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Implications for the design and interpretation of Phase III clinical trials

  • Luc Balant
  • Marianne Gex-Fabry
  • Androniki Balant-Gorgia
Part of the CMR Workshop Series book series (CMRW)

Summary

  1. 1.

    This paper discusses some methodological aspects introduced by new approaches to the conduct of Phase IIb and Phase III clinical trials in the context of inter-ethnic differences in drug behaviour, tolerance and response.

     
  2. 2.

    If a new chemical entity is intended to be used in different ethnic settings, the implementation of population approaches such as the pharmacokinetic screen or population kinetic models might be a cost-effective means of detecting inter-ethnic differences in drug effects.

     
  3. 3.

    Randomised concentration-controlled or concentration-monitored clinical trials can be adapted to the problems raised by new drug development in different ethnic groups. Although the implementation of the former may be premature, most of the elements necessary to perform the latter are current practice.

     
  4. 4.

    In addition to data analysis strategies, many unresolved issues remain to be clarified if large scale clinical trials are to be performed in multi-ethnic settings. These relate to pharmaco-geography, protocols and research instruments, biological data and regulatory aspects. However, common sense and scientific ethics will be more important than strict adherence to guidelines.

     

Keywords

Population Pharmacokinetic Large Scale Clinical Trial Data Analysis Strategy Nonlinear Mixed Effect Model Ethnic Factor 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

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Copyright information

© Springer Science+Business Media Dordrecht 1994

Authors and Affiliations

  • Luc Balant
  • Marianne Gex-Fabry
  • Androniki Balant-Gorgia

There are no affiliations available

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