New Joint Webinar Programme Announced
09-01-2021
2024 has been a busy and important year for the PeRSEVERE (PRincipleS for handling end-of-participation EVEnts in clinical trials REsearch) Project.
Read on to find out more.
The PeRSEVERE project was started within the 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it can be unhelpful to view them as binary – i.e. to view the only possible participation statuses as ‘taking part’ or ‘withdrawn’.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. This eventually led to development of the PeRSEVERE guiding principles. The principles and all accompanying guidance and resources are available at https://persevereprinciples.org/.
PeRSEVERE had several outputs at the ICTMC.
– They held another educational workshop to explore the PeRSEVERE principles and how they can be implemented in real-life scenarios.
– They presented a poster on how we have disseminated the broad range of guidance included in PeRSEVERE.
– A trial team at the Leeds CTRU presented a poster on implementing PeRSEVERE within their trial, with a specific focus on providing participants with the information they might want or need at the time they stop taking part.
The two posters can be viewed on the Leeds CTRU ICTMC page: https://lictrxictmc.my.canva.site/.
There are now 10 pages of resources available via the PeRSEVERE website: https://persevereprinciples.org/resources/.
These help CTUs implement the PeRSEVERE principles, and can be used either as they are in their downloadable form, or to inform development of local CTU templates or trial-specific documents.
The latest resources added are:
– Template study protocol content with suggestions for how the content about managing participation changes could be organised, and suggested wording.
– Two additional scenarios showing how the PeRSEVERE principles can help manage (or avoid) the sorts of complex participation change scenarios that can arise in trials. These scenarios were included in the ICTMC educational workshop mentioned above.
Two publications have so far come from the PeRSEVERE-related work on end-of-participation communications:
– 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
They are also working on a publication about the PeRSEVERE principles themselves and the public consultation they ran to inform their development.
In another spin-off project from PeRSEVERE, members of the PeRSEVERE team and the Trial Methodology Research Partnership’s retention working group conducted a scoping review to see what data trial teams collect about participation changes. The initial results of this work were also presented at ICTMC. They will be used to generate some guidance for good practice in collecting data about participation changes, which will be shared with all CTUs in due course.
If you have any questions about the site, please feel free to contact us. We are always looking for ways to better serve our members - YOU are important to us!
If you have any questions about the site, please feel free to contact us. We are always looking for ways to better serve our members - YOU are important to us!
