Forget China And India, Clinical Trial Opportunities In Malaysia and South Korea
This article was originally published in PharmAsia News
Executive Summary
The opportunities for clinical trials in China and India are well known to the pharmaceutical industry at this point, but Edward Ian, senior director of clinical operations for PRA International-Asia Pacific, wants company leaders to take notice and advantage of the potential in other countries in Asia Pacific
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The opportunities for clinical trials in China and India are well known to the pharmaceutical industry at this point, but Edward Ian, senior director of clinical operations for PRA International-Asia Pacific, wants company leaders to take notice and advantage of the potential in other countries in Asia Pacific. Discussing the clinical trial milieu in a Sept. 2 webinar, Ian highlighted the progress being made in Malaysia and South Korea, two countries that previously may not have garnered the same amount of attention as China and India. "Malaysia is a country I would highly recommend for global studies," Ian said, citing the prevalence of English speakers (it's one of the country's official languages) and the country's well-established clinical research infrastructure. Malaysia's Ministry of Health established the Clinical Research Center in 2000, which acts as a "one-stop" center for industry and research institutes to access to the ministry's network of 17 clinical research centers. "My experience working with the CRC and their one-stop center has been nothing but positive. There is a clinical investigator register that is implemented and managed by the government. There are currently 4,555 investigators listed. Their names, titles, institutions, specialties and GCP certification status are all listed. To me, that is simply amazing," Ian said. The PRA official also touted South Korea as a "major attraction in Asia to support Phase I trials … for two major reasons: superb infrastructure at the study sites and dedicated and committed investigators." PRA opened its first office in Seoul in July, hoping to capitalize on the country's efforts to ramp up its clinical trial infrastructure (Also see "As Korea Steps Up Drive To Attract Global Clinical Trials, American CRO Opens Outpost In Seoul" - Scrip, 27 Jul, 2009.). Since the country cannot compete with the large patient populations in India and China, South Korea is hoping to top Singapore to become the regional leader for Phase I and Phase II trials (Also see "South Korea Beefs Up Infrastructure To Lead Asia In Early-Stage Clinical Trials" - Scrip, 12 Feb, 2009.). Japan and Pan-Asian Trials Countries like Singapore, South Korea and Malaysia have been drawing more interest from companies expanding global trials to accelerate clinical trial work, including from Japan. Japanese companies have spread across Asia, looking to overcome Japan's long approval periods, slow patient enrollment and high trial costs (Also see "Japanese Pharma Looking Beyond Japan For Clinical Trials" - Scrip, 10 Apr, 2008.). [Editor's note: PharmAsia News talked with Satoshi Matsumoto, clinical research executive director of Japanese CRO Shin Nippon Biomedical Laboratories, about Japan's clinical trial drain (Also see "Japanese CRO SNBL's Satoshi Matsumoto On Japan's Clinical Trial Drain: An Interview with PharmAsia News" - Scrip, 8 Jul, 2009.).] As it becomes harder to fully enroll trials in the country, Japan's PMDA is becoming more open to accepting study data generated in neighboring countries, according to Ian. "The practice of pan-Asian clinical study is expected to have a positive impact to the clinical research in industry in Asia," Ian said. In particular, Japan has decided a Phase I trial inside the country may not be necessary for approval if safety and dosage levels can be determined from foreign Phase I trial results. While regulatory change occurs slowly in Japan, PMDA's movement to streamline global clinical trials began after the issuance of "Basic Principles on Global Clinical Trials", in which the agency set forth guidelines for conducting simultaneous global trials (Also see "New Japanese Global Clinical Trial Requirements Could Help MNCs – BIO-Asia Panel" - Scrip, 5 Feb, 2008.). China, Japan and Korea have also formed the Regional Harmonization Initiative to address clinical data sharing to achieve harmonization and reduce duplication. Part of the initiative is the study of pharmacogenomic factors that single out Chinese, Korean and Japanese genetic variances from Caucasians. Such studies have enabled Japan to move toward accepting data from other countries in lieu of data from Japanese trials (Also see "Regulatory Harmonization Takes Center Stage At IFPMA Asia Event" - Scrip, 13 Mar, 2008.). - Daniel Poppy ([email protected]) |