By Julio G. Martinez-Clark, CEO, bioaccess
Clinical research has changed in the past two decades, shifting from industrialized Western countries to so-called emerging or low-income and middle-income countries (LMICs) in Eastern Europe, Latin America, and Africa.(1) The globalization of research is receiving considerable attention due to the increasing number of offshored research and development (R&D) activities from the United States, Europe, and Japan. Recent studies have challenged the traditional thinking of cost-related factors as the primary reason for offshoring clinical trials. They have shown the importance of the recruitment of human subjects in trials. The “recruitment crisis” in the home country seems to be the main contribution to and a key driver of offshore clinical research activities.(2)
This article examines the need to conduct clinical trials outside the U.S. (OUS), addresses the recruitment crisis in the U.S., reviews the incentives for clinical trials overseas, and explores the growth of clinical trials in Latin America. We will profile Colombia as an example of a country committed to attracting more foreign investment in clinical trials.