Using healthcare systems data for outcomes in clinical trials: issues to consider at the design stage.

ABSTRACT:

Background

Healthcare system data (HSD) are increasingly used in clinical trials, augmenting or replacing traditional methods of collecting outcome data. This study, PRIMORANT, set out to identify, in the UK context, issues to be considered before the decision to use HSD for outcome data in a clinical trial is finalised, a methodological question prioritised by the clinical trials community.

Methods

The PRIMORANT study had three phases. First, an initial workshop was held to scope the issues faced by trialists when considering whether to use HSDs for trial outcomes. Second, a consultation exercise was undertaken with clinical trials unit (CTU) staff, trialists, methodologists, clinicians, funding panels and data providers. Third, a final discussion workshop was held, at whic

SUBMITTER: Toader AM 

PROVIDER: S-EPMC10823676 | biostudies-literature | 2024 Jan

REPOSITORIES: biostudies-literature