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Web-Based Lectures

Previously recorded webinars are available through the LearnSTAT OnDemand program.

Current Webinar Offerings:

December 8, 2015 Clinical Trial Designs for Validating Prognostic and Predictive Markers in Oncology

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Title: Clinical Trial Designs for Validating Prognostic and Predictive Markers in Oncology
Presenter: Daniel J. Sargent, Mayo Clinic
Date and Time: Tuesday, December 8, 2015, 12:00 p.m. - 2:00 p.m. Eastern time
Sponsor: Biopharmaceutical Section and Section on Medical Devices and Diagnostics

Registration Deadline: Friday, December 4, at 12:00 p.m. Eastern time

Increasing scientific knowledge is creating both substantial opportunities and challenges in oncology drug development. As diseases are often sub-stratified into biomarker-based groups, usual paradigms for phase II and III trials may no longer apply. In some circumstances, a carefully conducted retrospective-prospective analysis may provide sufficient evidence of a predictive biomarker for clinical use. Prospectively planned, enrichment designs are appropriate when preliminary evidence suggests that patients with/without that marker profile do not benefit from treatments in question; however this may leave questions unanswered regarding the activity of an agent in a larger but still relevant population. An unselected design is optimal where preliminary evidence regarding treatment benefit and assay reproducibility is uncertain. The biomarker-based strategy design may be useful when there is a choice between many treatment options. Adaptive analysis designs allow for pre-specified data-driven marker-defined subgroup analyses from a RCT. Umbrella or basket trials enroll large groups of patients with subsequent assignment to either individual randomized trials or single arm investigations. These trials may be disease specific, or may include patients from multiple sites who share a common biomarker status. We discuss features of these various novel design strategies in the context of multiple ongoing and planned real trials. Emphasis will be placed on practical considerations that may impact an academically optimal design.

Registration Fees:
Biopharmaceutical Section Members: $44
Section on Medical Devices and Diagnostics Member: $44
ASA Members: $59
Nonmembers: $74

Each registration is allowed one web connection and one audio connection. Multiple persons are encouraged to view each registered connection (for example, by projecting the webinar in a conference room).


Access Information
Registered persons will be sent an email the afternoon of Friday, December 4, with the access information to join the webinar and the link to download and print a copy of the presentation slides.