Simplified Controlled Studies in New Regions for Safety Concern Arising From Using Foreign Safety Data
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Simplified Controlled Studies in New Regions for Safety Concern Arising From Using Foreign Safety Data Yeong-L1ang Lin, MD
Reviewer, Center for Drug Evaluation. Taiwan. ROC
Chlen-Hua Wu, PhD
Assistant Professor, Department of Applied Mathematics. Chung-Yuan Christian University. Taiwan, ROC
K. Arnold Chan, MD, ScD
Adjunct Associate Professor, Department of Epidemiology, Harvard School of Public Health. Boston, Massachusetts, USA
Key Words
lCH; E5; Ethnic factor; Hepatic; Safety
Correspondence Address
Yeong-Liang Lin, MD. Center for Drug Evaluation. 1F, No. 15-1, Section 1, Hangjou S Road, Taipei, Taiwan 100 (e-mail: [email protected]).
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To expedite the introduction of new medications and to minimize duplication of clinical trials, many Asian countries have implemented the International Conference on Harmonisationguideline £5, Ethnic Factors in the Acceptability of Foreign Clinical Data, to replace local registration trials before marketing approval of new drugs intheir populations. The evaluation, according to the £5 guideline, may determine that direct extrapolation of foreign safety data to the new region is not appropriate. Under such circumstances, bridging studies in the new region are required to generate region-specific safety information to address
INTRODUCTION Facing increasing pressure to rapidly introduce new drugs that have proved to be efficacious and safe in foreign countries, several Asian countries have enthusiastically implemented the International Conference on Harmonisation guideline ES, Ethnic Factors in theAcceptability of Foreign Clinical Data, to assess the acceptability of extrapolation of foreign efficacy and safety data to their populations in hopes that duplication of clinical trials can be minimized and patients can benefit from powerful new drugs without unnecessary delay (1-4). Although some controversies regarding this guideline remain to be clarified (eg, which studies should be conducted if the assessment determines that direct extrapolation of foreign safety data to the new population is not appropriate), this assessment is a feasible approach to reduce the number of clinical trials required for registration purposes in these countries. According to ES, if a drug is evaluated to be sensitive to ethnic differences in terms of efficacy or safety. a variety of types of studies can be conducted to address the efficacy or safety con-
potential safety concerns. The present article discusses how safety studies in the new regions addressing safety concern arising from using foreign data may be designed, and we usehepaticsafety asan example. The discussions focus on desirable types of thestudies, the timing for conducting such studies, the appropriate endpoints and controls, the optimal studyduration, and the populations to be studied. By addressing these key design issues, we hope that the results generated by these safety studies can provide adequate race- and population-specific evidence to support the approval of new drugs in the new region.
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