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UKTMN Members' Webinar - The PeRSEVERE Project
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UKTMN Members' Webinar - The PeRSEVERE Project

The PeRSEVERE project: safeguarding research and enhancing participant rights when people want to stop taking part in a trial

 Export to Your Calendar 17/06/2020
When: Wednesday, June 17, 2020
12:00 PM
Where: Webinar
United Kingdom
Presenter: Will Cragg (University of Leeds)
Contact: UKTMN


Online registration is available until: 15/06/2020
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Trial participants' right to withdraw their consent to participate is fundamental to ethical clinical trial conduct. Participants stopping some or all elements of participation usually leads to missing data in trial analysis, which reduces trials' ability to reliably answer research questions. Significant work has been done on handling missing data in trial analyses, but these methods are based on sometimes unverifiable assumptions, and it is recognised that it is better to avoid missing data altogether. There is also emerging evidence about how to reduce the proportion of people in each trial who express a wish to reduce or stop their participation. However, in current practice it is still common for as many as 10% or more of people recruited to a trial to decide they no longer want to participate (before their planned end of participation).

 

It might be that trials are not always optimally set up to handle this inevitability. The PeRSEVERE project (PRincipleS for handling end of follow-up EVEnts in clinical trials REsearch), supported by the UK CRC Registered CTU Network and led by Network members, is seeking to address this. We are motivated by such issues as unclear terminology when collecting or reporting data on trial retention issues (e.g. the meaning of the word 'withdrawal' itself), and available data being lost to a trial because of an assumption that data from routine healthcare visits cannot be used, when trial participants may not even have been consulted about their preferences.

 

We are aiming to develop high-level principles for how ongoing retention issues should be prepared for and handled in trials. We would then like to consult more widely (with members of the Trial Managers' Network, amongst other groups) on the acceptability of these principles, then release them to start a wider discussion and hopefully influence practice.

 

This webinar will cover the project background in more detail, give an update on the development of the high-level principles, and explain how you can give your feedback as part of the consultation.

 

Please note, you need to register for this event in order to receive an email invitation to join the session. We recommend that you view the webinar in a group with your colleagues, if you can, due to a limitation on the number of registrations. 

You will need access to web and sound facilities in order to view this webinar. 

A recording of the webinar will be made available after the event. All our members will be notified by email as soon as this is available. 

If you have any questions regarding this event, please email uktmn@nottingham.ac.uk