Soon, the European Union (EU) Clinical Trial Regulation No. 536/2014 will go into effect, requiring all sponsors, including academia, conducting clinical trials in the European Union to draft lay or plain language summaries for phase 2-4 clinical trials.
These lay summaries need to be published to the new Clinical Trials Information System that will be hosted by the European Medicines Agency (EMA) within 12 months from the close of each clinical trial. The regulation will become applicable 6 months after the European Commission confirms that the Clinical Trials Information System is fully functional. “Any sponsor with a clinical study that is set to complete after the regulation goes into effect will need to be in compliance,” said Kasim McLain, Manager, Disclosure Services.
This complimentary lay summary whitepaper will explain:
- the ins and outs of lay summary writing,
- the importance of starting a pilot program,
- a checklist for lay reviewers, and
- strategic advice for becoming more transparent.