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Representing more than a third of the world’s population, the Asia-Pacific is an attractive option for cost-effective clinical research regardless of whether the target market for the product is within or outside the region. However, if the clinical research is not conducted efficiently, or to an appropriate level of quality, the anticipated savings can in fact lead to costly mistakes. In this context, the first Partnerships in Clinical Trials Asia Pacific conference was successfully held in Singapore in December 2009. The two-day conference attracted many 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 key conference topics centered on the potential and the challenges of conducting clinical trials in the Asia Pacific region and establishing successful outsourcing partnerships with CROs. The conference included a particular focus on the conduct of clinical trials in China and India.
Emerging markets are playing an increasingly important role and this has been demonstrated by the 20% average annual growth rate of clinical trials in Asia. Ruiping Dong, MD, PhD, vice president of Global Development & Medical Affairs, Asia Pacific & Emerging Markets, Bristol-Myers Squibb, listed some of the pull factors for conducting clinical studies in Asia as large patient population, favorable R&D profile, and the growing pharmaceutical market.
Dr. Dong observed that Asia’s population presents an increased incidence of lifestyle diseases, demand for western medicines, and awareness of clinical trial participation benefits. At the same time, the presence of experienced investigators and world-class research facilities in Asia, alongside the registration requirement for Asian clinical data and the lower R&D costs all encourage running clinical trials in this region.
With more clinical trials being conducted in Asia, Sven Ohlman, MD, PhD, regional director of Clinical Study Operations Asia, AstraZeneca, highlighted a few challenges pharmaceutical and biotech companies might face and suggested some solutions. According to Dr. Ohlman, getting the global development strategy right for Asia with the aim to close the drug lag and avoid unnecessary additional local trials is an important challenge.
Markets such as China, Japan, Korea, and India require local Phase III data for marketing authorization and taking note of trends like the tripartite agreement between Japan, Korea, and China in global planning will ensure Asian success. To address the high costs of running clinical trials in Japan, it is pertinent to include Japan development in the core global program to avoid stand-alone development.
From a regulatory point of view, long approval times also pose a challenge to clinical trials in Asia. This is a particularly important issue in China. One way to reduce the impact of long approval times is to focus on large-scale late stage studies with fairly long recruitment periods, which gives the time for catch up.
Another challenge for Asia is to improve its perception in the West. One suggestion was to put priority on quality over time and costs and focus on getting quality done the right way.
With these challenges in mind, it might be beneficial to consider partnerships with CROs in Asia. Simon Britton, vice president, Clinical Development, Asia Pacific, PPD, presented his view that pharmaceutical and biotech companies should tap into the existing resources established by CROs. Outsourcing could provide valuable knowledge of local and global standards, local Asian language and unique cultural requirements thereby improving site oversight and adherence to protocols. At the same time, with outsourcing, the local expertise, whether at sites for specific study needs or for country-specific regulatory requirements could be made accessible quickly.
India and China
Mark Engel, president and CEO, Excel Pharmastudy, shared with delegates that expatriating profits in the form of clinical data was a feasible option for the large multinational sponsors with considerable profits from China. In this way, China profits were being reinvested in China R&D, reducing the exposure to the dividend taxes imposed under China tax law.
Deng Ya-Zhong, MD, vice president, Contract Research Organization Union, China, noted the trend for reducing regulatory approval timelines in China, the need to conduct trials in SFDA certified hospitals, Chinese culture of earning respect and trust as an important first step for establishing personal connections (or "Guanxi") and development of infrastructure as characteristic features and measures supportive of conducting clinical trials in China.
Y.K. Gupta, MD, head of the Deptartment of Pharmacology, All India Institute of Medical Sciences, and Coordinator, Zonal Pharmacovigilance Centre, India, highlighted some fundamental strengths of India for clinical trials, namely speed of patient recruitment, a 30% to 50% reduction in costs when compared to the United States or EU, a vast pool of treatment naive patients, presence of English speaking investigators, and the favorable regulatory environment. The disease pattern in India is also observed to be changing from that of diseases of developing countries to developed countries such as diabetes and cancer. The Indian clinical trial market is evolving with draft regulations coming up for biomedical devices, herbal remedies, stem cell research, and postmarketing surveillance and future central registry and monitoring body for ICH-GCP compliant ethics committees.
The conference ended with the delegates obtaining valuable insights to Asia and a better understanding of the rapidly evolving Asia Pacific region, including China and India, and the important role played by Asia in global clinical development.
May Ling Chan is a Consultant for Voisin Consulting in Singapore, and Stuart Mudge, PhD, is General Manager and Project Director for Voisin Consulting, Australia Pty Ltd.
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