The Emerging Role of Patient-Reported Outcomes (PROs) in Clinical Trials: An Indian Perspective

Abstract

In an attempt to reduce costs of clinical trials and increase recruitments, pharmaceutical companies have been shifting their trials to offshore locations in Asia, Africa, the Middle East, Eastern Europe, and Latin America. Hence, methods for conducting clinical trials need to be adapted to the varying languages, cultures, ethnicities, and socioeconomic groups of these regions. This is of prime importance in the collection of patient-reported outcome (PRO) data. To ensure correct capturing of PRO data from multiregional sites, it is important that the tools for data collection are adapted to the respective cultures, and the data collected have the same interpretation across cultures (cross-cultural equivalence). This article deals with challenges involved in the adaptation of PRO measures to various cultures, especially of those used for multiregional trials being conducted in the developing world.