Recent suggestions that China is pulling ahead of India as a preferred location for clinical trials outsourced from established markets are borne out by the latest figures from clinicaltrials.gov, the on-line registry established by the US National Institutes of Health (NIH) in 1997.
The registry includes 287 clinical trials currently ongoing – either recruiting patients or not yet recruiting – in China, compared with 270 studies in India. In terms of clinical trials that have been completed, terminated or withdrawn, China has 148 listed and India 123.
The data from clinicaltrials.gov provide only a snapshot of global trends in study placement. While the NIH website gives access to by far the largest publicly available registry of clinical trials in the world, only federally and privately funded studies of experimental treatments for “serious or life-threatening diseases and conditions” have to be lodged there. Registration of any other trials is voluntary. In total, clinicaltrials.gov lists 41,000 studies from 50 US states and more than 140 countries.
Nonetheless, the observed swing from India to China does chime with recent trends in pharmaceutical company investment, with a number of multinationals such as Eli Lilly, Sanofi-Aventis, AstraZeneca, Novartis and GlaxoSmithKline stepping up their commitment to research and development in the latter country. A number of reasons have been cited for this, including costs, a solid medical infrastructure, a large and often treatment-naïve patient population, a national drive for innovation and an improved intellectual property regime.
Notably, the dismissal in August of a High Court challenge by Novartis to India’s Patents (Amendment) Act, following the rejection of a controversial product patent application for the anticancer Glivec (imatinib mesylate), prompted the company to warn that it would be switching hundreds of millions of dollars in planned investments from India to more hospitable territories over the next few years.
No punishment, Vasella claims
The High Court ruling was “not an invitation to invest in Indian research and development, which we would have done”, Novartis’ chief executive, Daniel Vasella, told the Financial Times. “We will invest more in countries where we have protection. It’s not a punishment, it’s just a question of the culture for investment. Do you buy a house if you know people will break in and sleep in your bedroom?”
A recent report on outsourcing clinical trials by US-based Arrowhead Publishers put China at the top of a location attractiveness index that ranked 31 “ascending” markets for clinical development according to seven measures of attractiveness such as study costs, population/patients and disease incidence. China scored an average index of 6.48 while India was in second place with an average of 5.66.