Analysis of the Current State of Industry-Sponsored Global Clinical Trials in Asia
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ORIGINAL RESEARCH ARTICLE
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Analysis of the Current State of Industry-Sponsored Global Clinical Trials in Asia Discussion in Terms of Study Designs and Target Diseases Soichiro Muroyama, Mamoru Narukawa and Masahiro Takeuchi Department of Clinical Medicine (Pharmaceutical Medicine), School of Pharmacy, Kitasato University, Tokyo, Japan
Abstract
Background: The number of industry-sponsored global clinical trials conducted in Asian countries has been increasing in recent years as part of the global development of new drugs. A successful global clinical trial in Asia depends on formulating a development strategy based on a thorough understanding of the preceding study results and the characteristics of individual countries within the region. In addition, large population sizes and the simple constitution of ethnicity that is seen in all Asian countries are a great advantage to achieve an adequate sample size and shorten the study period. The purpose of this paper is to analyse the current state of industry-sponsored global clinical trials in Asian countries. Methods: Clinical trial information was compiled by extracting relevant information from ClinicalTrials.gov to create a secondary database of all industry-sponsored, phase II and III studies that involved two of more Asian countries. Country-specific analyses were conducted for study design (e.g. type, phase, target sample size, sponsor’s nationality, and time of commencement), therapeutic area and target disease. Results: The majority of global clinical trials involving Asian countries were confirmatory in nature, as shown by their basic study designs and study phases; however, exploratory studies are more common than confirmatory studies in Japan and Singapore. The most common target disease was non-small-cell lung cancer, followed by breast cancer, bipolar disorder, type 2 diabetes mellitus and hepatitis B. Industry-sponsored global clinical trials in Asia covered a variety of therapeutic areas; however, therapeutic areas vary greatly among countries. Cardiovascular diseases ranked highly in China, and HIV infections ranked first in Thailand. Conclusion: Differences in study designs observed across the Asian region may reflect country-specific characteristics; for example, Singapore is actively inviting early phase clinical studies, while Japan has been originating a number of new drugs. Industry-sponsored global clinical trials in Asia have recently covered a variety of therapeutic areas. There are, however, some different trends in the target diseases among different countries. It is thus crucial to consider these trends when selecting study areas and formulating a development strategy, to conduct a global clinical trial in Asian countries more efficiently and effectively.
Background In recent years, new drug development has been globalized. Clinical trials have been frequently conducted not only in Western countries but also in Asian countries. At the same time, the environment surrounding the pharmace
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