Prevalence and significance of race and ethnicity subgroup analyses in Cochrane intervention reviews

Bloche MG. Race-based therapeutics. N Engl J Med 2004; 351(20): 2035–2037.

U.S.Food and Drug Administration (FDA). Guidance for industry: collection of race and ethnicity data in clinical trials. Washington, DC: U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Center for Devices and Radiologic Health (CDRH), Office of the Commissioner (OC); October 2016, http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm126396.pdf (accessed 26 March 2019).

U.S. Food and Drug Administration (FDA). Evaluation and reporting of age-, race-, and ethnicity-specific data in medical device clinical studies. Washington, DC: U.S. Department of Health and Human Services, Food and Drug Administration, Center for Devices and Raiological Health (CDRH), Center for Biologics Evaluation Research (CBER), Office of the Commissioner (OC): 12 September 2017, https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM507278.pdf (accessed 26 March 2019).

National Institutes of Health (NIH). NIH policy and guidelines on the inclusion of women and minorities as subjects in clinical research, http://grants.nih.gov/grants/funding/women_min/guidelines.htm (accessed 26 March 2019).

Taylor AL Wright JT Jr. Should ethnicity serve as the basis for clinical trial design? Importance of race/ethnicity in clinical trials: lessons from the African-American Heart Failure Trial (A-HeFT), the African-American study of kidney disease and hypertension (AASK), and the antihypertensive and lipid-lowering treatment to prevent heart attack trial (ALLHAT). Circulation 2005; 112(23): 3654–3660; discussion 3666.

Ramamoorthy A Pacanowski MA Bull J , et al. Racial/ethnic differences in drug disposition and response: review of recently approved drugs. Clin Pharmacol Ther 2015; 97(3): 263–273.

Wallach JD Sullivan PG Trepanowski JF , et al. Sex based subgroup differences in randomized controlled trials: empirical evidence from Cochrane meta-analyses. BMJ 2016; 355: i5826.

Lin SS Kelsey JL. Use of race and ethnicity in epidemiologic research: concepts, methodological issues, and suggestions for research. Epidemiol Rev 2000; 22(2): 187–202.

Hemmingsen B Gimenez-Perez G Mauricio D , et al. Diet, physical activity or both for prevention or delay of type 2 diabetes mellitus and its associated complications in people at increased risk of developing type 2 diabetes mellitus. Cochrane Database Syst Rev 2017; 12: CD003054.

U.S. Census Bureau. About Race. https://www.census.gov/topics/population/race/about.html (accessed 1 September 2019).

Institute of Medicine. Race, ethnicity, and language data: Standardization for health care quality improvement. Washington, DC: The National Academies Press, 2019 https://www.ahrq.gov/sites/default/files/publications/files/iomracereport.pdf (accessed 1 September 2019).

Kent DM Rothwell PM Ioannidis JP , et al. Assessing and reporting heterogeneity in treatment effects in clinical trials: a proposal. Trials 2010; 11: 85.