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European Commission: Health Technology Assessment -Guidance on Outcomes for Joint Clinical Assessments and Reporting Requirements

The European Commission has recently published two new guidance documents on Health Technology Assessment (HTA), dated June 13, 2024. These documents aim to enhance the evaluation and implementation of health technologies across Europe, ensuring they are both effective and beneficial to patients.

Health Technology Assessment (HTA): A systematic evaluation of the properties and impacts of health technologies, considering their medical, social, economic, and ethical implications.

HTA plays a crucial role in making informed decisions about the introduction and use of health technologies, such as medical devices, pharmaceuticals, and diagnostic tools.

Clinical outcome assessments (COAs), used in clinical studies (whether they are interventional (also called experimental), or observational), are a key component of health technology assessment (HTA). The guidance on outcomes for joint clinical assessments will help:

  • Member States’ authorities define the scope of the assessments

  • assessors report all the elements that Member States need for the national appraisal of the clinical added value of health technology. 

The guidance on reporting requirements for multiplicity issues and subgroup, sensitivity and post hoc analyses in joint clinical assessments describes how:

  • assessors should deal in practice with multiplicity issues and complementary analyses in joint clinical assessment (JCA) reports. 

These approaches influence how various Member States address specific methodological issues. Thus, the guidance will help Member States draw their conclusions on these analyses at the national level.

Both guidance documents are essential for health technology developers in preparing the appropriate analyses and information for submission to the assessment.

The Member State Coordination Group on Health Technology Assessment adopted the two guidance documents at its 9th meeting on 10 June 2024. For more detailed information, you can access the full guidance documents here.


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