Clinical Trials, Technology

AstraZeneca Takes an Innovative Approach to Trial Results Summaries

By TrialScope

Trial results summaries, also known as plain language summaries (PLS) or lay language summaries, convey what happened during a clinical trial in easy-to-understand language.

Best practices dictate that PLS is written at a fifth- to eighth-grade reading level. What’s more, PLS must be available in the same language as the patient’s informed consent.

In the European Union (EU), a clinical trial regulation scheduled to go into effect in mid-2020 requires all sponsors with studies in the EU to provide PLS.

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