Adaptive Trial Designs in Rheumatology: Report from the OMERACT Special Interest Group. Academic Article uri icon

Overview

abstract

  • OBJECTIVE: Adaptive trial design was developed initially for oncology to improve trial efficiency. If optimized for rheumatology, it may improve trial efficiency by reducing sample size and time. METHODS: A systematic review assessed design of phase II clinical trials in rheumatoid arthritis. RESULTS: Fifty-six trials were reviewed. Most trials had 4 groups (1 control and 3 intervention), with an average group size of 34 patients. American College of Rheumatology 20 measured at 16 weeks was the most commonly used primary endpoint. CONCLUSION: The next step is to undertake a systematic review of adaptive designs used in early-phase trials in nonrheumatic conditions.

publication date

  • February 15, 2019

Research

keywords

  • Antirheumatic Agents
  • Arthritis, Rheumatoid
  • Clinical Trials as Topic
  • Research Design
  • Rheumatology

Identity

Scopus Document Identifier

  • 85072775404

Digital Object Identifier (DOI)

  • 10.3899/jrheum.181054

PubMed ID

  • 30770514

Additional Document Info

volume

  • 46

issue

  • 10