Meghan E McGarry1, Susanna A McColley2. 1. 1 Department of Pediatrics, University of California San Francisco, San Francisco, California; and. 2. 2 Department of Pediatrics, Northwestern University, Chicago, Illinois.
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.
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.
Entities:
Keywords:
clinical trials; cystic fibrosis; ethnic groups; minority groups
Authors: Muhammad Rizwan Sardar; Marwan Badri; Catherine T Prince; Jonathan Seltzer; Peter R Kowey Journal: JAMA Intern Med Date: 2014-11 Impact factor: 21.873
Authors: Ozgül M Alper; Lee-Jun C Wong; Suzanne Young; Michelle Pearl; Steve Graham; John Sherwin; Eliezer Nussbaum; Dennis Nielson; Arnold Platzker; Zoe Davies; Allan Lieberthal; Terry Chin; Greg Shay; Karen Hardy; Martin Kharrazi Journal: Hum Mutat Date: 2004-10 Impact factor: 4.878
Authors: H A Tejeda; S B Green; E L Trimble; L Ford; J L High; R S Ungerleider; M A Friedman; O W Brawley Journal: J Natl Cancer Inst Date: 1996-06-19 Impact factor: 13.506
Authors: David Wendler; Raynard Kington; Jennifer Madans; Gretchen Van Wye; Heidi Christ-Schmidt; Laura A Pratt; Otis W Brawley; Cary P Gross; Ezekiel Emanuel Journal: PLoS Med Date: 2005-12-06 Impact factor: 11.069
Authors: Evan T Sholle; Laura C Pinheiro; Prakash Adekkanattu; Marcos A Davila; Stephen B Johnson; Jyotishman Pathak; Sanjai Sinha; Cassidie Li; Stasi A Lubansky; Monika M Safford; Thomas R Campion Journal: J Am Med Inform Assoc Date: 2019-08-01 Impact factor: 4.497
Authors: Andrew M Zeiger; Meghan E McGarry; Angel C Y Mak; Vivian Medina; Sandra Salazar; Celeste Eng; Amy K Liu; Sam S Oh; Thomas J Nuckton; Deepti Jain; Thomas W Blackwell; Hyun Min Kang; Goncalo Abecasis; Leandra Cordero Oñate; Max A Seibold; Esteban G Burchard; Jose Rodriguez-Santana Journal: Pediatr Pulmonol Date: 2019-10-30