Men, some ethnic groups underrepresented in US eating disorder clinical trials

Older adults, children, men and certain racial and ethnic groups were found to be underrepresented in U.S.-based clinical trials on eating disorders, according to a study published in JAMA Network Open.

“Studies examining the participation of women, minority racial and ethnic groups and older individuals in clinical trials have demonstrated gaps in inclusion; however, to our knowledge, this has not been studied in trials focused on eating disorders,” Laura E. Flores, BA, PhD candidate in MSIA patient-oriented research at the University of Nebraska Medical Center, and colleagues wrote. “There are known disparities in [eating disorder] diagnosis, access to care and lifetime risk.”

“Beyond access, current evidence-based treatments may not be appropriate for all individuals, and sociodemographic factors associated with outcomes have largely only been evaluated for adults with binge eating disorder (BED),” they added. “Studying diverse populations may affect diagnosis, recommended treatments and health outcomes.”

To determine the participant demographics of eating disorder-focused clinical trials, Flores and colleagues included 21 interventional trials conducted within the U.S. in a cross-sectional study. Trials were sourced from ClinicalTrials.gov from January 2011 to January 2021, and researchers collected data on age, sex, race, ethnicity and primary diagnosis, which was classified as anorexia nervosa, bulimia nervosa, binge eating disorder or other.

Of the 21 included trials, 13 (62%) recorded race, and nine (43%) recorded ethnicity. Of the participants with identified race, only 3% were Asian as compared with 6% of the U.S. population, and of those with identified ethnicity, only 13% were Hispanic as compared with 19% of the U.S. population.

Researchers found that none of the trials were exclusive to pediatric participants, with 76% including adults only, and 24% including both children and adults. Of the four trials that allowed adults ages 65 and older, three did not enroll any.

Of the 76% of trials that were not exclusive to female participants, researchers found that female participants were still overrepresented, comprising 83% of total participants compared with 52.1% of the U.S. population.

“This study suggests that populations affected by (eating disorders) are not equitably reflected in clinical trials, particularly children, older adults, men and some racial and ethnic minority groups,” the researchers concluded. “As (eating disorder) prevention, diagnosis, and treatment may vary among different populations, it is important to address gaps in inclusion.”