News & Media

New PeRSEVERE Paper Published

New Paper Describes the Development of the PeRSEVERE Principles & Guidance

The PeRSEVERE project was started within the UKCRC Registered CTU Network in 2019 to address the lack of detailed guidance for managing ‘withdrawal’ of consent and other participation changes in our trials.

Participation changes can be complex, and it can be unhelpful to view them as binary – i.e. to view the only possible participation statuses as ‘taking part’ or ‘withdrawn’.

Motivated by what they thought shouldn’t be happening in their trials, a multi-disciplinary group came together to try to agree how participation changes should be managed.

A new paper published by the project group, entitled Standardising management of consent withdrawal and other clinical trial participation changes: The UKCRC Registered Clinical Trials Unit Network’s PeRSEVERE project describes how they developed the PeRSEVERE principles through discussion and debate within a large, multidisciplinary collaboration, including research professionals and public contributors.

The team took an inclusive approach to drafting the principles, incorporating new ideas if they felt they were within the project scope. The draft principles were then scrutinised through an international consultation survey which focussed on the principles’ clarity, feasibility, novelty and acceptability.

After finalising PeRSEVERE guiding principles, we developed accompanying implementation guidance using several sources such as the SPIRIT/CONSORT statements.

The principles and all accompanying guidance and resources are available at https://persevereprinciples.org/.

Previous publications arising from the PeRSEVERE project can be found here:

– A paper about their guidance and how it was developed with a group of public contributors

– A paper reporting the results of a survey of REC members for their views on the communications guidance