- Published
- Updated
- Sources checked
A lay summary should let a non-specialist understand what happened, including uncertainty and unfavourable results.
CTR lay summaries — Define the regulatory scope
CTR Article 37 and Annex V establish the lay summary framework. The technical summary and lay summary need consistent evidence even though their language differs.
CTR lay summaries — Build the working record
Build a message table connecting each plain-language statement to the population, endpoint and analysis. Use absolute numbers where appropriate, explain missing data and distinguish group findings from advice to an individual.
CTR lay summaries — Check before release
- Check benefit and harm receive balanced treatment.
- Explain uncertainty without statistical shorthand.
- Ask non-specialist reviewers to describe their understanding.
CTR lay summaries — Record the decision and handover
Record review comments and reconcile every changed number with the technical result set. Publish the required summary through the applicable workflow; a journal abstract or marketing page is not a substitute.
Frequently asked questions
- Can a lay summary state that treatment is best?
- Only evidence-supported, appropriately qualified findings belong in it; avoid promotional ranking.
- Should inconclusive findings be omitted?
- No. Explain what can and cannot be concluded from the study.