Ten-year Experience of the Evaluation of Ethnic Sensitivity Data

Because ethnic factors may affect a drug's efficacy and safety, bridging study evaluations (BSEs) were introduced in 2001 to assess the suitability of extrapolating foreign data during registration of a drug in Taiwan. The BSE program, based on the International Conference on Harmonization E5 guideline, may allow further clinical trials to be waived if favorable safety and extrapolation data are presented by the drug sponsor. For this study, 366 cases were collected, grouped according to categories and analyzed for rate of successful bridging study waivers. We defined one drug as one case regardless of the number of BSE submissions, and determined the rate of overall bridging study waivers to be 73.8%. The percentage of waivers in each category was studied. Several reasons for unsuccessful first-submission BSE waivers were indentified. Complete clinical data containing Asian pharmacokinetic data and clinical efficacy data were present in many successful bridging studies. Under some conditions, it is satisfactory that ethnic concerns for safety and efficacy might be answered by a phase 4 study.