Saturday, November 18, 2017

23.07.2017 The results from clinical trials are usually discussed within the scientific community only and are seldom spread to the general public.

With the release of the EU Clinical Trials Regulation 536/2014 in 2014, informing the public about clinical trial results will become mandatory in Europe.

Lay language summaries intend to improve the transparency of clinical research in general and may help to return results of clinical trials to the patients concerned. Once the EU Regulation 536/2014 enters into application, Lay Language Summaries will need to be released within 1 year after operational completion of a clinical trial.

On 2 May 2017, the European Forum for Good Clinical Practice (EFGCP) and the European Federation of Pharmaceutical Industries and Associations (EFPIA) in partnership with large patient organizations conducted a workshop, Communicating clinical trial results to meet public needs: Working towards implementation of Lay Summaries, with stakeholders from patient and consumer health organizations, regulatory authorities, pharmaceutical industry and academia to discuss and develop best practices for implementation of Lay Summaries.

The report of the workshop is now out and can be downloaded here:

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