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Glossary

Lay Person Summary (of a clinical trial)

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The EU Clinical Trials Regulation 536/2014 (Article 37) requires sponsors to provide summary results of clinical trials in a format understandable to laypersons. These lay person summaries will be made available in the EU Portal and Database.

Other glossary definitions

C

Cost-Effectiveness

Cost-effectiveness is the ratio of the cost of a therapeutic or preventive intervention to a…

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I

Integrated summary of efficacy (or effectiveness) (ISE)

Comprehensive integrated analysis of the effectiveness of a study drug, recommended to be submitted to…

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