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Hi3 + 3: A model-assisted dose-finding design borrowing historical data.

Yunshan Duan1, Sue-Jane Wang2, Yuan Ji3

  • 1Department of Mathematics, Fudan University, China.

Contemporary Clinical Trials
|May 21, 2021
PubMed
Summary
This summary is machine-generated.

The new Hi3+3 design enhances early-phase clinical trials by using historical data to improve efficiency and patient safety. This statistical approach simplifies dose-finding, making drug development faster and more cost-effective.

Keywords:
Bayesian modelPhase I trialsPower priorReal world dataToxicity

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Area of Science:

  • Clinical Trials
  • Biostatistics
  • Drug Development

Background:

  • Historical data in Phase I clinical trials can originate from multi-regional programs, drug reformulations, or prior studies of similar drugs.
  • Leveraging historical data in statistical designs can significantly reduce costs, accelerate drug development timelines, and enhance patient safety.

Purpose of the Study:

  • To improve the efficiency of dose-finding trials by incorporating historical data.
  • To maintain patient safety throughout the trial process.
  • To develop a hybrid statistical design that balances probability models and algorithmic decision-making for practical application.

Main Methods:

  • Introduction of the Hi3+3 design, where 'H' signifies the use of historical data.
  • Application of the power prior method to borrow information from historical data, defining an effective sample size (ESS).
  • Adaptation of the i3+3 design's decision rules, integrating historical data through the power prior and ESS, with pre-tabulated dosing decisions for practical use.

Main Results:

  • The Hi3+3 design demonstrates superiority over the i3+3 design in most investigated scenarios due to the effective borrowing of historical data.
  • The design maintains a high level of patient safety and comparable performance, even with incompatible historical data.
  • Simulation results illustrate the design's capability to identify the maximum tolerated dose (MTD) without significant compromise.

Conclusions:

  • The Hi3+3 design offers a desirable approach for dose-finding trials that incorporate historical data.
  • Its demonstrated safety, efficiency, and simplicity make it a practical choice for advancing drug development.
  • This method effectively utilizes prior information to optimize early-phase clinical trial outcomes.