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

Authors
  • Kramar, Andrew1
  • Houédé, Nadine
  • Paoletti, Xavier
  • 1 CRLC Val d'Aurelle-Paul Lamarque, Unité de Biostatistiques, Parc Euromedecine, 34298 Montpellier Cedex 5, France. [email protected]
Type
Published Article
Journal
Computer Methods and Programs in Biomedicine
Publisher
Elsevier
Publication Date
October 2007
Volume
88
Issue
1
Pages
8–17
Identifiers
PMID: 17719124
Source
Medline
License
Unknown

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.

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