Work Package 5 - Life cycle approach to improve Evidence Generation
Work package 5 will bridge the gaps between patients, caregivers, technology developers, current registry holders, authorities in the health care sector, HTA producers and HTA users. Its main objective is to help generate the right evidence all along the technology life cycle and, where further evidence generation is required, develop tools that support the collection and use of high quality data that is relevant to the range of organisations and stakeholders.
This Work Package consists of two strands:
Strand A: Early dialogues (initial evidence generation), and
Strand B: Post-Launch Evidence Generation and Registries.
Deliverables from Early Dialogues - Strand A:
- Develop and establish an organizational structure for Early Dialogues
- Evaluate how the collection of fees from industry and the redistribution among partners could best be implemented. Furthermore, evaluate how the actual agreement between industry and EUnetHTA partners could be set up.
- Deliver 33-35 Early Dialogues
- Develop and implement a financially sustainable system for delivering EDs.
Post-Launch Evidence Generation and Registries - Strand B
• “full”pilots will be initiated by HTA bodies, following the identification of evidence gaps in an HTA report. The pilots will consist in producing a common research question and minimum data set for registries, and, if possible, a definition of a core common protocol.
• “collaborative” pilots will be initiated by other bodies/projects. Involvement will mainly consist in complementing the initial request with HTA bodies’ requirements.
- PLEG tool:
how to insure that good quality data is collected, and how to later best use data gathered from PLEG, especially registries, all in order to make permanent PLEG collaboration operational.
Milestones Early Dialogues - Strand A :
- Scenarios for Early Dialogue funding
- Conduct early dialogues
- Fee-for-service system: decision and implementation
- Launch and testing of the new funding model, proposal for permanent activity
Milestones – Post-Launch Evidence Generation and Registries – Strand B
- Standards for registers in HTA tool - Candidate registers and participating HTA agencies identified.
- Report on current processes for using register data in HTA assessments in European HTA agencies.
- Start of pilots
- Identify options for a mechanism for independently accrediting or assuring registers using the Quality Standards for Registers in HTA, including updating the standards in line with methodological developments.
- Tool for Registers in HTA prepared.
- Post Launch Evidence Generation, start of last pilots
Options for a business model for ongoing delivery of a mechanism for independently accrediting or assuring registers using the Quality
- Standards for Registers in HTA, including updating the standards in line with methodological developments.
- Post-launch evidence generation tool produced