The Relevance of Ethnic Factors in the Clinical Evaluation of Medicines : Medicines

Reviews the current situation in clinical evaluation and addresses the scientific basis for repeating trials in different ethnic groups. Specific examples are considered and assessments made of the relevance of inter-ethnic and environmental differences in responsiveness for drug development

I. Problems in the Acceptability of Foreign Clinical Data for Pharmaceuticals.- 1 Acceptability of foreign data: genetic, cultural and environmental differences - do they matter?.- 2 Genetic polymorphisms in drug metabolism: clinical implications and consequences in ADME studies.- 3 Inter-ethnic differences in dose-response studies.- 4 Evaluation methods for clinical trials of drugs in Japan which may affect ethnic differences.- 5 The top 50 drugs in the UK and Japan: why are they so different?.- 6 Ethnic differences in response to pharmaceuticals across Europe.- 7 Medical practice differences between Europe, the United States and Japan.- 8 A survey of current practices in the US regarding minorities and gender: the pharmaceutical perspective.- 9 Current approaches to global drug development from a European perspective.- 10 Current approaches to global drug development from a Japanese perspective.- 11 Summary of Session I.- II. The Relevance of Ethnic Factors in the Clinical Evaluation of Medicines.- 12 The acceptability of foreign data in the registration of new medicines - Health Protection Branch viewpoint.- 13 The acceptability of foreign data in the registration of new medicines.- 14 Ethnic effects on pharmacokinetic parameters.- 15 A comparison of the clinical evaluation of medicines in Japanese and Caucasian populations.- 16 Current status of CMR survey on inter-ethnic differences in clinical responsiveness.- III. The Relevance of Inter-Ethnic Differences for Drug Development and Registration.- 17 Implications for the design and interpretation of Phase III clinical trials.- 18 Dose-utility relationships in diverse populations: ethnic, age, gender and cultural factors in efficacy and safety.- 19 General discussion and concluding remarks.- Appendix - Workshop participants.