Partnering in China, Asia-Pacific

—May Ling Chan, Voisin Consulting, corresponding for Applied Clinical Trials

The Asia-Pacific region has many relatively untapped resources: it is home to one third of the world’s population, collectively the region’s economy is growing at a fast pace (particularly in China, Korea and India), and accordingly it has one of the fastest expanding pharmaceutical markets.

Against this backdrop, the first Partnerships in Clinical Trials Asia Pacific conference from IIR was held in Singapore in December 2009. The 2-day conference attracted delegates from large pharmaceutical multinational companies, emerging biotech companies and leading CROs, many of which have a strong established presence in the Asia Pacific.

The take home message—at least from the local industry perspective—was clear, pharmaceutical and biotech companies should include the Asia Pacific region in their global clinical trial programs and the earlier in a product’s development the better.

The rationale is two-fold: (i) from a global perspective, time and cost savings within the AP region will accelerate drug development programs, and (ii) clinical data in the collected in the region will allow sponsors to seamlessly meet the regulatory requirements for local clinical trial data that is required for marketing approval in countries like Japan, China and Korea.

Conceptually, most would agree that a global clinical trial program which includes sites in the Asia Pacific region has the potential to bring time and cost savings and if given a choice industry would like to collect the local clinical data required to meet the national-specific regulatory requirements as quickly and economically as possible. However, the huge potential in Asia Pacific is associated with many challenges present. The region covers a large geographical area and consists of very diverse cultures and languages and varying economic conditions. Availability of qualified and trained professionals and suitable sites are some issues faced by pharmaceutical and biotech companies when running clinical trials there.

Outsourcing to global or local CROs might be a solution to these problems. Selection of a good CRO partner is clearly important. There should be strong quality systems in place for audit processes and data management. Sponsors should also carefully consider whether they require a full service CRO versus selective services such as regulatory affairs, the qualified staff, the AP coverage, the network of key opinion leaders and specific study sites with the right local expertise in that country or extensive experience in certain therapeutic areas.

When looking at the Asia Pacific region, China and India must be considered. Collectively, these two countries have the highest population in the world and their economies are booming. Many pharmaceutical and biotech companies are turning to China and India to run clinical trials. However, one of the major hurdles for China remains the long regulatory approval timelines for clinical trials, while in India, ethical standards for clinical trials is an area of controversy.

Regardless of the challenges, the Asia Pacific remains a very attractive option for clinical research. Increasing difficulty in patient recruitment and high costs of running clinical trials in the West will push pharmaceutical and biotech companies to look for solutions elsewhere. The region is also doing its part to improve the perception Western counterparts have of it through new regulations and guidelines to ensure good clinical practices for starters. These measures will certainly work to increase the number of clinical trials in Asia Pacific in the future.