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Innovations in the Science and Practice of Clinical Trials Present

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Innovations in the Science and Practice of Clinical Trials Present
FDA & SCT/QSPI* Present
Innovations in the Science and Practice of Clinical Trials
December 9-10, 2014
Universities at Shady Grove Conference Center, Rockville, Maryland
FEATURED SPEAKERS
PROGRAM CO-CHAIRS
Mike Hale
Amgen
John Scott
Theresa Mullin
FDA/CDER
Jesse Berlin
Janssen R&D
Petra Kaufmann
NIH/NCATS
Alex Dmitrienko
Quintiles
Michelle McMurry-Heath
FDA/CDRH
Steve Snapinn
Amgen
Bob Stone
Medical Design Solutions
Butch Tsiatis
North Carolina State Univ.
Janet Wittes
Statistics Collaborative
FDA/CBER
PROGRAM COMMITTEE
Patrick Archdeacon
FDA/CDER
Janelle Charles
FDA/CDER
Dixie J Ecklund
University of Iowa
Martin Ho
FDA/CDRH
Qi Jiang
Amgen
Olga Marchenko
Quintiles
Daniel J. Sargent
Mayo Clinic
David Stock
Bristol-Myers Squibb
Pamela Tenaerts
Duke Translational
Research Institute
Marc Walton
Janssen R&D
This multi-disciplinary workshop brings together thought leaders from the
FDA, industry, academia and patient groups for direct and open discussions on
recent innovations in the science and practice of clinical trials.
Day 1: Innovation in Clinical Trial Design, Analysis, and Operations
Session 1: Clinical Trial Design and Analysis
 Rare Diseases & Small Trials
 Rare Events & Large Trials
Session 2: Streamlining Clinical Trial Operations
 Central IRBs and Master Clinical Trial Agreements
 Wearable Devices for Clinical Trials
Conference Information Day 2: Incorporating Broader Experiences & Information in Clinical Trials
Session 3: Patient Partnerships in Clinical Trial Design and Conduct
and Registration:
 Patient Group Engagement in Clinical Trials
meeting.sctweb.org/qspi

Incorporating Patient Preferences into Regulatory Decision-Making
Session 4: Leveraging Diverse Data Sources in Planning, Analysis and Interpretation
 Data Transparency / Shared Data
 Administrative Claims Databases

Product Life-Cycle Safety Data Synthesis
* Conference is sponsored by the Food and Drug Administration (FDA), and the Society for Clinical Trials (SCT). QSPI (Quantitative Sciences in the
Pharmaceutical Industry) is a committee of the SCT.
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