Clinical trials across multiple regions of the world have become common practice. More and more regions/countries are involved in global trials. Multi-regional trials (MRCT) have benefits but also come with a set of Challenges. One of the major Challenges is to better understand the difference in placebo response in various regions/countries in the neuroscience area. The New England Journal of Medicine published an article, "Ethical and Scientific Implications of the Globalization of Clinical Research" in February 2009, and posed some Challenges in shifting the clinical research to the more developing countries. One of the major concerns in clinical trials is a higher than expected placebo response in the neuroscience area. To date, there is no common understanding of how the placebo response differs among countries/regions particularly in developing countries in the neuroscience area.

Through this Challenge our Seeker Client would like to gain a better understanding of the regional variations and differences in placebo response in clinical trials using subjective outcome measures in the neuroscience area with particular emphasis for the indications of depression, general anxiety disorder (GAD), attention-deficit hyperactivity disorder (ADHD), pain and schizophrenia. Specifically, the Seeker is interested in answers to the following questions:

• Does placebo response vary by region / indication?
• Does drug-placebo difference vary by region / indication?
• Does placebo response differ for multi-region trials vs. single region trials / indication?
• Does drug-placebo difference differ for multi-region vs. single region trials / indica