BEIJING – Asia is rapidly becoming the location of choice for clinical studies by many leading drug developers, with the number of studies in East Asia already topping 14,000, and Mainland China, Hong Kong, South Korea and Taiwan emerging as popular locations.

The focus is moving from the south to the east.

“Asia’s clinical trials landscape is beginning to reshape itself,” said Alex Wong, assistant clinical director at Sanofi SA. “With new areas of opportunity emerging, the region remains an integral part of major drug developers’ global programs.”

Pharmaceutical and biotechnology companies still are making significant scientific investments, including building new manufacturing or R&D facilities in Asia. That ongoing investment opens more doors for more clinical trials.

At the same time, contract research organizations (CROs) are growing and expanding into new countries. They are investing more in training to ensure investigators meet Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) standards, Wong said during China Trials, a global clinical development summit in Beijing late last week.

Part of the driver is the size of the population and the diversity within it. There are literally hundreds of millions of candidates for both new treatments and clinical trials.

But there are challenges.

In China, for example, it takes a relatively long time for studies to start. The approval process for trials in China is the longest in the world. On average, it takes at least a year or 18 months for regulators to approve a trial.

Cost is another issue. Nevertheless, the clinical trial infrastructure has begun to consolidate and mature. Growth is also visible in South Korea and Japan.

But the same cannot be said for India. The other regional giant in terms of population, India offers a more difficult environment. Regulatory concerns have caused a dramatic drop in the number of trials run in that country as global sponsors and CROs find it increasingly difficult, if not impossible, to run trials there.

Just a few years ago the industry projected that 15 percent of global clinical trials would be conducted in India by 2011. After all, the country offers millions of treatment-naïve patients, low operating costs and a rising incidence of Western diseases. Yet, two years after that target date, only 1.5 percent of studies registered globally are done in India according to ClinicalTrials.gov.

The number of registered interventional studies in India dropped 25 percent between 2010 and 2012, while the number of investigators fell by 9 percent over the same period.

Many sponsors and scientific agencies stopped conducting clinical trials in India after the government amended its rules for testing new drugs. Most troubling was a requirement for companies to compensate clinical trial participants who experienced serious adverse events or death, regardless of whether the event was caused by the study drug or a preexisting condition. Volunteers who received placebo instead of the active study drug also were eligible for reimbursement.

So it’s not surprising that during the past 18 months, sponsors and CROs have shifted their clinical trial activities to other, more welcoming, Asian markets like Mainland China, South Korea, Thailand and Japan.

Mainland China may have benefited most, particularly in terms of the number of registered interventional studies, which has risen by almost 90 percent from five years ago.

A series of regulatory reforms has helped cutting short the lengthy process.

“Regulators have adopted a fast-track process that allows approvals in seven to 12 months for studies involving novel agents, unmet medical needs and small molecules,” Wong said.

In all those markets, however, there are a number of considerations that come into play when selecting a CRO to run a trial.

The first is an institutional understanding of the different requirements in countries in Asia Pacific. That includes health care standards and practices, doctor-patient relationships, regulatory requirements, ethnicity and culture, income disparity and varying standards of living and resource turnover management.

The second important consideration is experience and capability. That includes functional ability: the capability to provide full service from the moment the first subject is registered to the completion of Phase IV trials.

Most sponsors are most concerned with the history and quality of trials and the cultural fit with the CRO as well as costs. Access to capabilities and recourse utilization are key deciding factors to outsource clinical development.

“Because of the diversified environment of Asia, CROs and sponsors should have a partnership relationship,” said Vivian Chang, assistant director of clinical operations at Sanofi. “CROs should take the ownership to perform the projects as their own; from a sponsor’s point of view, we should also trust the selected CROs.”