America is a diverse country. The same can't be said of the studies used to determine what medicines American doctors should utilize to fight heart disease, cancer, and other illnesses.
In 1993, Congress passed the National Institutes of Health Revitalization Act, which requires the NIH to recruit women and minorities for drug studies. Basically, taxpayer-funded clinical trials—the final studies that prescription treatments must undergo before they're able to get approval from the Food and Drug Administration—are supposed to be diverse. More than 20 years later, however, it appears the NIH is only partway there, a team of American and Spanish researchers argue in a new paper in the journal PLoS Medicine.
In their paper, the researchers offer policy suggestions for how to speed up the process of making American clinical trials truly representative of the population. Most of the suggested fixes would apply to the NIH. After all, the problem likely lies with recruiters, not study volunteers. Surveys show that, although some Americans of color have mixed feelings about biomedical research, others say they're willing to participate.
How white men react to an experimental drug doesn't always reflect how all people will react.
The paper also collects some of the latest research showing disparities in who's recruited for clinical trials. There's this review, which found less than two percent of the trials sponsored by the National Cancer Institute focus on treatments' effects on minorities. Then there's this review of NIH-funded studies about lung diseases, which shows that fewer than five percent of such studies say whether their volunteers include minorities.
Why does it matter if clinical trial volunteers tend mostly to be white men? How white men react to an experimental drug doesn't always reflect how all people will react. Of course, not everybody of a certain race will all respond the same way to a drug. Race is a cultural category, and many factors impact how well treatments work for people. Still, those of the same race are often more likely to have certain genes that affect how they metabolize drugs. Plus, they may be under similar social pressures, which affects their health and how they respond to treatments. The more a clinical trial's volunteers reflect Americans of all backgrounds, the more likely the results of the trial will actually be indicative of the drug's effects on the free market.
Last year, the NIH created some radical new policies to include more female lab animals in studies of drugs not yet ready for humans. The researchers advocate that the institutes try something similar to force the inclusion of minorities in clinical trials. In addition, how much funding studies get could be tied to whether they include diverse study volunteers, the authors argue. "We believe this would prompt researchers of all racial/ethnic and cultural backgrounds to incorporate understudied populations in their research studies," they write.
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