What is it?
The Y Study is a follow-on project to PeRSEVERE. It is aiming to standardise how reasons for participation changes are collected in clinical trials, and provide resources to help clinical trial teams.
We will start the Y Study by gathering lots of examples of reasons for participation changes. These might be reasons related to participants withdrawing their consent to take part, clinicians’ reasons for recommending that participants stop taking part in some aspects of a trial, or other reasons.
We will then form the examples of reasons into a standardised framework. This will mean different trials can collect and use reasons for participation changes in consistent ways, ensuring they make the most of this potentially useful information.
We will then work with people from various relevant groups, including research professionals and members of the public, to agree the framework.
Once we have agreed the framework, we will develop standards and guidance for collecting and using reasons for participation changes in practice. This will cover data collection, statistical analysis and trial reporting.
We have found evidence that reasons for participation changes are not clearly collected at the moment. Improving this could help researchers improve their trials, and over time could make better trials that are easier for participation to take part in.
If you would like to hear more about this new project and get invitations to help out, feel free to join our mailing list. Note that this mailing list also gives the option of hearing the results of ‘the Y Survey’, which is a preliminary survey whose results will feed into the Y Study. You will have options to hear about the survey results, or the future work on the Y Study, or both. You can consider joining the mailing list using this Microsoft Forms page.