Exclusion of certain groups from clinical research.

Recent evidence indicates that certain groups such as women, ethnic minorities, the elderly, and the poor may be underrepresented in clinical research. A review was conducted of 754 approved research protocols from one tertiary care center over a 2-year period (1989, 1990) to examine demographic characteristics of subjects. Most protocols (81.4%) included both men and women; 56.6% included people over age 65. About three-fourths described exclusionary criteria. Exclusions for which a justification was least frequently explicated were for age (44.9%), socioeconomic status (42.9%), and race (38.1%). In nursing protocols, only 26.6% included a justification for age. In this study, the elderly, poor and ethnic minorities were found to be excluded without identifiable justification from research protocols. While such disparities must be corrected, there are certain research design considerations that should be taken into account to assure that research questions are answered in the most efficient manner for the most representative group.

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