Clinical outcome assessment (COA) in multi-cultural studies requires particular caution due to differences in language, culture, education, and differing standards of care. Each of these aspects presents a potential source of variability in measurement outcomes. If not adequately managed, this variability can potentially jeopardize the accurate capture of the targeted concepts and make the demonstration of treatment benefit more difficult. Cross-cultural equivalence of COAs being used in multi-cultural studies is, therefore, of particular importance. This workshop will present the challenges and discuss possible solutions related to this question including qualitative methods to minimize cross-cultural variability in measure development and translation, quantitative methods for exploration of cross-cultural equivalence of COAs, methods to assess whether a difference is a translation issue or cross-cultural difference, and suggestions for managing imperfect cross-cultural equivalence when using clinical trial data for treatment comparisons.
