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Legend: Boston Convention & Exhibition Center = CC, Westin Boston Waterfront = W, Seaport Boston Hotel = S
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225 * Mon, 8/4/2014, 2:00 PM - 3:50 PM CC-252B
Strategies to Mitigate Against Operational Bias in Adaptive Designs for Medical Device Trials — Topic Contributed Papers
Section on Medical Devices and Diagnostics , Section on Physical and Engineering Sciences
Organizer(s): Greg Maislin, Biomedical Statistical Consulting
Chair(s): Greg Maislin, Biomedical Statistical Consulting   
2:05 PM Strategies to Mitigate Against Operational Bias in Adaptive Designs for Medical Device Trials Caroline Morgan, Cytel
2:25 PM The Use of 'Fuzzy Promising Zones' to Mitigate Against Operational Bias in Adaptive Sample Size Re-Estimation Designs Brendan Keenan, Biomedical Statistical Consulting ; Greg Maislin, Biomedical Statistical Consulting
2:45 PM Operational Bias in Adaptive Designs: Potential Sources and Mitigation Strategies Michelle Detry, Berry Consultants
3:05 PM Mitigating Operational Bias in Adaptive Design: A Regulatory Perspective Martin Ho, FDA
3:25 PM Discussant: Charity Morgan, University of Alabama at Birmingham
3:45 PM Floor Discussion



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