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. 2022 May 19;22(1):142.
doi: 10.1186/s12874-022-01617-6.

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

Viktoria Gloy  1 , Benjamin Speich  2   3 , Alexandra Griessbach  2   4 , Ala Taji Heravi  2   5 , Alexandra Schulz  6 , Thomas Fabbro  6 , Christiane Pauli Magnus  6 , Stuart McLennan  7 , Wendy Bertram  8 , Matthias Briel  2   9
Affiliations

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

Viktoria Gloy et al. BMC Med Res Methodol. .

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.

Keywords: Checklist; Feasibility assessment; Randomized controlled trials; Validation.

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Conflict of interest statement

All authors have declared that no competing interests exist.

Figures

Fig. 1
Fig. 1
Results of the information search
See this image and copyright information in PMC

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