2 Critiques of Federally Funded Medical Research: Not Enough Diversity, Not Enough Trials

Clinical trials financed by the federal government persistently lack racial diversity, and are now being squeezed out in importance by less-reliable corporate-sponsored alternatives, a pair of study teams reported on Tuesday.

One study, led by a group at the University of California at San Francisco and published in PLOS Medicine, found that the National Institutes of Health is failing to enforce its own requirements for racial diversity among clinical-trial patients.

It compiled NIH data on pulmonary research to show that the proportion of NIH-funded publications that reported racial or ethnic minorities among its participants had grown only slightly over 20 years, from around 2 percent in 1993 to around 5 percent in 2013.

The NIH requires diversity among study participants, but that requirement “is rarely enforced as a criterion for assigning priority scores for NIH grant applications,” said one author, Esteban G. Burchard, a professor of bioengineering at UC-San Francisco.

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NIH officials disputed both sets of conclusions. Agency officials said their record on racial diversity is improving among the studies in which minority participation is most important. {snip}

Among the most important NIH-financed trials–those in “Phase 3,” the final stage before regulatory approval–the enrollment of black participants increased from 10 percent to 23 percent from 2010 to 2014, said Michael S. Lauer, the NIH’s deputy director for extramural research.

And in some cases the numbers are even higher, Dr. Lauer said. He cited the recently completed Systolic Blood Pressure Intervention Trial, which began in 2009 with 9,300 participants. Some 30 percent were black, reflecting the greater risk that hypertension poses to the black population, Dr. Lauer said.

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