EMA update on Clinical Trials Information System

The European Medicines Agency’s (EMA) Management Board held its first meeting in Amsterdam on 21 March.  In meeting highlights released 22 March,  EMA provided the following update on the Clinical Trials Information System (CTIS): The Board was updated on the status of the ongoing development of the Clinical Trials Information System (CTIS – formerly the EU clinical trial portal…

UK Government position on clinical trial transparency

The UK government issued a policy paper on 22 February to improve clinical trials transparency in response to 10 recommendations a House of Commons Science and Technology committee report issued in October 2018. Importantly, in relation to lay summaries of clinical trials, the response to recommendation 1 states: ‘In the event of a negotiated agreement…

4th Annual Lay Summaries Summit 2019

Registration is now open for the 4th Annual Lay Summaries Summit, which will be held in Philadelphia on 25 and 26 September 2019. The agenda and speakers have yet to be announced. Lay Summaries Ltd look forward to being there!

Lay summary barometer

We’re running a survey to assess the awareness and preparedness of pharmaceutical companies to meet the impending regulatory change requiring trial sponsors to provide a summary of trial results understandable to a lay audience within 1 year of trial end. So far the average time to complete the survey is 1 minute 34 seconds! So…

Pregnancy risk lay summary

MBRRACE (Mothers and Babies: Reducing Risk through Audits and Confidential Enquiries across the UK) pregnancy risk lay summary MBRRACE have developed a really nice lay summary outlining the risks of pregnancy, risk factors, the importance of planning and knowing your own body, and factors related to mental health in pregnancy. Worth a read- available here: https://www.npeu.ox.ac.uk/downloads/files/mbrrace-uk/reports/MBRRACE-UK%20Maternal%20Report%202018%20-%20Lay%20Summary%20v1.0.pdf

Updates from the EMA on EU portal and database

A recent press release from the EMA has provided updates in relation to the EU Clinical Trial Regulation and development of the EU portal and database, which now look set to go live at some point in 2020: ‘The Board was updated on the quality and status of the ongoing development of the EU clinical trial…

3rd Annual Lay Summary Summit 2018

The 3rd Annual Lay Summary Summit recently took place in Philadelphia, US. The 2-day congress, organised by the CBI, covered topics such as the evolution of lay summaries, new developments in the field, pharmaceutical company perspectives on lay summaries, communicating trial results to patients, challenges and predictors of success in lay summary development, and the role…