Event
Index Date Selection for External Comparators
Friday, July 25, 2025
9:00 AM - 11:30 AM EDT
Triangle CERSI
triangle_cersi@unc.edu
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 entitled “Index Date Selection for External Comparators” on Friday, July 25, 2025.
Overview:
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 us 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.
Meeting Materials:
Presentation Slides:
- Statistical and Regulatory Considerations for Externally Controlled Trials (Arup Sinha, Food and Drug Administration)
- Performance of Index Date Selection Methods for a Standard-of-Care External Comparator of a Single Arm Trial (Laura Hester, Johnson & Johnson)
- Impact of Index Line Selection: An Example from R/R Follicular Lymphoma (Matthew Maurer, Mayo Clinic)
- Sequential Nested Trial Emulation: Clarifying the Index Date, Muddying the Target Population (Alex Breskin, Regeneron)
- Index Date Selection for External Comparators - Relevant Frameworks and 5 Special Cases (Gerd Rippin, IQVIA)
Please email triangle_cersi@unc.edu if you would like a copy of the meeting transcript.
Funding Acknowledgement:
This Program is supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award Center of Excellence in Regulatory Science and Innovation, U01FD007857 totaling $867,730 from Oncology Center of Excellence. The contents are those of the author(s) and do not necessarily represent the official views, nor an endorsement by, FDA/HHS, or other U.S. Government.
