—Brad Miller, XenoTech
A: When choosing a clinical trial site or region, there are many factors that come into play in making a decision: pricing, speed of enrollment, regulatory speed and approval, quality, disease population, and sponsor comfort level (as well as past experiences in that region). Emerging markets do tick many of these boxes, though some sponsors are not comfortable venturing outside their comfort zone of the U.S. or western Europe.The major drivers for working in emerging markets is pricing and access to patient populations (perhaps naive populations, at times). In some markets, clinical research can be 50%+ cheaper than comparable studies in the U.S. or western Europe. As expected, this is very attractive to sponsors with limited resources or pressures from senior management to keep budgets low. In addition, recruitment in these areas can be much quicker that traditional markets. The populations are larger and eager to participate in clinical studies. For example, India is an excellent resource for diabetic patients (61 million compared to 24 million in the U.S.) — and the cost for conducting studies in India runs about a two-thirds to half cheaper than in the west.
Many of the sponsors that will not work in developing markets have either had a bad experience or have the perception that the quality will be lower in these areas. Some of these fears are unfounded, though there any many stories out in the industry detailing the challenges that some organizations have faced. Also, regulatory approval in emerging countries can be a barrier. While many emerging countries make it quite easy to conduct clinical research studies, others pose substantial regulatory challenges. These issues can cost a lot of money but more importantly can slow the process down by weeks and even months.
Unfortunately, there is no easy answer to your question — each sponsor company has different decision criteria. However, there is no doubt that it is cheaper to conduct clinical studies in emerging countries. This along with access to patient populations are clearly the top incentives for working in developing countries to conduct clinical research studies.
—Terry Novak, Norwich Pharmaceuticals