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

Amelia Wall Warner; Karina L. Bienfait; Marianna Bledsoe; Gilbert Burckart; Bruno Flamion; Bartha Knoppers; Anita J. Nelsen; Allen Rudman; Nicole J. Sieffert; Yoshiaki Uyama

doi:10.2217/pgs.12.193

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

Amelia Wall Warner, Karina L. Bienfait, Marianna Bledsoe, Gilbert Burckart, Bruno Flamion, Bartha Knoppers, Anita J. Nelsen, Allen Rudman, Nicole J. Sieffert, Yoshiaki Uyama

Research output: Contribution to journal › Article › peer-review

Abstract

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.

Original language	English
Pages (from-to)	103-112
Number of pages	10
Journal	Pharmacogenomics
Volume	14
Issue number	1
DOIs	https://doi.org/10.2217/pgs.12.193
Publication status	Published - 1 Jan 2013

Keywords

clinical trials
data privacy
drug development
EU EMA
future use sampling
Japan PMDA
pharmacogenetics
pharmacogenomics
regulatory agencies
US FDA

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10.2217/pgs.12.193

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Warner, A. W., Bienfait, K. L., Bledsoe, M., Burckart, G., Flamion, B., Knoppers, B., Nelsen, A. J., Rudman, A., Sieffert, N. J., & Uyama, Y. (2013). Improving clinical trial sampling for future research-an international approach: Outcomes and next steps from the DIA future use sampling workshop 2011. Pharmacogenomics, 14(1), 103-112. https://doi.org/10.2217/pgs.12.193

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

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Keywords

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