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

Toader, Alice-Maria ORCID: 0000-0002-3801-3486, Campbell, Marion K, Quint, Jennifer K, Robling, Michael, Sydes, Matthew R, Thorn, Joanna, Wright-Hughes, Alexandra, Yu, Ly-Mee, Abbott, Tom EF, Bond, Simon
et al (show 25 more authors) (2024) Using healthcare systems data for outcomes in clinical trials: issues to consider at the design stage. Trials, 25 (1). p. 94.

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<h4>Background</h4>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.<h4>Methods</h4>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 which the results of the consultation were fed back, case studies presented, and issues considered in small breakout groups.<h4>Results</h4>Key topics included in the consultation process were the validity of outcome data, timeliness of data capture, internal pilots, data-sharing, practical issues, and decision-making. A majority of consultation respondents (n = 78, 95%) considered the development of guidance for trialists to be feasible. Guidance was developed following the discussion workshop, for the five broad areas of terminology, feasibility, internal pilots, onward data sharing, and data archiving.<h4>Conclusions</h4>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.

Item Type: Article
Uncontrolled Keywords: Humans, Registries, Information Dissemination, Delivery of Health Care
Divisions: Faculty of Health and Life Sciences
Faculty of Health and Life Sciences > Institute of Population Health
Depositing User: Symplectic Admin
Date Deposited: 02 Feb 2024 10:36
Last Modified: 02 Feb 2024 10:38
DOI: 10.1186/s13063-024-07926-z
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