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Session 4: Recommendations on Potentially Suitable AuditTrials
Session Chair(s)
Andrea Perrone, MD
Head of Clinical Imaging, Translational Medicine, Merck, United States
The session will focus on clinical aspects related to optimal trial types for an audit including criteria considerations, metastatic v. adjuvant trial setting, and endpoints. Operational aspects such as the workflow to incorporate clinical data and technology to minimize reader bias as well as suggestions to mitigate reader variability in an audit setting will be presented.
Speaker(s)
Andrea Perrone, MD
Head of Clinical Imaging, Translational Medicine, Merck, United States
Operational Aspects for Considerations
Lawrence H. Schwartz, MD
Chairman, Department of Radiology, Columbia University College of Physicians and Surgeons, United States
Clinical Aspects of Audits based on Disease Indication and Trial Design
Gregory V Goldmacher, MD, PhD, MBA
Senior Director, Translational Biomarkers, Merck & Co. Inc., United States
Reader Variability in the “Ideal Setting" v. Audit
Panel Q&A
, United States
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