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Monday, June 28 • 2:30pm - 3:30pm
#130 SL: Real-World Response: Harnessing Electronic Health Records to Develop Robust Clinical Endpoints in Solid Tumors

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-537-L04-P; CME 1.00; IACET 1.00; RN 1.00

RECIST-based response is an established endpoint in clinical trials, but how do you assess response in routine patient care? This session presents efforts to develop a real-world response endpoint and its utility in clinical development.

Learning Objectives

Describe the utility of measuring treatment response in clinical trials and challenges of accessing it in routine clinical care; Discuss methods, data elements, and rigor needed to evaluate this endpoint and future implications for clinical development.


Michael W. Lu, PharmD


Real-World Response: Harnessing Electronic Health Records to Develop Robust Clinical Endpoints in Solid Tumors
Ariel Bourla, MD, PhD

Application of Real-World Response in Prospective Studies
Michael W. Lu, PharmD

Exploring Real-World Response and Progression Free Survival in the AACR GENIE Biopharma Collaborative
Gregory Riely, MD, PhD

avatar for Michael Lu

Michael Lu

Platform Strategy Leader, RWD, Personalized Healthcare Oncology, Genentech, A Member of the Roche Group, United States
Michael Lu serves as a Real World Data Platform Strategy Leader at Genentech. He oversees development efforts in Prospective Evidence Generation and real world endpoints. Leveraging his clinical development experience across Phase I-IV studies with global filing experience, he is... Read More →

Ariel Bourla

Medical Director, Flatiron Health, United States
Ariel Bourla serves as Medical Director at Flatiron Health. She oversees the development of new real-world endpoints and the incorporation of clinical images into the endpoint portfolio. She is also responsible for working with Flatiron’s partners to design prospective real-world... Read More →

Gregory Riely

Vice Chair, Clinical Research, Department of Medicine, Memorial Sloan Kettering Cancer Center, United States
Dr. Gregory Riely is a medical oncologist in the Department of Medicine at Memorial Sloan-Kettering Cancer Center. His primary research focus is in clinical research of patients with non-small cell lung cancer. He completed fellowship training in Medical Oncology at Memorial Sloan-Kettering... Read More →

Monday June 28, 2021 2:30pm - 3:30pm EDT
TBD Virtual Event Horsham, PA 19044
  01: ClinSafety-PV, Session |   03: Data-Data Standards, Session