Enabling pharmacogenomic clinical trials through sampling

Discussion and output from the US FDA and the pharmaceutical industry from the Drug Information Association/FDA 5th Workshop in a series on pharmacogenomics entitled: 'Generating and Weighing Evidence in Drug Development and Regulatory Decision Making . A major topic area at the 5th FDA/Industr...

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Bibliographic Details
Published inPharmacogenomics Vol. 11; no. 12; pp. 1649 - 1654
Main Authors Warner, Amelia, Nelsen, Anita, Bhathena, Anahita, FitzGerald, Kevin, Gilardi, Sandra, Kelso, Ellen, Knoppers, Bartha, McLeod, Howard L, Nelson, Robert, Uyama, Yoshi, Weisman, Jennifer, Rudman, Allen
Format Journal Article Conference Proceeding
LanguageEnglish
Published England Future Medicine Ltd 01.12.2010
Subjects
Analysis
Clinical trials
Clinical Trials as Topic - legislation & jurisprudence
Clinical Trials as Topic - methods
Clinical Trials as Topic - standards
Drug Design
drug development
Drug Industry - standards
Government Regulation
International Cooperation
international coordination
Pharmaceutical industry
Pharmacogenetics
pharmacogenomics
Product development
regulatory
sample collection
Sampling Studies
United States
United States Food and Drug Administration
United States
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Summary:Discussion and output from the US FDA and the pharmaceutical industry from the Drug Information Association/FDA 5th Workshop in a series on pharmacogenomics entitled: 'Generating and Weighing Evidence in Drug Development and Regulatory Decision Making . A major topic area at the 5th FDA/Industry Workshop on Pharmacogenomics, February 2-4, 2010 in Bethseda (MD, USA), was enabling pharmacogenomic clinical trials through collection of future use samples. The importance of the collection of samples with permission for future analyses was affirmed by both industry and the FDA. In addition, current barriers for the collection of such samples were detailed and possible solutions for overcoming barriers at sites, as well as globally within countries, were discussed. The importance of international concordance on collection of these samples was emphasized, and potential areas for industry to harmonize sample collection practices. A standalone workshop on issues related to sampling was determined to be a key step for solving issues related to future use sample collection during drug development.
Bibliography:ObjectType-Conference-1
SourceType-Conference Papers & Proceedings-1
content type line 25
ISSN:1462-2416
1744-8042
DOI:10.2217/pgs.10.139