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Advancing the Science of Study Endpoints

Session 6: Endpoint Evolution During Drug Development – Time to Deterioration Endpoint Case Study

Session Chair(s)

J. Jason Lundy, PhD

J. Jason Lundy, PhD

  • Principal
  • Outcometrix, United States

To sufficiently define a clinical trial endpoint, both a relevant clinical outcome and an appropriate statistical test are needed. In addition, the interpretation (or clinical meaningfulness) of that data also should be specified. This session will describe the distinction between outcomes and endpoints, and discuss the evolution of endpoints throughout the drug development lifecycle. Time to deterioration endpoints in oncology clinical trials will be used as a case-study to illustrate endpoint positioning and interpretation.

Learning Objective : Upon completion of this session, participants should be able to:
  • Describe the difference between outcome measures and endpoints
  • Formulate appropriate strategies to collect and analyze COA endpoint data
  • Apply the concept of symptom deterioration to the selection and positioning of clinical trial endpoints in chronic diseases (e.g., oncology)

Speaker(s)

Stephen Joel Coons, PhD

From Outcomes to Endpoints

Stephen Joel Coons, PhD

  • Executive Director, PRO Consortium
  • Critical Path Institute, United States
Lisa Kammerman, PhD, MS

Endpoint Selection and Positioning

Lisa Kammerman, PhD, MS

  • Regulatory Statistics and PRO Consultant
  • Kammerman Consulting, LLC, United States
Bellinda King-Kallimanis, PhD

Time to Deterioration Endpoints in Oncology Clinical Trials

Bellinda King-Kallimanis, PhD

  • Senior Staff Fellow, CDER, OHOP
  • FDA, United States
Paul Kluetz, MD

Time to Deterioration Endpoints in Oncology Clinical Trials

Paul Kluetz, MD

  • Associate Director for Patient Outcomes (Acting), OCE
  • FDA, United States
Jessica Roydhouse, PhD

Time to Deterioration Endpoints in Oncology Clinical Trials

Jessica Roydhouse, PhD

  • ORISE Fellow
  • FDA, United States

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