Representation of blacks, women, and the very elderly (aged > or = 80) in 28 major randomized clinical trials.
OBJECTIVE
The purpose of this manuscript is to precisely quantify the representation of women, blacks, and very old (aged 80 or more) participants in 28 past or ongoing randomized clinical trials on hypertension, cardiovascular disease, renal disease, and diabetes mellitus.


METHODS
Selection of the 28 studies was arbitrary, based primarily on the reference being often quoted or cited as relevant data for women, blacks, the elderly, or persons with diabetes mellitus.


RESULTS
Twenty-three of the 28 studies enrolled a majority of men. Many of the completed trials had an under-representation of blacks (0% to 8%). An adequate number (1,091) of very old (aged 80 or more) persons have been studied for isolated systolic hypertension, but the number of such patients thus far studied for diastolic hypertension is too small to allow evidence-based recommendations for therapy. Reported studies in diabetes have included a majority of men (average, 58%) and four of the five trials reviewed enrolled relatively few blacks (average, 4.6%).


CONCLUSIONS
Women, blacks, and the very old (aged 80 or more) have been under-represented in many past randomized clinical trials, but ongoing studies will resolve this discrepancy in most instances. The Women's Health Initiative (WHI) will provide data on 161,861 multi-ethnic postmenopausal women. ALLHAT results will include 15,133 hypertensive blacks, and AASK will have 1,094 hypertensive blacks with nephrosclerosis. ALLHAT, STOP-2, and HYVET will include more than 5,000 persons aged 80 or more. Future trials on diabetes mellitus must be designed to improve the representation of women and blacks.
Hall
W D
WD
Emory University School of Medicine, USA. whall@emory.edu
D001741:Black or African American; D000368:Aged; D000369:Aged, 80 and over; D002318:Cardiovascular Diseases; D003920:Diabetes Mellitus; D005260:Female; D006801:Humans; D006973:Hypertension; D007674:Kidney Diseases; D008297:Male; D018579:Patient Selection; D016032:Randomized Controlled Trials as Topic; D014930:Women