By Darcy Grabenstein, Senior Manager of Content Strategy, Pharma Intelligence
According to a go-live plan released in October by the European Medicines Agency, its new Clinical Trial Information System (CTIS) is on track to launch Jan. 31, 2022. Along with the new registry portal comes application of European Clinical Trial Regulation (EU-CTR) 536/2014, which specifies what documents must be disclosed on the portal and when. The European Medical Writers Association (EMWA) cites that plain language summaries (PLS) of clinical trial results, “following health literacy and numeracy principles, will also need to be posted on the portal, detailing in lay language how the trial was conducted and its results.” Additionally, the UK’s Health Research Authority (HRA) requires a PLS within 12 months of study completion for trials with sites in the UK that end on or after Sept. 15, 2021.
Given that writing PLS can be a lengthy undertaking — especially if translations or a patient review panel are called for — sponsors would be well advised to start the process now. “Sponsors should not be caught unaware of what goes into this process,” says Courtneay Parsons, Head of Plain Language Summaries at ClaritiDox. “You’re not going to just sit down at a laptop, start writing, and be done a few days later.”