The Commission has published a guidance document on the validity of clinical studies for joint clinical assessments under the EU Health Technology Assessment Regulation, adopted by the Member State Coordination Group.
This guidance helps to define, classify, and assess the certainty of clinical study results in an objective, reproducible and transparent way. It covers the analysis of data from different types of single clinical studies.
This guidance complements the guidance documents previously adopted by the Member State Coordination Group on outcomes for joint clinical assessments, on quantitative evidence synthesis for direct and indirect comparisons and on reporting requirements for multiplicity issues and subgroup, sensitivity and post hoc analyses in joint clinical assessments.
The Member State Coordination Group on Health Technology Assessment adopted the new guidance document at its 10th meeting on 19 September 2024.
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