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Background -- In phase I clinical trials, historical data may be availablethrough multi-regional programs, reformulation of the same drug, or previoustrials for a drug under the same class. Statistical designs that borrowinformation from historical data can reduce cost, speed up drug development,and maintain safety. Purpose -- Based on a hybrid design that partly usesprobability models and partly uses algorithmic rules for decision making, weaim to improve the efficiency of the dose-finding trials in the presence ofhistorical data, maintain safety for patients, and achieve a level ofsimplicity for practical applications. Methods -- We propose the Hi3+3 design,in which the letter "H" represents "historical data". We apply the idea inpower prior to borrow historical data and define the effective sample size(ESS) of the prior. Dose-finding decision rules follow the idea in the i3+3design while incorporating the historical data via the power prior and ESS. Theproposed Hi3+3 design pretabulates the dosing decisions before the trialstarts, a desirable feature for ease of application in practice. Results -- TheHi3+3 design is superior than the i3+3 design due to information borrow fromhistorical data. It is capable of maintaining a high level of safety for trialpatients without sacrificing the ability to identify the correct MTD.Illustration of this feature are found in the simulation results. Conclusion --With the demonstrated safety, efficiency, and simplicity, the Hi3+3 designcould be a desirable choice for dose-finding trials borrowing historical data.

Hi3+3: A Model-Assisted Dose-Finding Design Borrowing Historical Data