Improving clinical trial sampling for future research - an international approach: outcomes and next steps from the DIA future use sampling workshop 2011.

PHARMACOGENOMICS(2013)

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摘要
Clinical trial samples collected for pharmacogenomic and future research are vital resources for the development of safe and effective drugs, yet collecting adequate, representative sample sets in global trials is challenging. The Drug Information Association (DIA) sponsored a workshop on future use sampling in September 2011, bringing together experts from regulatory agencies, academia and industry to discuss challenges to future use sample collection and identify actions to improve collection. Several common themes and associated action items emerged, including the need for international guidance on the collection of samples for future research; additional discussion related to coding, scope of research, and return of research results; and additional education about pharmacogenomic/future research and the importance of long-term storage of specimens.
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关键词
clinical trials,data privacy,drug development,EU EMA,future use sampling,Japan PMDA,pharmacogenetics,pharmacogenomics,regulatory agencies,US FDA
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