The rapid enrollment design for Phase I clinical trials

Stat Med. 2016 Jul 10;35(15):2516-24. doi: 10.1002/sim.6886. Epub 2016 Feb 1.

Abstract

We propose a dose-finding design for Phase I oncology trials where each new patient is assigned to the dose most likely to be the target dose given observed data. The main model assumption is that the dose-toxicity curve is non-decreasing. This method is beneficial when it is desirable to assign a patient to a dose as soon as the patient is enrolled into a study. To prevent assignments to doses with limited toxicity information in fast accruing trials we propose a conservative rule that assigns temporary fractional toxicities to patients still in follow-up. We also recommend always using a safety rule in any fast accruing dose-finding trial. Copyright © 2016 John Wiley & Sons, Ltd.

Keywords: CRM; Phase I trial; RED; TITE-CRM; mTPI.

MeSH terms

  • Clinical Trials, Phase I as Topic*
  • Dose-Response Relationship, Drug
  • Humans
  • Maximum Tolerated Dose
  • Medical Oncology
  • Patient Selection
  • Research Design*