  This article summarizes the discussions from the American Statistical
Association (ASA) Biopharmaceutical (BIOP) Section Open Forum that took place
on December 10, 2020 and was organized by the ASA BIOP Statistical Methods in
Oncology Scientific Working Group, in coordination with the US FDA Oncology
Center of Excellence. Diverse stakeholders including experts from international
regulatory agencies, academicians, and representatives of the pharmaceutical
industry engaged in a discussion on the use of non-concurrent control in Master
Protocols for oncology trials. While the use of non-concurrent control with the
concurrent control may increase the power of detecting the therapeutic
difference between a treatment and the control, the panelists had diverse
opinion on the statistical approaches for modeling non-concurrent and
concurrent controls. Some were more concerned about the temporality of the
non-concurrent control and bias introduced by different confounders related to
time, e.g., changes in standard of care, changes in patient population, changes
in recruiting strategies, changes in assessment of endpoints. Nevertheless, in
some situations such as when the recruitment is extremely challenging for a
rare disease, the panelists concluded that the use of a non-concurrent control
can be justified.
