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Invited Paper Session

Innovations in Clinical Trial Designs for Medical Tests

Mon, Aug 5, 8:30 AM - 10:20 AM

Gene PennelloOrganizerBipasa BiswasChair

Section on Medical Devices and Diagnostics

5 Presentations

An Adaptive Seamless Design for Linking a Diagnostic Accuracy Study and a Randomized Test-treatment Study

8:35 AM - 8:55 AM

Antonia Zapf (University Hospital Hamburg-Eppendorf)

Clinical Trial Designs for Medical Tests and Their Estimands

8:55 AM - 9:15 AM

Gene Pennello (Food and Drug Administration)

Co-authors: Jingjing Ye (BeiGene)

Efficient Risk-based Collection of Biospecimens in Cohort Studies: Designing a Prospective Study of Diagnostic Performance for Multicancer Detection Tests

9:15 AM - 9:35 AM

Increasing Power in Screening Trials by Testing Stored Specimens in the Control Arm: Application to Multicancer Detection Screening

9:35 AM - 9:55 AM

Hormuzd Katki (National Cancer Institute)

Reduced Randomized Designs for Clinical Trials of Medical Tests

9:55 AM - 10:15 AM

Patrick Bossuyt (Amsterdam University Medical Centers)

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