Clinical Trials in Southeast Asia: An Update
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Clinical Trials in Southeast Asia: An Update Ellick Wong, PhD Adjunct Professor. National University of Singapore, Singapore
Key Words Clinical trial; Southeast Asia: SWOT analysis
Correspondence Address Ellick Wong. PhD, Adjunct Professor. National University of Singapore. 18 Science Drive 4. Singapore 117543 (ernail: [email protected]).
INTRODUCTION: GLOBAL DRUG DEVELOPMENT The pharmaceutical industry is facing intense challenges not unlike a storm. Research-based pharmaceutical companies need to make considerable changes to counteract the negative impacts from patent expirations and generic competition, increasing R&D costs but falling productivity, pricing pressures, and hostile regulatory environments to ensure future success. To improve R&D productivity, many major US and European pharmaceutical companies have adopted global drug development and outsourcing strategies that extend their clinical trial activities to destinations that include emerging markets expecting faster patient recruitment and potential cost savings. The globalization movement has let Tufts University regulatory scientists predict that within two to three years, up to 65% of FDA-regulated clinical trials for top pharmaceutical companies will be conducted outside the United States (1). Emerging markets have already played a significant role in pharmaceutical sales: their strong growth is projected to continue at rates that will outpace those of the developed markets. It is foreseeable that the shift in market dynamism in favor of the emerging markets, particularly in Asia, will further promote the placement of trials in the Asian region.
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In recentyears, the environment and infrastructure available for conducting clinical trials in Southeast Asia have improved. The region has attracted an increasing number of drug development trials h m US and European sponsors. Luteb some Japanese pharmaceutical companies have begun to conduct Pan-Asian multicenter trials involving some Southeast Asian countries. It is expected that the globalization movement in drug development and the emerging trend of Pan-Asian trials will create increasing demands on Southeast Asian sites and fuel the growth of the clinical trial market in the region.
In the past couple of years, the Japanese drug regulatory authority has started to be somewhat more open to accepting foreign data for drug approval. The new stance has encouraged an increasing number of Japanese pharmaceutical companies to broaden their drug development programs to be conducted beyond their home territory. There is an emerging trend of so-called Pan-Asian multicenter trials being performed, involving Japanese clinical trial sites and other sites in Asian countries outside Japan.
THE STRONG GROWTH O F CLINICAL TRIALS I N SOUTHEAST ASIA The globalization movement in drug development and the emerging trend of Pan-Asian trials are expected to place increasing demands on Asian sites and fuel the growth of the clinical trial market in Southeast Asia. Within the region, Singapore, Hong Kong, and T
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