A decade ago, clinical trial sponsors routinely excluded low- and middle-income countries such as India and China from participation. These regions contribute large numbers of patients to pivotal trials across a range of clinical conditions. For example, in China the number of pharmaceutical company–sponsored trials doubled between 2005 and 2010. Today, more than 3000 trials are under way in China, a large proportion of which are sponsored by global pharmaceutical companies.1 The key drivers for this change include reduced costs due to lower investigator fees and staff salaries and larger patient numbers, given the greater population sizes and disease burdens. Additionally, enhanced access to treatment-naive participants is thought to be an advantage in certain circumstances. Moreover, the belated acceptance that the emerging markets will soon be the largest global market for pharmaceutical sales is also driving the shift in focus. However, the rapid expansion of clinical trial activity in emerging markets has raised concerns, including questions about the quality of data generated and the relevance of the products being tested to local health care priorities.
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JAMA 2013-09-03, Vol. 310, No. 9, Author Audio Interview
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