Modified Toxicity Probability Interval Design Version 2
In 2007, Laiya founder developed the original dose-finding TPI design based on toxicity interval, which trail-blazed a new path for phase I clinical trial designs. Over the next 10 years of diligent research, we have developed mTPI (JCO; Ji et al., 2010) and mTPI-2 (Contemp. Clinical Trials.; Guo et al., 2017), and published related papers in top scientific journals. Since mTPI’s debut, it has been adopted by a number of pharmaceutical companies and has passed FDA clinical trial protocol review.
The mTPI-2 design uses interval-based Bayesian designs for dose finding, the decision rules of which correspond to an optimal rule under a formal Bayesian decision theoretic framework. It improves mTPI in terms of safety and has demonstrated superior performance in extensive simulations.
- Identifies the MTD with higher power, which improves the overall success rate of a clinical trial.
- Flexibility: Applicable to clinical trials of different target toxicity probabilities, which satisfies the need of different oncology drug development.
- Better Safety: Preventing patients from being exposed to excessive dose levels.
- Simplicity: Decisions table can be generated prior to the clinical trial, making the design more transparent and easier to implement.