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A Study Design for Augmenting the Control Group in a Randomized Controlled Trial: A Quality Process for Interaction

Yunling Xu1, Nelson Lu2, Lilly Yue2

  • 1Division of Biostatistics, OSB/CDRH, Food and Drug Administration, 10903 New Hampshire Avenue, WO66, Silver Spring, MD, 20993, USA. Yun-ling.xu@fda.hhs.gov.

Therapeutic Innovation & Regulatory Science
|February 20, 2020
PubMed
Summary

Augmenting randomized controlled trial control groups with external data can save time and cost. A new quality process ensures study validity and integrity when using historical or registry data.

Keywords:
2-stage design2-step assessmentexternal dataindependent statisticianquality processrandomized controlled trial

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