How we developed our implementation guidance

The PeRSEVERE project aimed to reach agreement on principles to guide how the possible complexity around participation changes in research should be managed in practice, for the good of participants and the trials they take part in.

The PeRSEVERE principles are consciously ‘high—level’, and generally avoid specific, prescriptive detail about exactly what should be done.

We recognise the ‘aspirational’ nature of some of the principles, suggesting standards that may be difficult to implement perfectly in real life.

The PeRSEVERE implementation guidance, created to guide UKCRC Registered Clinical Trials Units (CTUs), goes into more detail about suggested best practice.

It expands the PeRSEVERE principles to cover all areas of clinical trial design, setup, conduct, analysis and reporting.

While some of these points may already reflect current practice, we believe this is the first attempt to assemble a single, comprehensive guide.

We have compiled the guidance from five main sources:

  • Suggestions raised by members of the PeRSEVERE collaborative group, including at a UKCRC Registered CTU Network workshop event in October 2019.
  • Suggestions and comments made by contributors to the public consultation exercise in 2021.
  • A piloting exercise in 2022, whereby 8 Registered CTUs were asked to review the final PeRSEVERE principles and explanation document and consider how they were already putting – or could put – them into practice.
  • The PeRSEVERE Principles and Explanation document itself, where this gives specific, practical suggestions or implies certain actions or approaches are needed.
  • Available evidence from published literature, obtained through non-systematic literature reviews supporting this work.

We recognise that there are areas that could benefit from further empirical work, for example formal consensus exercises to agree ‘core’ content for trial documents, such as patient information sheets.

Results of such work might supersede this guidance. However, we hope our suggestions would be a useful starting point.

We would welcome any further suggestions and feedback. We could produce updates to this implementation guidance if there was demand for this.