The Relevance of Ethnic Factors in the Clinical Evaluation of Medicines : Proceedings of a Workshop Held at The Medical Society of London, UK, 7th and 8th July, 1993

For a research-based pharmaceutical company to be successful in the 1990s. it must have a strategic plan for the global development of new chemical entities. Global development can be defined as an attempt to reach all major markets as rapidly as possible and for many companies these will include the United States. Japan. Germany. France. Italy. UK and Canada. which together represent approximately 85% of the pharmaceutical market in the developed world. The mutual acceptance of foreign clinical data would reduce the time and resources required to develop a new medicine for the international market by eliminating the requirement for the routine repetition of clinical studies in local populations. In Japan this has been largely based on the belief that genetic differences in respon­ siveness may result in a different benefit/risk assessment for a new mediCine. while requests in Europe and the United States for local data relate mainly to methodological and cultural considerations. The importance of this issue has been recognised internationally as it was one of the topics discussed at the International Conference on Harmonisation in Orlando (October 1993) and it is currently on the programme for ICH3 which will be convened in Yokohama in Japan in November 1995. Front Matter....Pages i-xviii Front Matter....Pages 1-1 Acceptability of foreign data: genetic, cultural and environmental differences - do they matter?....Pages 3-11 Genetic polymorphisms in drug metabolism: clinical implications and consequences in ADME studies....Pages 13-26 Inter-ethnic differences in dose-response studies....Pages 27-48 Evaluation methods for clinical trials of drugs in Japan which may affect ethnic differences....Pages 49-62 The top 50 drugs in the UK and Japan: why are they so different?....Pages 63-88 Ethnic differences in response to pharmaceuticals across Europe....Pages 89-96 Medical practice differences between Europe, the United States and Japan....Pages 97-106 A survey of current practices in the US regarding minorities and gender: the pharmaceutical perspective....Pages 107-114 Current approaches to global drug development from a European perspective....Pages 115-130 Current approaches to global drug development from a Japanese perspective....Pages 131-138 Summary of Session I....Pages 139-143 Front Matter....Pages 145-145 The acceptability of foreign data in the registration of new medicines - Health Protection Branch viewpoint....Pages 147-154 The acceptability of foreign data in the registration of new medicines....Pages 155-159 Ethnic effects on pharmacokinetic parameters....Pages 161-177 A comparison of the clinical evaluation of medicines in Japanese and Caucasian populations....Pages 179-186 Current status of CMR survey on inter-ethnic differences in clinical responsiveness....Pages 187-197 Front Matter....Pages 199-199 Implications for the design and interpretation of Phase III clinical trials....Pages 201-217 Dose-utility relationships in diverse populations: ethnic, age, gender and cultural factors in efficacy and safety....Pages 219-227 General discussion and concluding remarks....Pages 229-251 Back Matter....Pages 253-262 There is currently limited acceptance of foreign clinical data by regulatory authorities, although the reasons for repeating studies are poorly defined. There are some proven genetic differences in drug metabolism and elimination which occur with varying frequencies in different populations. In addition, there are differences in culture, environment and medical practice which can impact on drug reponsiveness. This book, a further edition in the CMR Workshop Series, reviews the proceedings of a workshop held in London in July 1993 to address these issues. The contributors review the current situation, address the scientific basis for repeating clinical trials in different ethnic groups, consider specific examples, and assess the relevance of interethnic and environmental differences in responsiveness for drug development.