Early Phase Trials: Reevaluating Asian Markets

Pharma IQ

Much has been made in recent years of the shift of research and development (R&D) activities, and in particular the movement of clinical trials to Asia and its rapidly expanding emerging markets.

As far back as 2008, a PwC report found China, followed by India, Korea and Taiwan, were the top locations for pharmaceutical outsourcing, thanks to the region's strong R&D potential.

One respondent to the survey noted: "Within five to ten years, we will be moving from 'made in China' to 'discovered in China'."

However, when it comes to early phase clinical trials and the unique challenges such research presents, the Asian market paints a slightly different picture, with tight restrictions still in place in some countries and predictions that phase I development in the region is unlikely to catch up to that seen in more established markets.

Phase I Trials

In its report into the globalisation of clinical trials, released in July 2009, the Association of Clinical Research Organizations (ACRO) noted 76 percent of all phase I studies take place in three well-developed markets; the United States, Canada and the Netherlands.

"Although emerging countries may eventually play a larger role in Phase I bioequivalence studies for established drugs, it is expected that "the more novel, sophisticated, complex [Phase I] studies [will] predominantly play out in North America and Western Europe," the report noted.

The report, which also looked into the ethical aspects of conducting clinical trials in emerging markets, concluded contrary to popular belief there are often more stringent controls in place than in other markets, citing the barriers to early phase clinical trials in India as a particular example.

This restriction was also named as a key factor in the slower than expected growth within the Indian clinical trials market by experts cited in a recent article in the Business Standard.

India was expecting to hold 15 percent of the global market for clinical trials by 2011, but according to figures cited by the news provider the growth rate is in fact declining.

Aaron Schacht, executive director and chief operating officer of global external R&D at Lilly Research Laboratories, told the news provider: "For Phase I, Singapore, Korea and China are the most preferred destinations in south-east Asia."

Until India develops a more favourable regulatory regime for such trials, it's unlikely this assessment will change.

Advantages and CROs

These difficulties, however, have not stopped all Phase I trials taking place in India. Contract research organisation (CRO) Quintiles, for example, entered into a partnership with Apollo Hospitals in 2009 which saw it open a Phase I clinical trial unit in Hyderabad.

The unit opened in early 2010 and can be used for clinical trials of compounds developed both domestically and internationally.

Eddie Caffrey, senior vice president, Global Phase I, explained: "This new Phase I unit will draw on the existing experience of Quintiles staff in India, including our established cardiology group; the expertise of local clinicians and scientists and Quintiles' global experience in Phase I, to deliver studies in accordance with global standards and within the recently revised regulatory framework in India."

Outside India, PRA International invested in offices in South Korea, an increasingly important hub for clinical trials in the region. The CRO said much of this was due to the South Korea National Enterprise for Clinical Trials, which has increased the number of multinational clinical trials at all stages in the country.

Korea's advantages as a centre for R&D were said to include strong regulatory and ethical systems, which comply with internationally harmonised good practice guidelines, skilled professionals and advanced facilities.

Another key advantage, one which in fact the whole Asian holds, is the potential to access to large patient pools.

And, with the ACRO report identifying the "number of patients per trial is also increasing across all phases of clinical research", this is one factor which is likely to see the Asian region increasingly in popularity for all clinical trials for years to come.