The to-do list for clinical trial sponsors grows ever-longer. In the EU, a new Clinical Trial Regulation (EU No. 536/2014) will require trial sponsors to create plain language summaries of clinical trial results, which convey what happened and why in simple terms than at an average person of average literacy can understand.
How can scientists tasked with managing a clinical trial communicate most effectively with a general audience? Plain language summaries written for a public audience should use simple everyday language equivalent to a sixth to eighth grade reading level in the US.
But effective communication transcends merely identifying the appropriate literacy level and adapting content to meet it. Scientists drafting plain language summaries need to keep a myriad of guideline “dos” and “don’ts” in mind.
When drafting plain language summaries for clinical trial results…
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