Bad Science: When Clinical Trial Volunteers All Look Alike

The more we understand that individuals can respond differently to the same medical treatment, the more we realize that you can’t draw sweeping conclusions from clinical studies that don’t include a broad swath of people. So why has the FDA been so slow to beef up the diversity of subjects who participate in clinical trials?

A couple of months ago, the FDA introduced a plan to improve the collection of data and the analysis of it for groups that typically have been underrepresented in research studies – chiefly, women and minority groups. As reported on MedPage Today.com, the effort is supposed to:

  • compile better-quality subgroup (gender, ethnicity, etc.) data;
  • identify barriers that keep women and minorities from participating in trials;
  • figure out ways to recruit more of them;
  • make subgroup data more available and transparent.

In terms of transparency, the FDA’s plan not only is to post relevant subgroup information from significant trials, but to make sure that relevant demographic information is included on product labeling.

The medical community’s response to the action plan generally was positive. Several organizations, including the American Heart Association, the National Women’s Health Network and the Society for Women’s Health Research, issued a news release that the plan “will not only help boost representation of these population groups in clinical trials, but also will lead to more analyses on how medical drugs and devices affect women and men differently.”

But they also found the FDA effort wanting. “[T]he agency must do more than remind and encourage industry to include women and minorities in trials and analyze the data. The FDA must require that companies do this to ensure that that the products women use are safe and effective for them.”

Diana Zuckerman is president of the National Center for Health Research, which promotes the health and safety of women, children and families through objective, research-based information to develop effective programs and policies. She applauded the FDA’s initiative, but thought it was a bit wimpy.

“As long as the FDA is going to approve these products for everyone, when they haven’t been studied on everyone, then the [pharmaceutical] companies really have no incentive to improve,” she told MedPage Today.

In other words, the feds need to get tough with the industry that makes so much money marketing drugs and medical devices to everybody, often without considering the effects of their products on people beyond the homogenous group of subjects that tested them.

For example, Zuckerman thinks the agency should tell the drug companies that if their clinical trial for a particular drug doesn’t have enough women in it for a subgroup analysis, then the FDA won’t approve it for marketing to women. Ditto if they didn’t have enough African Americans or Latinos in the trial.

“Pretty soon drugs will be approved for 30% of the population,” she pointed out. “…The FDA has the authority and responsibility to not approve drugs or devices that are not tested on the largest demographic groups.”

The FDA’s plan doesn’t mention pregnant women, nor children, which are two large groups that need attention in new drug and device trials, but whom are hard to study for ethical reasons.

We’ve blogged about the need for drugs that are prescribed for children to be studied in that population, not just with adult trial subjects, because children aren’t just miniature grown-ups. Their immature bodies don’t always process pharmaceuticals the same way an adult body does.

Two recent laws recognize the wisdom of separating out kids for clinical testing, the Best Pharmaceuticals for Children Act (BPCA), which offers drug companies six months more of marketing exclusivity if they conduct FDA-requested pediatric studies, and the Pediatric Research Equity Act (PREA), which requires some drugs developed for adults to be studied in children.

But it’s only a start, an evolutionary effort. And evolution, as everybody knows, takes a long time. The government should do all it can to move the process along.

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