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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 inter-ethnic and
environmental differences in responsiveness for drug development.
At a time when it is becoming usual for medicines to be developed
for a global market and pharmaceutical companies are endeavouring
to expedite the drug development process, Regulatory authorities
are concentrating on improving their efficiency and effectiveness.
Therefore, it is not surprising that questions are being asked as
to how performance might be measured and compared between different
authorities who are now often in receipt of dossiers that have been
submitted to several agencies at the same time. Issues such as
"what target should be set for the review of new medicines?" and
"how can quality be assured?" are now considered to be of critical
importance. The 12th CMR International Workshop, held in January
1997, provided the opportunity for regulatory authority and
industry personnel from Europe, North America, Australia and Japan
to openly discuss experiences and exchange views on how to improve
the review process. The proceedings of this meeting provide a
comprehensive overview of the current review process in different
countries and the need for performance measures and targets. This
volume summarizes the many suggestions that were debated at the
workshop, and includes chapters on measuring performance, and on
the integration of quality into the review process.
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