E. Sala, PhD

Analyzing the debate around writing and constructing layperson summaries of clinical trial results-and proposing a “reader-centered” approach.

Outlining considerations on layperson summary writing of clinical trial results in Europe, and proposing a "reader-centered" approach to constructing these summaries.

In 2014, EU Regulation n.536/2014 represented a significant step toward transparency of clinical trials in Europe. However, despite the EMA’s policy 0070, which reinforced this concept, several aspects remain to be determined or evaluated, leaving room for additional requirements and local interpretation.