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Bethesda North Marriott Hotel and Conference Center

23 abr 2018 1:00 p.m. - 25 abr 2018 4:15 p.m.

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

DIA/FDA Biostatistics Industry and Regulator Forum

Session 2: Complex Innovative Designs

Session Chair(s)

Min  Lin, MD, PhD

Min Lin, MD, PhD

Statistical Science Director

Astrazeneca, United States

Amy  Xia, PhD

Amy Xia, PhD

Vice President, Center for Design and Analysis

Amgen Inc., United States

Both the 21st Century Cures Act and the PDUFA VI legislations emphasize on complex innovative designs, which require simulations to understand the design operating characteristics, statistical properties, and operational features. This session will review and discuss the issues related to any complex trial design that we need to simulate the trial to understand its full behavior. Additionally, it will discuss analyses that are complex enough so that we likely need simulation for deeper understanding of the models. Examples of complex analyses include using hierarchical analyses and historical data will be given. A group of speakers and panelists will discuss opportunities and challenges relative to complex innovative designs and analyses in medical product development.

Learning Objective : At the conclusion of this session, participants should be able to:
  • Discuss the role of simulation in complex innovative designs and analyses
  • Discuss case studies in complex innovative designs and analyses
  • Describe challenges and opportunities in complex innovative designs and analyses

Speaker(s)

John  Scott, PhD, MA

Simulations for Clinical Trial Operating Characteristics

John Scott, PhD, MA

FDA, United States

Division Director, Office of Biostatistics, CBER

Scott  Berry, PhD

Complex Clinical Trials: Design and Analysis

Scott Berry, PhD

Berry Consultants LLC, United States

President and Senior Statistical Scientist

Brian  Hobbs, PhD

Panelist

Brian Hobbs, PhD

The University of Texas at Austin Dell Medical School, United States

Associate Professor

Karen Lynn Price, PhD

Panelist

Karen Lynn Price, PhD

Eli Lilly and Company, United States

Senior Research Fellow, Statistical Innovation Center/Design Hub

Estelle  Russek-Cohen, PhD

Panelist

Estelle Russek-Cohen, PhD

FDA, United States

Senior Advisor, Office of Biostat

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