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

Comput Methods Programs Biomed. 2007 Oct;88(1):8-17. doi: 10.1016/j.cmpb.2007.06.006. Epub 2007 Aug 24.

Abstract

The continual reassessment method is a recommended dose escalation design for including patients in phase I clinical trials designed to estimate the maximum tolerated dose. However, for a particular trial, the implementation of these methods requires extensive computer programming. Standard 3+3 designs do not require this, but have shown to possess poor statistical properties. np1 is a user friendly computer program which has implemented two continual reassessment methods for simulating and conducting a phase I clinical trial. Several options allow the user to investigate operating characteristics under various scenarios.

MeSH terms

  • Bayes Theorem
  • Clinical Trials, Phase I as Topic / methods*
  • Computer Simulation
  • Dose-Response Relationship, Drug
  • Humans
  • Maximum Tolerated Dose*
  • Software*