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Wednesday, June 22 • 4:15pm - 5:15pm
#377: Choosing the Most Convincing Clinical Endpoints in Cancer Clinical Trials: How to Balance Different Perspectives?

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Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-645-L04-P ; CME 1.00; RN 1.00

The choice of endpoints for oncology trials requires balancing multiple and often competing objectives, like validity, feasibility, etc. In this session we’ll explore strategies for optimal endpoint selection from different perspectives.

Learning Objectives

Identify different estimands and attributes for efficacy endpoints in cancer clinical trials; Describe the different perspectives and trade-offs involved in the choice of endpoints; Discuss strategies for optimizing the choice of endpoint based on a survey of decision makers and examples of global cancer drug development.


Francesco Pignatti, MD


Results of the EMA Survey on PFS as a Clinical-Benefit Endpoint
Douwe Postmus, PhD, MSc

Endpoint Selection Strategies to Address the Needs of Multiple Decision Makers Globally
Amy McKee, MD

Trial Objectives and Endpoint Selection Considerations in the Cancer Drug Development
Rajeshwari Sridhara, PhD

avatar for Amy McKee

Amy McKee

CMO and Global Head, Oncology Center of Excellence, Parexel International, United States
Dr. McKee worked for over 10 years at the U.S. Food and Drug Administration most recently in the role of Deputy Center Director, Oncology Center of Excellence (OCE) and Supervisory Associate Director, OHOP, CDER. Dr. McKee was the signatory authority for products within Office of... Read More →
avatar for Francesco Pignatti

Francesco Pignatti

Scientific adviser for oncology, European Medicines Agency, Netherlands
Francesco Pignatti graduated as Medical Doctor at the University of Rome La Sapienza, Italy. In 1995 he became Research Fellow at the EORTC Data Center in Brussels, Belgium In 1997 he obtained a Master of Science degree in Biostatistics from the University of Limburg, Belgium. In... Read More →
avatar for Douwe Postmus

Douwe Postmus

Assistant Professor, Medical Statistics & Decision Making, Dept of Epidemiology, University Medical Center Groningen, Netherlands
Dr Douwe Postmus is employed as an assistant professor at the Department of Epidemiology of the University Medical Center Groningen, The Netherlands. His research focuses on applying quantitative modeling techniques to decision making problems in health care, including regulatory... Read More →
avatar for Rajeshwari Sridhara

Rajeshwari Sridhara

Senior Biostatistician Consultant, Oncology Center of Excellence, FDA, FDA, United States
Rajeshwari Sridhara, Ph.D. is the Division Director of Division of Biometrics V, Office of Biostatistics which supports Office of Hematology Oncology Products in the Oncology Center of Excellence and Center for Drug Evaluation and Research. As a leader in the field, she routinely... Read More →

Wednesday June 22, 2022 4:15pm - 5:15pm CDT
Room 470 B McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  11: Statistics, Session |   02: ClinTrials -ClinOps, Session |   05: Patient Engagement, Session