Dear all,
We present our software for calculating operating characteristics of phase I clinical trials. Our software is user-friendly and straightforward to use. Simply access the dropbox link down below and unzip the compressed folder. Inside the folder, you will find a script file named run.vbs. Double click to open our software.
To use our software, first input parameters such as dose de-escalation (with vs. without), dose levels, true probability of DLT at each dose level as well as corresponding dosages (optional). Table and graphic outputs will be produced and made downloadable for further editing purposes.
Thank you,
Dr. Zhengjia Chen & Youyun Zheng
Abstract:
Among various Phase I clinical trial designs, rule-based standard 3+3 design is still the most widely utilized one for its simplicity and robustness. It is necessary to have crucial operating characteristics of the Phase I clinical trial before it starts. Based on assumed probability of Dose Limiting Toxicity (DLT) of each tested dose level, Lin and Shih had elaborated the formulas to calculate the 5 key operating characteristics of Phase I clinical trial using the two subtypes of Standard 3+3 designs (with vs without dose de-escalation): Probability of each dose level being chosen as Maximum Tolerated Dose (MTD); Expected number of patients treated at each dose level; Expected number of patients experiencing DLT at each dose level; Target Toxicity Level (TTL) (expected probability of DLT at MTD); Expected total number of patients experiencing DLT. But understanding the formulas requires advanced statistical knowledge and the formulas are also too complicated to be used directly. To facilitate the application, we develop stand-alone interactive software for the convenient calculations. The calculated results are presented in tables and plots that can be saved and easily edited for further usages.