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Joint EFGCP-EFPIA Multi-Stakeholder Workshop on

Communicating Clinical Trial Results to meet Public Needs - Working towards Implementation of Lay Summaries

2 May 2017, Crowne Plaza Le Palace, Brussels, Belgium

Organised by EFGCP and EFPIA

Returning results of clinical trials through Lay Language Summary (LLS) to patients involved in a clinical trial has obvious merits and challenges. With the release of the Clinical Trial Regulation in 2014 informing the public about clinical trial results has become mandatory to improve the transparency of those trials.

In May 2015, just after the release of the Clinical Trial Regulation, EFGCP explored in a workshop with all concerned stakeholders how it could be possible to make clinical trial results available in lay language, whether at the individual participant level through the trial investigator or by posting aggregate results onto a webpage. Both options provide opportunities and pose some practical challenges.

Since then, experience has been growing in Industry and academia, and a specific European guideline on Summaries of Clinical Trial Results for Lay Persons has been drafted by the UK Health Research Authority on behalf of the EMA/EU Commission. While acknowledging that the public is expected to be the primary audience for the lay summaries, the guideline will provide sponsors with appropriate recommendations and templates to help them releasing appropriate and useful LLS.

Today in 2017, while waiting for the implementation in Europe of the Clinical Trial Regulation, EFGCP has agreed to organise a second workshop with experienced speakers, to understand what progress has been made. The currently proposed workshop will be the opportunity to understand how sponsors are coping with the implementation of LLS, to share experience and best practices, and understand whether the expectations of all the stakeholders including patientsí and public representatives, have been addressed. Through presentations, and panel discussions, this workshop will investigate how regulators are preparing Europe for LLS, the impact beyond Europe, and what constitutes an appropriate LLS.

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