In December, Congress enacted new requirements that require drug- and device-makers to ensure there is sufficient diversity in their clinical trials. Yet lawmakers and advocates don’t want to stop there.
Among them is Democratic Rep. Robin Kelly, who plans to reintroduce a bill this month that would require sponsors of research, funded by the National Institutes of Health, to lay out recruitment goals that reflect the race, ethnicity, age, and sex of patients who have the condition being studied or that reflect the general population of the United States. Republican Rep. Brian Fitzpatrick cosponsored the measure. Republican Sen. Susan Collins and Democratic Sen. Bob Menendez sponsored a companion bill in the Senate.
“Racial and ethnic minorities are not properly represented in clinical research. That’s the bottom line,” Kelly told National Journal.
The proposal aligns with a measure enacted as part of the massive government-funding bill passed at the end of December. That provision requires drug and device sponsors to submit diversity action plans to the Food and Drug Administration. The agency also is required to develop new guidelines or update already existing guidance for these plans.
Kelly said her focus on NIH clinical trials can complement the FDA measures, because there are “things that NIH will capture that FDA won’t.”
“It’s important, because NIH tends to fund earlier phases of clinical trials and research, things like behavioral-health intervention, that will not be subject to FDA’s new clinical-trial diversity,” she continued.