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Group Name
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ASA Biopharmaceutical Safety Working Group
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Contact/ Chairs
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Qi Jiang (Amgen) & Olga Marchenko (Quintiles)
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Contact email
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qjiang@amgen.com; olga.marchenko@quintiles.com
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Members
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- Christy Chuang-Stein (Pfizer);
- Chunlei Ke (Amgen);
- Mark Levenson (FDA)
- Haijun Ma (Amgen);
- Jeff Maca (Quintiles);
- Estelle Russek-Cohen (FDA);
- Matilde Sanchez (Arena Pharmaceuticals);
- Richard Zink (JMP Life Sciences, SAS Institute Inc).
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Objectives
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- Encourage increased use of systematic safety assessment approaches
- Where appropriate, develop new methods to address the existing safety challenges
- Educate the broader statistical community to understand and contribute to this important area
- Increase statisticians’ leadership roles in cross-functional collaboration
- Communicate statistical perspectives to larger clinical trial community
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Key achievements in 2014
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- Poster at the DIA/ FDA Statistics Forum (April, 2014);
- Session at Trends and Innovations in Clinical Trial Statistics conference (April, 2014);
- Session/ invited panel at SCT/ QSPI conference (December, 2015);
- Review paper “Evaluation and Review of Strategies to Access Cardiovascular Risk in Clinical Trials in Patients with Type 2 Diabetes Mellitus” was submitted to Statistics in Biopharmaceutical Research journal in November, 2014.
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Plans/events for 2015
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- Invited session/ panel at SCT annual conference (May, 2015) - accepted;
- Invited session at ISBS conference (June, 2015) - accepted;
- Invited session/ panel at the JSM (August, 2015) - accepted;
- Session/ panel at the FDA Industry Workshop (September, 2015) – accepted;
- Work on methodological paper on safety problems/ issues that require multiplicity adjustments/ strategy considerations (some with applications to CVOTs);
- To work on educational material/establish a library on safety statistics for ASA BIOP Section members.
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Workstream/
subgroups
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- Will be established in 2015
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Group resources
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- Chakravarty A. et al. “Evaluation and Review of Strategies to Access Cardiovascular Risk in Clinical Trials in Patients with Type 2 Diabetes Mellitus” (under SBR review)
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Keywords
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Safety statistics, safety analysis, safety monitoring, CVOT
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