WASHINGTON -- The FDA is trying to increase representation of women and minorities in clinical trials, but observers said the agency's latest effort in this area is not sufficient.

The FDA announced last week that it had developed an action plan to improve data collection and subgroup data analysis for women and minorities in clinical trials. The action plan addresses three issues: getting better-quality subgroup data, identifying barriers to encourage women and minorities from participating in trials and figuring out strategies for recruiting more of them, and making subgroup data more available and transparent.

The agency also issued a final guidance explaining how data on gender differences should be analyzed in medical device studies to account for the fact that the sexes each respond differently to devices.

"I hope you'll find that the action plan is responsive and pragmatic and, most importantly, when fully implemented, it will improve medical care and public health," FDA Commissioner Margaret Hamburg, MD, wrote in a blog posted on the agency's website.

"Many of the steps it outlines will have a broad impact on the work of FDA's medical product centers ... The action items range from relatively short-term goals that can be achieved in a year, to others that will take 1-3 years, to a small number that will require a longer period, 3-5 years, to achieve."

To improve the quality of subgroup data, the action plan directed the agency to:

Review and develop a work plan for updating, and/or finalizing, relevant guidance on demographic subgroup data, including FDA staff training and outreach to stakeholders

Work with sponsors to revise medical product applications to enhance information on demographic subgroups in medical product applications

Add training for FDA reviewers around demographic inclusion, analysis, and communication of clinical data

Enhance FDA's systems for collecting, analyzing, and communicating diverse clinical information to optimize safe and effective use of medical products in diverse populations

Conduct research on specific areas of public health concern related to demographic subgroups

To help identify barriers to recruiting women and minorities, the plan called for:

Seeking further clarity about barriers to subgroup participation rates

Implementing efforts to enhance appropriate use of enrollment criteria in clinical trial protocols

Collaborating with the National Institutes of Health, industry, and other stakeholders to broaden diverse participation in clinical research

Using FDA's communication channels to encourage clinical trial participation by demographic subgroups

On the third goal of making the data more transparent, the plan called for FDA to post relevant subgroup information from pivotal trials, identify ways to include demographic information on product labeling, and communicating the subgroup information with an eye toward language access and health literacy for the involved populations. The plan also called for a steering committee to oversee implementation of the recommendations.

The reaction to the action plan was generally positive. The action 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," according to a press release jointly issued by the the American Heart Association, the National Women's Health Network, the Society for Women's Health Research, and WomenHeart: The National Coalition for Women with Heart Disease.

"The groups particularly applaud the FDA for finalizing its guidance on the evaluation of sex-specific data in medical device studies and for establishing a steering committee and website to oversee and track progress on implementing the action plan."

But they also said the agency needed to do more. "While the FDA Action Plan is a step in the right direction, the agency must do more than remind and encourage industry to include women and minorities in trials and analyze the data," Cynthia Pearson, executive director of the National Women's Health Network, said in the release. "The FDA must require that companies do this to ensure that that the products women use are safe and effective for them."

Diana Zuckerman, PhD, president of the National Center for Health Research, agreed that the plan sounded nice but did not have enough teeth in it. "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 said in a phone interview.

Instead, the agency should tell the drug companies that, for example, 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 the drug for women; the same would go for not including enough African Americans or Hispanics in a trial.

"Pretty soon drugs will be approved for 30% of the population, and no company is going to want that. The FDA has the authority and responsibility to not approve drugs or devices that are not tested on the largest demographic groups."

Rosamond Rhodes, PhD, director of bioethics education at Mount Sinai School of Medicine in New York City, said she was disappointed that the report didn't mention including children in clinical trials. "That's one glaring omission, and children are another group that particularly is relevant ... because they're developing and their metabolism is different than in adults, and very few drugs on market are adequately tested for children," she told MedPage Today.

Another group not mentioned is pregnant women, she continued. "They talk about women being excluded from research, but they don't talk about why women are often excluded," which is the possibility that the study might harm a developing fetus. "Pregnant women could get any disease other women get, and we want to know how many of these drugs and devices affect pregnancy."