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KMID : 1142220140090020149
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Regulatory Research on Food, Drug & Cosmetic
2014 Volume.9 No. 2 p.149 ~ p.157
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Investigation on Multi-Regional Clinical Trial (MRCT)
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Yang Hyun-Ju
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Abstract
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A multi-Regional clinical trial is defined as the clinical trial which is conducted simultaneously in two and more regions with one common protocol. Here, the region should not be defined as geographic boundaries only. The systemic approach is required to define regions by considering intrinsic and extrinsic factors in the planning stage of clinical trial. The purposes of conducting clinical trial in multi-regions are to develop a drug simultaneously, to shorten the overall clinical trial period through efficient subject recruitment, to utilize it as bridging data, and so on. According to the FDA OIG(Office of Inspector General) and EMA(European Medicinal Agency) reports, the clinical trial data which were submitted to US and Europe for MAA(Market Authorization Application) approval contains foreign data as certain portion, and this trend is being increased continuously. The multi-regional clinical trial has been gradually increased in Korea since IND(Investigational New Drug) became separated from NDA(New Drug Application) in 2002. The number of multi-regional clinical trials in Korea was decreased since 2009 due to the investment decrease in pharmaceutical industry caused by the global economic crisis but was sharply increased again in 2012. Then, it showed slight decrease in 2013 but Korea was ranked at 7th grade globally in terms of number of clinical trial, according to the data in ClinicalTrial.gov registry. Under this global and domestic situation, some points to consider on the planning of multi-regional clinical trial were investigated from the aspect of country selection, investigational site/investigator selection and subject recruitment. Firstly, the appropriate countries including suitable number of countries should be decided by taking into consideration of several factors such as epidemiology data, regulatory requirement, subject recruitment rate and its trend, experience of investigators, medical practice, availability of comparator or feasibility of placebo, ethical and social consideration, competitive clinical trial, and so on. Secondly, the investigational site and investigators should be selected based on the assessment of the interest on the clinical trial, availability of eligible subjects and suitable number of subjects, resources and facility in the investigational site, qualified investigators and their experience on the clinical trial, existence of qualified staff, geographical location, review timing of Institutional Review Board and its management, historical information in the regulatory authority (e.g. FDA audits, “blacklist”), and so on. Finally, as the subject recruitment is the biggest cause of delaying overall clinical trial, it is important to make a subject recruitment strategy including advertisement, use of database, persistent subject recruitment tool, and way to sustain motivation to recruit subjects by staff, at the clinical trial planning stage and to continue to implement them by the end of clinical trial. Among the 3 axis, quality, time and cost, for the success of clinical trial, shortening the drug development time from the time axis will contribute to the early access of new drug to the patients.
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KEYWORD
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Multi-national clinical trial, Multi-Regional Clinical Trial
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