AstraZeneca Takes an Innovative Approach to Trial Results SummariesBy 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.