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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
Principal, Scientific and Regulatory Consulting, Aspen Consulting, LLC, United States
Context of Use: Industry Perspective
Debra G. Silberg, MD, PhD
Senior Director, Clinical Development, Shire Specialty Pharmaceuticals, United States
Context of Use: Patient Advocate Perspective
Cynthia A Bens
Senior Vice President, Public Policy, Personalized Medicine Coalition, United States
Panel Discussion Moderator
Ashley F. Slagle, PhD, MS
Principal, Scientific and Regulatory Consulting, Aspen Consulting, LLC, United States
Panelists
Debra G. Silberg, MD, PhD
Senior Director, Clinical Development, Shire Specialty Pharmaceuticals, United States
Cynthia A Bens
Senior Vice President, Public Policy, Personalized Medicine Coalition, United States
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