08/31/2020
We are inviting you to join our seminar.
Incorporating historical information and real-world evidence to improve phase I clinical trials
Dr. Ying Yuan
Professor
The University of Texas MD Anderson Cancer Center
Date: September 15th 2020
Time: 2:00 – 3:00 PM
Zoom link: https://memphis.zoom.us/j/93129315332?pwd=cVFFWmxiZ3dldU9VTjR6KzZKampCUT09
Incorporating historical data or real-world evidence has a great potential to improve the efficiency of phase I clinical trials and to accelerate drug development. For model-based designs, such as the continuous reassessment method (CRM), this can be conveniently carried out by specifying a ``skeleton," i.e., the prior estimate of dose limiting toxicity (DLT) probability at each dose. In contrast, little work has been done to incorporate historical data or real-world evidence into model-assisted designs, such as the Bayesian optimal interval (BOIN) and keyboard designs. This has led to the misconception that model-assisted designs cannot incorporate prior information. In this paper, we propose a unified framework that allows for incorporating historical data or real-world evidence into model-assisted designs. The proposed approach uses the well-established ``skeleton" approach, combined with the concept of prior effective sample size, thus it is easy to understand and use. More importantly, our approach maintains the hallmark of model-assisted designs: simplicity---the dose escalation/de-escalation rule can be tabulated prior to the trial conduct. Extensive simulation studies show that the proposed method can effectively incorporate prior information to improve the operating characteristics of model-assisted designs, similarly, to model-based designs.
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