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.