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With an estimated population of 3.9 billion, the Asia/Pacific region has a huge potential patient base for clinical trials. Centers already qualified to run clinical trials include China, Hong Kong, India, Korea, Singapore and Taiwan. Kendle’s existing operations in the region include Australia, China and India.
Australia, with a reputation for high-quality, cost-effective clinical research, high levels of patient recruitment and a well-developed science and telecommunications infrastructure, is an attractive place to undertake your clinical trial. The regulatory system is also conducive to conducting clinical trials. Australia’s regulatory body is the Therapeutic Goods Administration (TGA), an internationally-respected body whose rulings are recognized by counterpart organizations worldwide, including the FDA and the EMEA.
India is fast becoming one of the most exciting regions in the world to conduct clinical trials with improved efficiency, high-quality and value. In addition, due to the climatic, geographical and socioeconomic diversity of the country, there is an equally diverse range of diseases within the population.
China is also important in providing access to significant numbers of special patient populations. With a population of more than one billion, the opportunity to conduct
clinical trials in China, together with a thriving biopharmaceutical industry, provides a good environment for clinical development.
Top reasons to conduct a clinical trial in Asia/Pacific
- Population, population, population – the region is a powerhouse for recruitment, with multiple cultures, languages and ethnicities. India is an excellent example, with a total population of one billion, some 200 million of whom are clustered in large cities. Thirty-seven percent of India’s population is aged 14 or younger, making it a desirable place to conduct pediatric studies.
- Quality – the Asia/Pacific region is striving to work towards internationally-recognized standards for clinical trials. In Australia, nearly twice as many study sites are covered by a clinical trial coordinator compared to Europe; India is following this lead. In India, 95 percent of the local ethics committees meet ICH-GCP requirements. Most sites are trained formally in ICH-GCP. China has 125 sites qualified for clinical trials.
- Regulatory environment – although variable across the region, countries with longer times to approval (for example, China and India) consistently provide recruitment at or above expectations due to patient population availability. Other countries within the region, such as Australia, have favorable regulatory systems, enabling study approval in 8–12 weeks and meeting recruitment timelines and targets.
- Lower costs – conducting studies in the Asia/Pacific region will have lower R&D (or associated) costs in comparison to the United States or Europe. They are 30 to 50 percent lower across the entire region.
- Business environment and infrastructure – Asia/Pacific countries generally have excellent IT infrastructure and business environments enabling the support and conduct of clinical trials. The region houses competitive business operations; for example, Australia is ranked the second most competitive country in the world for business operations (KPMG, 2004).
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