Clinical Trials for Crohn Disease May Lack Adequate Minority Representation

Crohn illness and intestine disease or crohns medical concept as human digestive colon with inflammation symptoms causing obstruction as a 3D illustration.
Investigators assessed the reporting of race and ethnicity in placebo-controlled trials for patients with Crohn disease.

Minority groups may be under-represented in Crohn disease (CD) drug development, and a majority of CD studies do not fully report race, according to a study in Gastroenterology.

Researchers conducted a systematic literature review of all induction and maintenance placebo-controlled trials of different therapeutic classes involving adult patients with active CD.

A total of 91 induction and 45 maintenance trials were included in the analysis. Among the induction trials, 48.4% (44/91) were phase 3, with 68.1% investigating biologicals. All induction studies reported sex, and 54.9% (10577/19476) of participants were women.

A total of 20 induction trials (22%) reported race (n=5343 patients) as a baseline characteristic, with most patients identified as White/Caucasian (90.5%). Ethnicity was reported in 1 induction study, noting it as Hispanic/Latino vs non-Hispanic/Latino.

In addition, 8 of the 20 induction studies reported race as White/Caucasian compared with non-White/Caucasian, and 12/20 studies reported other races — Black/African American (11/12 studies; 38/3338 patients [2.6%]), Asian (12/12 studies; 134/3338 patients [4%]), American-Indian or Alaska-Native (2/12 studies; 3/3338 patients [0.09%]), and Native-Hawaiian/Pacific Islander (1/12 studies; 1/3338 patients [0.03%]). Of the 20 induction studies, 3 used the term “ethnicity” when referring to race, and 2/12 studies that reported race included Hispanic/Latino population as a race subgroup.

In the maintenance trials, 77.8% (35/45) were phase 3, and 51.1% (23/45) investigated biologicals. All of the studies reported sex, and 54.8% (5303/9684 patients) of participants were women. A total of 12 maintenance studies reported race, and all reported White race (92.2%; 3078/3339 patients); 3 studies also reported other races — Black (3/3 studies; 28/1230 patients [2.3%]), Asian (3/3 studies; 33/1230 patients [2.7%]), or Native-Hawaiian/Pacific Islander (1/3 studies; 1/1230 patients [0.08%]). Ethnicity was not reported in any of the maintenance studies.

“Ideally, patients enrolled in clinical trials of novel agents should reflect the future population who will eventually benefit from the intervention,” stated the study authors.

Clinical trial enrollment data from the United States Food and Drug Administration indicate that 5% of participants are Black/African American and 1% are Hispanic/Latino, researchers noted. The National Institutes of Health reported a 36.5% enrollment rate of racial minorities for its domestic clinical research.

To increase diversity within CD trials, collaborative initiatives are needed. “To improve clinical trial recruitment, we propose the following: Improve outreach and education about access to clinical trials to patients from different races and ethnicities, raising awareness among physicians and industry, mandatory reporting and detailed breakdown of race/ethnicity in trials, and obtaining support of influential bodies such as CONSORT,” the researchers recommended.

Disclosure: Some of the study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.


Sedano R, Hogan M, McDonald C, Aswani-Omprakash T, Ma C, Jairath V. Underrepresentation of minorities and under-reporting of race and ethnicity in Crohn’s disease clinical trials. Gastroenterol. Published online September 27, 2021. doi: 10.1053/j.gastro.2021.09.054