Guidance for using endpoints in joint clinical assessments (JCA)

The European Commission has published a comprehensive guide for using outcomes in joint clinical assessments (JCA) as part of Health Technology Assessments (HTA). The guide, which was adopted on June 10, 2024, aims to standardize and improve the selection and reporting of clinical outcomes for JCAs.

Joint Clinical Assessments (JCA) are defined under the EU Health Technology Assessment Regulation (HTA) as: the scientific compilation and description of a comparative analysis of available clinical evidence on a health technology compared to one or more other health technologies or existing processes.

Key features of JCAs are:

- They focus on the comparative analysis of clinical effectiveness and safety.

- They make no value judgments or conclusions about additional clinical benefits.

- The results are not binding on Member States.

They should reduce duplication of work and harmonise HTA methods in the EU.

The guide first defines important terms such as outcomes, outcome measurements, and effect measures. He categorizes outcomes according to their source of information into clinically reported, patient-reported, observer-reported, and digital outcomes. Particular attention is paid to the clinical relevance of outcomes, with a preference for patient-centered and long-term outcomes. The guide recommends using Core Outcome Sets (COS) as a guide when selecting relevant outcomes, but underlines that the final decision lies with the individual Member States.

An important aspect of the guide is the treatment of surrogate endpoints. These should only be used when direct patient-centered outcomes are not available and their validity has been clearly demonstrated. The guide describes various levels of evidence for validating surrogate endpoints.

The guide provides detailed instructions for reporting in JCAs. Outcomes should be precisely defined and reported with baseline values. All pre-specified analyses must be reported to avoid selective reporting. Possible distortions in outcome reporting should be made transparent.

Overall, the guide aims to improve the quality and consistency of JCAs by providing clear guidelines for selecting, measuring, and reporting clinically relevant outcomes.

This should ultimately contribute to better-informed decisions in healthcare. It can be assumed that similar efforts will be made for medical devices.

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Source and detailed information: https://health. ec.europa.eu/document/download/a70a62c7-325c-401e-ba42- 66174b656ab8_en?filename=hta_outcomes_jca_guidance_en .pdf (delete space for link)

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