A Pilot Study to Explore Length and Readability Characteristics of Subject Information Sheets/Informed Consent Forms of Clinical Trial Applications in the EU.

Clin Transl Sci · 2026 · PMC13136066 · PMID 42071174

Europe PMC DOI

hedged sentence

0.0600

closest p · 1.2× alpha

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boldest claim

The sentences

showed a trendp = 0.06so close (0.05 < p ≤ 0.1)

Trials with rare disease designation showed a trend toward longer SIS/ICFs (mean difference 5.3 pages, 95% CI: 0.2–10.8; p = 0.06).

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