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Determining the Suitability of Registries for Embedding Clinical Trials in the United States: A Project of the Clinical Trials Transformation Initiative.

J Stephen MikitaJules MitchelNicolle M GattoJohn LaschingerJames E TchengEmily P ZeitlerArlene S SwernE Dawn FlickChristopher DowdTheodore LystigSara B Calvert
Published in: Therapeutic innovation & regulatory science (2020)
The project identifies a clear role for registries in creating a sustainable and reusable infrastructure to conduct clinical trials. Adoption of these recommendations will facilitate the ability to perform high-quality and efficient prospective registry-based clinical trials.
Keyphrases
  • clinical trial
  • quality improvement
  • phase ii
  • open label
  • phase iii
  • study protocol
  • gene expression
  • dna methylation
  • placebo controlled