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Spoke 1: Defining the Clinical Trial Context of Use
Session Chair(s)
Ashley F. Slagle, PHD, MS
Principal, Scientific and Regulatory Consulting
Aspen Consulting, LLC, United States
Good measurement depends on a clearly defined context of use, including explicit consideration of the targeted disease definition, patient population, clinical trial design and objectives, clinical practice, and other aspects of the study setting.
Speaker(s)
Context of Use: An FDA Perspective
Ashley F. Slagle, PHD, MS
Aspen Consulting, LLC, United States
Principal, Scientific and Regulatory Consulting
Context of Use: Industry Perspective
Debra G. Silberg, MD, PHD
Shire Specialty Pharmaceuticals, United States
Senior Director, Clinical Development
Context of Use: Patient Advocate Perspective
Cynthia A Bens
Personalized Medicine Coalition, United States
Senior Vice President, Public Policy
Panel Discussion Moderator
Ashley F. Slagle, PHD, MS
Aspen Consulting, LLC, United States
Principal, Scientific and Regulatory Consulting
Panelists
Debra G. Silberg, MD, PHD
Shire Specialty Pharmaceuticals, United States
Senior Director, Clinical Development
Cynthia A Bens
Personalized Medicine Coalition, United States
Senior Vice President, Public Policy