Most NIH-funded clinical trials that OIG reviewed missed planned enrollment targets. Some trials missed enrollment targets by a little, some by a lot. Clinical trials most commonly recruited fewer Black, American Indian and Alaska Native, and Asian participants than originally planned. Clinical trials missed targets for female participants more often than they did for male participants.
About half of clinical trials were missing information required to explain the goals for the racial and gender makeup of clinical trials.
“These shortfalls we saw in our review of inclusion plans raise concerns about NIH’s peer review process and the extent to which this section of the grant application is thoroughly analyzed,” the OIG said.
However, some trials surpassed their diversity enrollment goals for certain racial groups. For Native Hawaiian and Pacific Islander participants, clinical trials met or exceeded enrollment targets as often as they missed them. Clinical trials met or exceeded enrollment targets for Hispanic and Latino participants more often than they missed them.
Congress in late 2022 passed a law requiring companies to give the Food and Drug Administration their plans for diversifying clinical trials. The agency is five months late providing the industry with guidance on how to do that, but an agency official said to expect it very soon.