ROADMAP’s activities are progressing well and this article was drafted in collaboration with all ROADMAP Work Packages (WPs) to give you an outline of recent activities and developments. To access interviews with the WP/topic leaders click on the names of the respective WPs.
The Management and Coordination team (WP1), has been providing ongoing support to all partners where necessary. Further, it recently submitted deliverables D1.3 – the initial Knowledge and Management Plan – and D1.4 – the periodic report for the Innovative Medicines Initiative. In addition, it is coordinating the 6th General Assembly Meeting (GAM) which will take place in October.
ROADMAP colleagues from the Outcome Definition team (WP2), are preparing a publication on what outcomes are important to people with Mild Cognitive Impairment or Alzheimer’s disease (AD), their carers and healthcare professionals. Further, as an addition to D2.3 the Stakeholder-generated lists of priority real-world evidence (RWE) relevant outcomes for AD, they recently submitted a supplement entitled: “Priority AD-outcomes from Health Technology Assessment (HTA) and regulatory agencies”. The team is also about to submit a manuscript for publication reporting the findings of their recently completed systematic literature review. Other publications are also in preparation, revolving around outcome prioritisation and meaningful disease progression delay across the AD spectrum. Finally, the team submitted deliverable D2.4, the Real World Evidence progression marker and outcome classification matrix for AD.
The Real World Evidence (RWE) identification team (WP3), have assembled writing teams and started to work on deliverable D3.3: “Update on potential data sources with real-world evidence (RWE) data in Europe”. Also, they are working with the teams from WP4 and WP5 regarding ongoing data requests. Further, they are collaborating with the teams from WP2, WP4, WP5 and WP6 to refine the data cube outcome measure definitions. Fingerprinting of several additional cohort data is ongoing and will contribute to D3.3 and the data cube.
The Disease Modelling and Simulation team (WP4), are identifying the people who will be involved in the data analysis for each model validation. Discussions on the challenges in validation are being shared.
- Measuring quality of life of people with predementia and dementia and their caregivers
- Resource utilisation and costs in predementia and dementia
- Methodologies and data sources of existing economic models across the full spectrum of Alzheimer’s disease and dementia from apparently healthy through disease progression to end of life care
The Regulatory and Health Technology Assessment (HTA) team (WP6), recently submitted a publication on the main regulatory and HTA considerations for a disease-modifying drug in AD. The next face-to-face Expert Advisory Group (EXAG) meeting date is currently being discussed. Lastly, the team also circulated a questionnaire to evaluate the operation and impact of the EXAG, to the ROADMAP Consortium.
Finally, the Ethical, Legal, and Social Implications (ELSI) team (WP8), have recently submitted their paper about the justifications for different kinds of clinical trial data sharing and are collaborating with the Outcome Definition team on a paper about the ethics of outcome prioritisation for Deliverable D8.4. The systematic review on the ethics of predictive modelling for secondary AD prevention is progressing well. Lastly, they are also working on a paper reporting the results of the ELSI focus groups.
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