EUnetHTA 21 D4.4 Guidelines on Endpoints
These guidelines help standardize how clinical outcomes, including survival measures and patient-reported experiences, are chosen and used in joint health technology assessments across Europe.
At a glance
Use when
Conducting or reviewing Joint Clinical Assessments, especially when evaluating non-OS endpoints or PROs
Avoid when
Assessing technologies where endpoints fall outside clinical effectiveness or patient-reported experience domains
Inputs
Clinical trial data, study protocols, endpoint definitions, patient-reported outcome measures
Outputs
Standardized endpoint evaluation in JCAs, consistent interpretation of clinical benefit
How it works
Developed under the EUnetHTA21 project, these guidelines provide methodological recommendations for the selection and use of clinical endpoints—such as non-overall survival (non-OS) endpoints and patient-reported outcomes (PROs)—in Joint Clinical Assessments (JCAs) to ensure consistency, validity, and comparability across HTA bodies.
- HTA domains
- Clinical Effectiveness, Patient and Social Aspects, Aspects Beyond HTA
- Assumptions
- Endpoints are measurable, clinically meaningful, and reliably reported; access to high-quality trial data including PRO instruments and their psychometric properties
- Strengths
- Promotes harmonization across European HTA agencies; supports inclusion of patient-centered outcomes; provides clear criteria for endpoint validity
- Limitations
- May not cover all disease-specific endpoints; dependent on availability and quality of PRO data; limited guidance on handling missing endpoint data
- Also known as
- D4.4 Guidelines on Endpoints, EUnetHTA21 D4.4
Questions this answers
- › Which clinical endpoints are appropriate for use in Joint Clinical Assessments?
- › How should non-OS endpoints be evaluated and interpreted?
- › How can patient-reported outcomes (PROs) be reliably integrated into assessments?
- › What criteria ensure endpoint validity and relevance?
- › How can heterogeneity in endpoint selection across studies be addressed?
- › What are the implications of surrogate or intermediate endpoints for decision-making?
References & sources
Related methods
Similar by meaning
Beta record. Based on the original catalogue summary; primary-source enrichment pending.