Medical Writing Patient-reported outcomes Protecting the rights of clinical trial patients through disclosure: The significance of plain language
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Volume 27, Issue 4 - Patient-reported outcomes

Protecting the rights of clinical trial patients through disclosure: The significance of plain language

Abstract

Taking a step back to understand the history of clinical trial regulation triggers a broader perspective on the work we do or the work we will do. As regulatory medical writers, our role is often limited to the more technical
submission-level component of either a trial design or a trial outcome. With the advent of plain language summaries (also known as patient lay summaries), we have a unique opportunity to inform the clinical trial patient population directly, and in turn the wider public audience.

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