Rolling Toxicity Probability Interval Design
The Rolling Toxicity Probability Interval Design (R-TPI) provides a fast and efficient solution for accelerating phase I dose finding trials. The R-TPI design is capable of 1) shortening the duration of phase I dose-ﬁnding clinical trials, 2) maintaining safety and reliability at the same time despite of trial acceleration. By shortening the trial duration, R-TPI can 1) reduce the operational cost of the clinical trial and 2) speed up the whole drug development timeline. In the meanwhile, R-TPI is transparent in operation and easy to implement, as its decision table can be pre-tabulated at forefront.
- Compared to the conventional cohort-based approach (such as 3+3, CRM or mTPI-2), R-TPI is able to save about 10%-25% time in completing a trial without sacrifice of safety or reliability.
- Compared to the Rolling Six design, R-TPI is safer and more reliable in terms of finding MTD, while avoiding exposing many patients to low doses.