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Scoping review and characteristics of publicly available checklists for assessing clinical trial feasibility

Gloy, V. and Speich, B. and Griessbach, A. and Taji Heravi, A. and Schulz, A. and Fabbro, T. and Magnus, C. P. and McLennan, S. and Bertram, W. and Briel, M.. (2022) Scoping review and characteristics of publicly available checklists for assessing clinical trial feasibility. BMC Med Res Methodol, 22. p. 142.

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Abstract

BACKGROUND: Whether there is sufficient capacity and capability for the successful conduct and delivery of a clinical trial should be assessed by several stakeholders according to transparent and evidence-based criteria during trial planning. For this openly shared, user-tested, and validated tools are necessary. Therefore, we systematically examined the public availability and content of checklists which assess the study-level feasibility in the planning phase of clinical trials. METHODS: In our scoping review we systematically searched Medline, EMBASE, and Google (last search, June 2021). We included all publicly available checklists or tools that assessed study level feasibility of clinical trials, examined their content, and checked whether they were user-tested or validated in any form. Data was analysed and synthesised using conventional content analysis. RESULTS: A total of 10 publicly available checklists from five countries were identified. The checklists included 48 distinct items that were classified according to the following seven different domains of clinical trial feasibility: regulation, review and oversight; participant recruitment; space, material and equipment; financial resources; trial team resources; trial management; and pilot or feasibility studies. None of the available checklists appeared to be user-tested or validated. CONCLUSIONS: Although a number of publicly available checklists to assess the feasibility of clinical trials exist, their reliability and usefulness remain unclear. Openly shared, user-tested, and validated feasibility assessment tools for a better planning of clinical trials are lacking.
Faculties and Departments:09 Associated Institutions > Swiss Tropical and Public Health Institute (Swiss TPH)
09 Associated Institutions > Swiss Tropical and Public Health Institute (Swiss TPH) > Department of Epidemiology and Public Health (EPH) > Health Interventions > Malaria Interventions (Lengeler)
UniBasel Contributors:Taji Heravi, Ala
Item Type:Article, refereed
Article Subtype:Research Article
ISSN:1471-2288 (Electronic)1471-2288 (Linking)
Note:Publication type according to Uni Basel Research Database: Journal article
Language:English
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Last Modified:22 Dec 2022 16:27
Deposited On:22 Dec 2022 16:27

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