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 CalvertPublished 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.