Oncology dose finding studies, in general, aim at determining the maximum tolerated
dose (MTD) reflecting the desire to treat patients who have limited options under the
assumption that higher drug doses will have better therapeutic activity. We are
describing different methods (ie 3+3, mTPI, mTPI-2, and BLRM). This seminar will
feature speakers from Pfizer Inc., to share their insights and the recent statistical
innovations to address the challenges.
In addition to safety evaluation, Early Sign of Efficacy (ESOE) is a critical step in all
early clinical programs to extend the development of a molecule or not. Robust and
consistent calculation of the probability of making the right decision is critical.
Innovative methodologies are needed to optimize these calculations and ensure all
molecules are assessed in the same way across the oncology portfolio.
Case studies will be discussed for dose finding and the utilization of Bayesian statistics
in ESOE evaluation.
13 Maggio 2022
Roberto Bugarini
Head of Oncology Biostatistics (ECD), Pfizer, San Diego, CA, USA
Ray Li
Director of Biostatistics (ECD), Pfizer, Cambridge, MA, USA