np1: a computer program for dose escalation strategies in phase I clinical trials

Area of Science:

• Clinical Trials Methodology
• Biostatistics
• Pharmacometrics

Background:

• Phase I clinical trials are crucial for estimating the maximum tolerated dose (MTD).
• The Continual Reassessment Method (CRM) is statistically preferred for dose escalation but is complex to implement.
• Traditional 3+3 designs are simpler but have suboptimal statistical performance.

Purpose of the Study:

• To introduce np1, a user-friendly software program for implementing CRM in phase I trials.
• To facilitate the simulation and execution of CRM-based dose escalation studies.
• To enable investigation of CRM operating characteristics under diverse trial scenarios.

Main Methods:

• Development of the np1 computer program.
• Implementation of two distinct CRM algorithms within np1.
• Inclusion of user-configurable options for scenario simulation.

Main Results:

• np1 provides a simplified interface for complex CRM dose escalation designs.
• The software allows for the simulation and analysis of phase I clinical trial operating characteristics.
• Facilitates comparison between CRM and other dose-finding designs.

Conclusions:

• np1 enhances the accessibility and practical application of advanced dose escalation methods.
• The software supports robust trial design and analysis for MTD estimation.
• User-friendly implementation of CRM improves the statistical rigor of phase I trials.