Minorities are Underrepresented in Clinical Trials of Pharmaceutical Agents for Cystic Fibrosis

Abstract

Rationale: Members of racial or ethnic minorities make up an appreciable proportion of patients with cystic fibrosis (CF) and have worse outcomes than non-Latino white individuals. Between 1,999 and 2014, the CF Foundation Patient Registry reported an increase in minorities from 5 to 8.2% for Latinos, from 3 to 4.6% for black individuals and from 1.4 to 3.1% for "Other."Objectives: To evaluate the representation of racial and ethnic minorities in pharmacology clinical trials for CF. Methods:We analyzed pharmacology clinical trials in CF published between 1999 and 2015 by searching PubMed and published study reference lists for qualifying study reports. We examined whether the race and ethnicity of study subjects were reported and, if so, what percentage of subjects represented major minority groups.Measurements and Main Results: Among 147 pharmacology clinical trials, only 19.7% reported the race or ethnicity of study subjects. Latinos were verified as included in 7.5% of clinical trials, black individuals in 6.8%, and Asians in 2.0%. Inclusion of subjects described as "Other race" was reported in 7.5% of trials. In 29 clinical trials that reported race and ethnicity, the percentage of minorities included as subjects was 2.0% for Latinos, 1.0% for black individuals, and 0.1% for Asians.Conclusions: Although CF disproportionately affects non-Latino white individuals, members of other racial or ethnic groups are proportionally underrepresented in CF pharmacology clinical trials. Inadequate inclusion of minorities and failure to report the racial or ethnic background of study subjects limits information about factors influencing drug response and may contribute to health disparities for minorities with CF.Keywords: cystic fibrosis; minority groups; ethnic groups; clinical trials

Risk factors for mortality before age 18 years in cystic fibrosis

“…A single‐center study showed reduced health literacy in parents of Hispanic CF patients, suggesting that improving health literacy and creating tools for use in low health literacy populations could be a target for intervention. Another important strategy to reduce health disparities among minorities with CF might be to increase minority participation in clinical trials …”

“…Another important strategy to reduce health disparities among minorities with CF might be to increase minority participation in clinical trials. 14…”

Pulmonary function disparities exist and persist in Hispanic patients with cystic fibrosis: A longitudinal analysis

“…Improvements in pulmonary function in CF are attributable, at least in part, to new medications. However, these medications have not been sufficiently studied in Hispanic patients, as Hispanic patients were proportionally underrepresented, taking part in only 7.5% of studies . When included, Hispanic patients comprised only 2% of patients, which is insufficient to investigate ethnic differences in drug response.…”

Minority Representation in Migraine Treatment Trials

“…In brief, minority research participation may be partially explained by distrust of the medical research community, 10 based in-part on a history of exploitative research. 20 This research underrepresentation has been documented in diverse fields including cancer, 21-25 cardiovascular disease including heart disease, hypertension, and vascular surgery, 26-31 orthopedics, 32 liver disease, 33 gynecologic disease, 34 lung disease, 35 infectious disease, 36 and mental health. 13 These studies identified researcher/provider factors 9,14 -such as implicit bias and a desire to recruit the "ideal" study patient 15 -to explain the decreased rates of minority participation in clinical trials.…”