Monitoring strategies for clinical intervention studies

Klatte, Katharina and Pauli-Magnus, Christiane and Love, Sharon B. and Sydes, Matthew R. and Benkert, Pascal and Bruni, Nicole and Ewald, Hannah and Arnaiz Jimenez, Patricia and Bonde, Marie Mi and Briel, Matthias. (2021) Monitoring strategies for clinical intervention studies. Cochrane Database of Systematic Reviews, 2021 (12). MR000051.

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Official URL: https://edoc.unibas.ch/85508/

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AUTHORS' CONCLUSIONS: The evidence base is limited in terms of quantity and quality. Ideally, for each of the five identified comparisons, more prospective, comparative monitoring studies nested in clinical trials and measuring effects on all outcomes specified in this review are necessary to draw more reliable conclusions. However, the results suggesting risk-based, targeted, and mainly central monitoring as an efficient strategy are promising. The development of reliable triggers for on-site visits is ongoing; different triggers might be used in different settings. More evidence on risk indicators that identify sites with problems or the prognostic value of triggers is needed to further optimize central monitoring strategies. In particular, approaches with an initial assessment of trial-specific risks that need to be closely monitored centrally during trial conduct with triggered on-site visits should be evaluated in future research.
Faculties and Departments:10 Zentrale universitäre Einrichtungen > Universitätsbibliothek
UniBasel Contributors:Ewald, Hannah and Klatte, Katharina and Pauli-Magnus, Christiane and Benkert, Pascal and Bruni, Nicole and Briel, Matthias
Item Type:Article, refereed
Article Subtype:Research Article
Note:Publication type according to Uni Basel Research Database: Journal article
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Last Modified:15 Nov 2022 16:20
Deposited On:15 Nov 2022 16:20

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