Asia Pacific, the Growth Force Economic growth remains strong in Asia Pacific markets despite the economic crisis. The pharmaceutical market in Asia is growing at 10-15% in Asia compared to 5-7% in G7 countries (source: Price Waterhouse Coopers). Good Clinical Trial Infrastructure in the Region There is continuous growth in the scientific base and capabilities in Asia, encouraged by local authorities, given the growing contribution of clinical research to the local economy. There are centralized healthcare institutions, well qualified, highly motivated investigators and excellent clinical trial facilities and are comparable to the best in class globally. Trials are supported by clinical trial units and study coordinators. Efficient Regulatory and Ethics Committee Processes With the appropriate approach, the regulatory approval processes in most Asia is no more complex than in the US or Europe, with the exception of China where it is still relatively complex and require long timelines. The trend is among the regulatory authorities within the region is towards reduction of regulatory approval timelines. Regulatory agencies in several countries do provide clear instructions on their processes and requirements for documentation. Most agencies provide this information on their websites that are updated regularly to include the latest requirements and policies. All regulatory agencies are well organized and welcome meetings with sponsors as necessary to facilitate the submission and review process. The majority of healthcare institutions have well organized Ethics Committees (EC) / institutional Review Boards (IRBs) which follow ICH GCP and have now acquired significant experience. ICH GCP as the Only Standard Many countries adhere to ICH GCP in their processes for EC committee submission and regulatory approval. Since 1995, clinical trials in Asia have been predominantly for FDA/EMEA submissions.

Faster Patient Recruitment and Good Retention Asia offers a large and diverse patient pool, with nearly 60% of the world population living in the region. US/EU treatment guidelines are followed in the treatment of disease. There is a large treatment naïve population, with diseases of both developed and developing world, which offers strong prospects for large and rapid patient recruitment. Typically, doctor-patient relationship is strong in Asia, thus securing good patient retention by sites.There are still fewer competing trials compared to the West. Cost Benefits Including investigator sites in Asia can help reduce the overall drug development timelines, with a higher number of patients in fewer sites enable faster patient recruitment. Salary and out of pockets costs are still favorable when compared to Western countries, even if they are increasing. IP Protection IP protection in Asia remains an issue when compared to Western standards. However, there has been significant progress in some key Asian countries to enforce IP protection and implement patent laws. Singapore has established a strong track record for IP protection while China and India have made significant progress in this area. IP protection still has a long way to go in Asia but legislation concerning intellectual property rights (IPR) continues to improve. Logistics There are strict customs regulations within each country in which to comply. Strategies to deal with the specificities of logistics in Asia include building local knowledge of regulations and import procedures related to clinical trials, as well as designing an adequate distribution approach, together with third parties.

Overview of Clinical Research in Asia Pacific

By Christophe Tournerie, MD, CEO M: +65 9739 1948 E: ctournerie@clinactis.com W:  www.clinactis.com