BRIC Countries Contribute to Research

Contract research organizations (CROs) are working closely with pharmaceutical companies to determine where to conduct global clinical development programs. Market growth, greater regulatory requirements, increased cost pressures, and significant patient recruitment and site selection challenges have led pharmaceutical companies and CROs to make larger investments in four countries: Brazil, Russia, India, and China (BRIC).

The BRIC countries, comprise more than 40 percent of the global population. China is now the world's third-largest pharmaceutical market, and from 2006-2009, Brazil, Russia, and India had more industry sponsored Phase II-IV trials than any other emerging country. Each of these countries represents a shift in global economic expansion away from developed countries to countries with newly advancing economies. As biopharmaceutical companies continue to expand their drug discovery, development, and commercial programs, BRIC countries will continue to be given consideration as potential areas to conduct global trials.

One driver for growth is the large number of patients these countries offer. Large patient populations tend to be clustered in and around cities, making access to clinical trial sites easier. BRIC countries also have highly-educated, experienced investigators. In addition, BRIC governments are working to make it easier to conduct trials in country, and there is an increasing desire to commercialize compounds.

China, for example, has more than 125 universities and colleges of medicine and pharmaceuticals with approximately seven million people enrolling in doctoral and master's study programs, giving the industry a large pool of potential investigators and researchers. However, there continues to be a shortage of experienced clinical research associates in the country. As more companies move into China, the market will continue to become more competitive.

BRIC countries offer well-developed centralized healthcare systems; they often require fewer sites to recruit a large number of patient groups. As a result, clients are able to complete enrollment and advance development of their clinical programs more quickly.

Clinical trials are being conducted in BRIC countries across a broad range of areas, including hematology/oncology, cardiovascular, metabolic disorders, CNS diseases, and infectious diseases. A few years ago the majority of trials were limited to infectious diseases.

The growth of clinical research in BRIC countries has led the US Food and Drug Administration to open offices in China, India, and Latin America. While these new offices are initially focused on monitoring quality in manufacturing, inspections of research sites are being conducted and are likely to increase over time. Inspections completed in emerging markets, to date, have shown that the quality of research is in line with the developed world.

Paul Colvin Executive Vice President, Global Clinical Development PPD, Inc.