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HTA Regulation: EU Publishes Guidance On Validity Of Clinical Studies For Joint Clinical Assessments

 
• By Francesca Bruce

Joint clinical assessment reports must be descriptive rather than reach definitive conclusions, and must not interfere with national decision making processes, according to new EU guidance.

Research
New guidance published on clinical study validity for EU-level JCAs • Source: Shutterstock

New guidance published by the European Commission aims to “define, classify and assess the certainty of clinical study results” that will inform the forthcoming EU-level joint clinical assessment (JCAs) in an “objective, reproducible and transparent way,” according to the commission.

The JCAs were introduced under the Heath Technology Assessment (HTA) Regulation and will be similar to member state-level relative-effectiveness assessments. They will bring big changes for companies that want to...

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