december,2022

01decTMRP Webinar: Will Cragg - Results of the PERSEVERE ProjectEvent-Type:Webinars

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Event Details

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TMRP Methodology webinar – presented by Will Cragg (University of Leeds) on behalf of the UKCRC Registered CTU Network

Results of the UKCRC Registered CTU Network’s PeRSEVERE project: providing a comprehensive, practical guide to handling withdrawal and other participation changes across all areas of trial conduct

In most clinical trials, some participants will stop or reduce their participation before it was originally due to end. Ethical and regulatory conventions address this possibility mainly through the well-established ‘right to withdraw consent’, but this does not fully address complexities such as how participation changes may vary in nature and extent, whose decision the changes are, and the limitations on types of changes in a given trial. Variation in understanding and implementing these nuances can and does lead to untoward impacts on trial validity and participants’ rights.

The PeRSEVERE project (PRincipleS for handling end-of-participation EVEnts in clinical trials REsearch) is a collaborative UKCRC Registered CTU Network initiative, aiming to develop high-level principles to guide how clinical trials are set-up and conducted in light of these complexities. Our final, comprehensive set of guiding principles aims to exhaustively address all areas of clinical trial conduct, with overarching principles to support more detailed recommendations.

In this presentation, we will summarise the main ethical and practical outputs from the project, and talk through the practical steps those running clinical trials can take to ensure participation changes are managed in the best interests of participants and the trials they take part in.

Time

(Thursday) - Irish Standard Time, UTC +1

Location

Microsoft Teams

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