Article
Currently available checklists and tools for the assessment of clinical trial feasibility – a scoping review
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Authors
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Viktoria Luise Gloy
- University Hospital Basel, University Basel, Department of Clinical Research, Basel, Schweiz
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Benjamin Speich
- University Hospital Basel, University Basel, Department of Clinical Research, Basel, Schweiz; University of Oxford, Oxford, Großbritannien
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Alexandra Griessbach
- University Hospital Zurich, Clinical Trials Center, Zurich, Schweiz
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Thomas Fabbro
- University Hospital Basel, University Basel, Department of Clinical Research, Basel, Schweiz
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Ala Taji Heravi
- Swiss Tropical and Public Health Institute, Schweiz
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Christiane Pauli Magnus
- University Hospital Basel, University Basel, Department of Clinical Research, Basel, Schweiz
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Matthias Briel
- University Hospital Basel, University Basel, Department of Clinical Research, Basel, Schweiz
| Published: | February 12, 2020 |
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Outline
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Background/research question: One out of four clinical trials are not completed as planned, mostly because of poor recruitment. This constitutes a considerable waste of research resources. Tools or checklists that can be used by researchers, funding agencies or research ethics committees to assess the feasibility of clinical trials may help to improve their planning, conduct, and successful completion. To our knowledge, a systematic overview of available tools or checklists to assess trial feasibility is lacking. Therefore, we aimed to conduct a scoping review of the currently available tools or checklists in order to identify domains that may determine clinical trial feasibility.
Methods: We systematically searched Medline and EMBASE via Ovid from inception to 19.09.2019 for relevant articles. Currently we are screening titles and abstracts of the identified references. By the time of the congress, we will have completed the full-text screening. In addition, we will have searched the internet via Google.com with pre-specified word combinations and the homepages of relevant research stakeholder organisations for any other relevant publication (e.g. electronic files). Of the included tools or checklists we will qualitatively summarize information on: publication source; country; explanations how to use the tool; description of any user testing or validation; the areas covered (protocol/clinical relevance, recruitment, sponsor, resources/logistics); the basis for the assessment (e.g. protocol, synopsis); the intended users of the tool/checklists; whether the assessment is applicable specifically for investigator- or industry-initiated trials; and the level of the feasibility testing (e.g. site level, study level).
Results: By the time of the congress, we will present the results of our scoping review including the characteristics of the identified tools or checklists.
Conclusion: This systematically gathered information will provide a useful overview for relevant stakeholders and provide the evidence-base for further evaluations including user testing and validation efforts in order to optimize clinical trial feasibility.
Competing interests: The authors declare no conflicts of interest.
