Surrogate outcome decision support tool
A web-based tool designed to help health technology assessment (HTA) agencies and payers decide how to handle evidence from surrogate endpoints, like lab results or biomarkers, when evaluating medical treatments. It supports more informed decisions when direct evidence on patient outcomes is not available.
At a glance
Use when
Evaluating new treatments with early or limited clinical data, especially when surrogate endpoints are the primary evidence source
Avoid when
Direct evidence on patient-relevant outcomes is available, or when the surrogate-clinical outcome link is weak or unproven
Inputs
Information on the surrogate endpoint, clinical context, strength of evidence, regulatory status, and disease characteristics
Outputs
Guidance on the appropriateness and limitations of using surrogate endpoint evidence in decision-making, including recommendations for evidence development and uncertainty management
How it works
The tool was developed based on findings from four empirical studies within the COMED program and integrates insights from international HTA practices and methodological literature on surrogate endpoints. It provides a structured framework to assess the validity and relevance of surrogate endpoint evidence in the context of HTA, supporting decision-making under uncertainty.
- Project
- COMED
- Funding
- Horizon 2020
- Project status
- Completed 2021
- HTA domains
- Clinical Effectiveness
- Categories
- Surrogate Endpoints
- Technology
- Medical Devices
- Assumptions
- The surrogate endpoint is biologically plausible and has some established correlation with clinical outcomes; long-term outcome data are unavailable or immature; decisions must be made under time pressure
- Strengths
- Based on empirical research and international HTA practices; supports structured, transparent decision-making; designed for use by diverse HTA stakeholders including clinicians, patients, and manufacturers
- Limitations
- Does not replace clinical trial data; utility depends on user interpretation; limited validation data so far; not a standalone approval tool
- Also known as
- Surrogate Endpoint Decision Tool, COMED Surrogate Outcome Tool
Questions this answers
- › When is it appropriate to use surrogate endpoints in health technology assessments?
- › How reliable is a surrogate endpoint for predicting actual patient outcomes?
- › What factors should be considered when deciding to approve a treatment based on surrogate evidence?
- › How do different HTA agencies currently handle surrogate endpoint data?
- › What are the risks of making funding decisions based on surrogate outcomes?
- › Can this tool help compare surrogate-based evidence across different technologies?
Similar by meaning
Beta record. Generated from the primary source via AI extraction and independent audit, pending final human review.