Women to be included in medical studies after years of neglect

EDINBURG, Texas (ValleyCentral) — For decades, women and other underrepresented individuals were rarely, if ever, included in clinical research studies. Health professionals argue that the absence of medical research has caused serious negative consequences.

Dr. Fatimah Bello is the Program Director for the University of Texas Rio Grande Valley Knapp Medical Center Internal Medicine program. She said societal norms and gender biases were at the heart of how medical research used to be conducted.

“It’s not one size fits all, right?" Bello said. "We have physiological differences in male and female, and some of those things affect how we metabolize things for example, how we respond to medications."

Including a wider range of people in the research process helps in understanding those differences. The more research that is done, the better medical experts can treat and diagnose patients.

“How women or even minorities, how we respond to certain medications, certain conditions affect us differently and that has helped improve treatment outcomes," she said.

Bello credits a 1993 law for being instrumental in improving the rates of inclusion.

The National Institutes of Health Revitalization Act established guidelines for the inclusion of women and minorities in the clinical research process.

The policy laid out how clinical trials shall be conducted and are subject to review by the Department of Health and Human Services. The law requires researchers to note whether women or members of minority groups react differently than other subjects in the trial.

“The FDA even went a step further," Bello said. "For all the studies the FDA is going to fund, women have to be included. But in addition, we have to have gendered analysis."

The data that is collected is broken down into subcategories to better understand how each population is affected. More detailed information allows healthcare to become more personalized and precise.

“As we are moving towards precision medicine, you know now, with technology, we don’t have any excuses to exclude anybody anymore. Based on what’s the potential for medicine that we have right now," she said.

According to Bello, the situation has improved but more work is still needed.

She said the updated DHHS policies have been helpful, but researchers need to figure out how to make it easier for women to participate.

“Women might have different challenges that make them not want to come. So how do we meet them there? You know, policies like that,” Bello said.