China lives up to outsourcing hype

16/01/2007 - China is now an industry buzzword when it comes to outsourcing and yet another report adds to the list of research recently published that give evidence of the increasing popularity of the country as a location to conduct drug clinical trials.

According to a new report published by the UK Trade and Investment (UKTI) department, there has been a considerable interest by companies in running clinical trials in China and using the clinical data to support their global marketing objectives.

The report, which analyses the Chinese biotech and life sciences industry, said that a prime attraction for companies seeking to conduct clinical trials in China is the country's large population offering a potentially vast pool of patients.

"The main attraction of China is the sheer population; China represents one fifth of the world's population," said Dr Faiz Kermani, co-author of the report, during a UKTI conference held in London last week.

Apart from patient numbers, there are other attractions for conducting clinical trials in China including positive patent attitudes and low costs.

Indeed, outsourcing clinical trials to China can be cost effective for CROs as conducting trials involve lower costs.

"In terms of general running costs, it has been estimated that clinical trials can be conducted in China for around 10 per cent of the equivalent cost in a Western country," said Dr Kermani.

More specifically, the local industry estimates that Phase I trials in China cost 15 per cent of the price in the west, while Phase II studies cost 20 per cent. Added to that is the speed of studies conducted in China.

"One domestic CRO has estimated typical timelines for running a Phase I study involving 30 healthy subjects to three months, which is quite fast", said Dr Kermani.

Meanwhile, a Phase III trial involving 400 subjects was estimated to take a year.

Of course, one needs to take into consideration the nature of the product tested, stressed Dr Kermani. Products for testing in China are categorised as Type III drugs - available in a western market but not in China - , Type II, also known as "me too" drugs, and Type I drugs, which are new products not yet available in the Chinese market or abroad.

Testing and getting market approval for a Type III drug is likely to be quicker while regulatory attitudes tend to be cautious if the drug is to be trialled for the first time in China, the report said.

As far as the quality of clinical trials is concerned, there are still downsides. While Dr Kermani said during the conference that quality was maintained during clinical trials conducted in China despite low costs involved, the issue of regulatory standards still remains.

In the major world regions for drug development, clinical trials are run to ICH GCP (International Conference on Harmonisation - Good Clinical Practices) standards, which is an international quality standard to ensure that clinical trials involving human participants are carried out in an ethical manner.

However, it is not the case in China and therefore, an issue for drug makers seeking to conduct clinical trials exclusively in China is whether the resulting study data will be considered acceptable to western regulatory bodies such as the FDA in the US or the MHRA in the UK or whether it can only be used to support a new drug aimed at the Chinese market.

But, as the report points out, there are many examples that show that this issue won't be a hurdle for long.

"Although some local observers have suggested that China could be used in a pilot capacity for clinical trials to evaluate the potential of a product for a foreign market, the country appears to be more sophisticated in its clinical trial nature," said the report.

Western drug developers are showing increased confidence in using Chinese clinical data to support their global clinical programmes.

A perfect example that illustrates this trend is Pfizer. The drug giant opened a clinical trial centre in Shanghai in 2003 and stated that not only would this be concerned with developing drugs for local approval, but would also form part of the company's global R&D network.

The increasing popularity of using China as a location for clinical trials has also encouraged the growth of the CRO sector and according to the report, there are now around 100 CROs operating in China - a sector set to experience rapid growth over the next decade.

"Outsourcing to China is no longer just a 'hype'. It is now a great opportunity for CROs and companies involved in clinical trials," concluded Dr Kermani.