Using healthcare systems data for outcomes in clinical trials: issues to consider at the design stage.
Alice-Maria ToaderMarion K CampbellJennifer K QuintMichael RoblingMatthew R SydesJoanna ThornAlexandra Wright-HughesLy-Mee YuTom E F AbbottSimon BondFergus J CaskeyMadeleine CloutMichelle CollinsonBethan CopseyGwyneth DaviesTimothy DriscollCarrol GambleXavier L GriffinThomas HamborgJessica HarrisDavid A HarrisonDeena HarjiEmily J HendersonPip LoganSharon B LoveLaura A MageeAlastair O'BrienMaria PufuletePadmanabhan RamnarayanAthanasios SaratzisJo SmithIvonne Solis-TrapalaClive StubbsAmanda FarrinPaula WilliamsonPublished in: Trials (2024)
We provide guidance to inform decisions about whether or not to use HSDs for outcomes, and if so, to assist trialists in working with registries and other HSD providers to improve the design and delivery of trials.