Dose finding with continuous outcome in phase I oncology trials

Area of Science:

• Oncology
• Clinical Trial Design
• Biostatistics

Background:

• Phase I clinical trials in oncology aim to determine safe and effective drug doses.
• Continuous endpoints, such as toxicity scores, are frequently used in these trials, especially for cytostatic agents.
• Current methods may lack flexibility in patient dose assignment during rapid accrual.

Purpose of the Study:

• To propose a new statistical method for dose-finding in phase I oncology trials.
• To address challenges with continuous endpoints and patient allocation in fast-accrual scenarios.
• To offer a flexible and effective approach for dose selection.

Main Methods:

• Development of a novel dose-finding algorithm for continuous endpoints.
• Simulation or comparison with existing methods to evaluate performance.
• Focus on patient allocation flexibility under high patient accrual rates.

Main Results:

• The proposed method demonstrates comparable dose selection accuracy to existing approaches.
• It offers enhanced flexibility in assigning patients to different dose levels during the trial.
• The method is particularly advantageous when patient accrual outpaces follow-up duration.

Conclusions:

• The new method provides a viable alternative for phase I oncology trials with continuous endpoints.
• It improves trial efficiency by allowing more flexible patient dose assignment.
• This approach is beneficial for trials with rapid patient enrollment and limited follow-up time.