In 2004, an estimated $55bn was spent on pharmaceutical R&D, with clinical development accounting for around $43.5bn. Even though a continued rise is forecasted, the industry must see greater productivity from this development spend. New patient populations and reduced recruitment time and study duration are required to keep production on the rise. Many geographic areas have promised to deliver, but the industry is now looking to the East and wondering if China could hold the key. The region has great potential but also its own unique challenges, especially for central laboratory service (CLS) operations. These challenges must be understood and overcome if the promise of the region is to be realised.

The reason why China might be the solution lies within the nation itself. China is home to more than 1.3 billion people, making up 22 per cent of the world’s population. Not only does that provide the world’s largest source of clinical trial participants, the drug development potential is also huge. Since China joined the WTO in 2001, pharmaceuticals are no longer heavily protected from competition abroad. The State Drug Administration, the Chinese equivalent of the FDA, has projected imported drugs and drugs produced by sino-foreign joint ventures will eventually share 70 per cent of the market. This, coupled with the growth of the Chinese pharmaceutical market at 15–17 per cent year-on-year, presents a unique opportunity for those willing to face the test.

The number one hurdle is the white paper restricting the transportation of whole blood samples outside of mainland China is the Human Genetic Resource Administration of China (HGRAC). This severely impacts a CLS’s routine mode of operation, as shipping the samples to another central location outside the trial country is not an option. Therefore, access to high-quality CLS services in mainland China is a significant bottleneck to more conducted trials.

To further understand the nature of this problem, we need to examine the vital elements of a CLS operation. CLS is the crucial link between sponsoring drug companies and hundreds of scattered investigator sites. It provides technically sound and scientifically valid clinical laboratory results from samples received from patients enrolled in trials. Sample collection, logistics, instruments, methods, sampling procedures and data management are all tightly controlled to allow one single GCP-compliant clean database to be submitted in support of the safety and efficacy of a new drug.

As with any emerging area, there had previously been significant doubts over the quality standards and logistical infrastructure in the region. However, demands from researchers resulted in significant improvements in quality and regional adoption of ICH GCP standards. Added to this are a growing number of qualified investigator sites, an excellent transportation infrastructure and, above all, the Asian drive to succeed.

There are now an estimated 30 major multinational pharmaceutical companies carrying out clinical trials of new medicines in China, but there are only three accredited multi-national central laboratories. Two are located in Beijing, with one emerging operation in Guangzhou province, near Hong Kong.

For CLS operations, it is clear that a quality GCP lab in mainland China is a prerequisite for success. Local logistics, harmonised instruments and methods, a single, fully integrated database, and a thorough local knowledge of customs and regulations are all key to successful operations. While these are already in place for a small number of providers, until a greater number of high-quality operations have a foothold in this challenging environment, the potential gains of running clinical trials in China may not be fully realised