Table 1 The four case studies selected
Case study name | Area | Date of publication | Brief description of project objectives | Actionable output(s) – (type of output) |
|---|---|---|---|---|
Developing progression criteria for internal pilot studies [24] | Design | 2017 | “This paper outlines the key issues to consider in the optimal development and review of operational progression criteria for RCTs with an internal pilot phase.” | Ten top tips for developing and using progression criteria for internal pilot studies.—(Guidelines/recommendations) |
DAMOCLES [23] | Conduct | 2005 | “One main aim of the DAMOCLES study was, therefore, to develop a template for a charter to systematically describe the operating practices and procedures of a DMC.” | “The charter proposed in this paper aims to promote a systematic and transparent approach to the structure and operation of DMCs. […] A worked example of the charter is available on the internet.” – (Template document) |
Statistical analysis plans (SAPS) [22] | Analysis | 2017 | “[…] to develop recommendations for a minimum set of items that should be addressed in SAPs for clinical trials, developed with input from statisticians, previous guideline authors, journal editors, regulators, and funders.” | “Recommendations are provided for a minimum set of items that should be addressed and included in SAPs for clinical trials. Examples are provided to illustrate each item, along with an explanation of the rationale and detailed description of the issues to be addressed.” – (Guidelines/recommendations) |
RECAP [21] | Reporting | 2020 | “[…] aims to generate participant-centred, evidence-based recommendations for trialists to implement the dissemination of results to trial participants | “Trial teams should develop appropriately resourced plans and consult patient partners and trial participants on how ‘best’ to share key messages with regard to content, mode, and timing. The study findings provide trial teams with clear guidance on the core considerations of the ‘what, how, when and who’ with regard to sharing results summaries.” – (Guidelines/recommendations) |