Index Date Selection for External Comparators

The U.S. Food and Drug Administration (FDA) Oncology Center of Excellence in collaboration with the Triangle Center of Excellence in Regulatory Science and Innovation (CERSI) and UNC Pharmacoepidemiology will host a virtual public collaborative symposium.

When randomization isn't feasible or ethical, researchers increasingly turn to real-world data to construct external comparator groups. A critical design challenge in these studies is selecting an appropriate index date - the point at which outcome tracking begins for the comparator group. Join the Triangle CERSI for expert presentations and in-depth discussions on the methodological and practical considerations of index date selection, illustrated with real-world applications. This interactive symposium brings together experts from the FDA, pharmaceutical industry, academia, and beyond to share insights and collectively advance best practices in this area of oncology and other types of research.

This workshop is offered virtually. Registration is free of charge but is required. Registrants will receive confirmation when they register. For more information about this event, please visit trianglecersi.org.

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Initial Outcomes of the NOHARM Pragmatic Trial

This NIH Collaboratory Rethinking Clinical Trials Grand Rounds features:

Jon Tilburt, MD
Professor of Medicine
Mayo Clinic in Arizona

Andrea Cheville, MD
Professor of Physical Medicine and Rehabilitation
Mayo Clinic in Minnesota

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