# Incorporating historical information to improve phase I clinical trial designs

arXiv: https://arxiv.org/abs/2004.12972 · HTML: https://mlsanity.com/paper/2004.12972/

## Key facts

- Cited by 1 papers in the map (data through 14 Oct 2026).
- First posted on arXiv 27 Apr 2020.

## Built on by (most cited first, 1 of 1)

- [Shared Keyboard: An improved Bayesian design for phase I clinical trials via Beta kernel process](https://mlsanity.com/paper/2605.25043/) (2026)

## Abstract (arXiv)

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), keyboard, and modified toxicity probability interval (mTPI) 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.