There is a lot happening across the ROADMAP project and this article was drafted in collaboration with all ROADMAP Work Packages (WP’s) to give you an outline of recent activities and developments. The success of a project like ours relies on good communication, coordination and passionate members striving towards a common goal – improved healthcare.
This article follows our WP structure WP1-WP8, for easier overview check out our project structure.
The Management and Coordination team (WP1) has been providing ongoing support to all partners where necessary. Further, it currently organises the 5th General Assembly Meeting taking place on April 25-26.
ROADMAP colleagues from the Outcome Definition team (WP2) convened a data synthesis meeting on 22 March to develop a consensual plan in order to integrate the information from their various activities. They recently closed their online survey, paper surveys are currently being distributed in memory clinics in Oxford (UK) and Girona (Spain) until the end of April. They also recently submitted the deliverable of their systematic literature review entitled “D2.2 Report of systematic review of published and unpublished data identifying important and relevant outcomes in Alzheimer’s disease (AD) and criteria for disease progression” to the Innovative Medicines Initiative.
The Real World Evidence (RWE) identification team (WP3) are currently preparing for the deliverable “D3.3 Update on potential data sources with real-world evidence (RWE) data in Europe”. Further, they are collaborating with the model validation team to define a final selection of datasets and discuss the Data Cube population.
- Results for the Mini Mental State Examination model (Handels model) are available for the Integrated Primary Care Information database (IPCI), SIDIAP, Memento, Gothenburg cohorts and EDAR.
- Memento was identified as the preferred data source to validate the pre-clinical model (Novartis). The “Transparent Reporting of a multivariable Prediction model for individual Prognosis or Diagnosis” (TRIPOD) checklists were filled in and scripts for model validation are under development.
- TRIPOD model development checklist is filled in for the PENTAG institutionalisation model (Lilly). External datasets for validation are currently being discussed.
- Measuring quality of life of people with predementia and dementia and their caregivers
- Resource utilisation and costs in predementia and dementia
Further, they organised a workshop on 14th February 2018 in Paris, with external advisors. You can read about the workshop here. This workshop was back-to-back with the International Pharmaco-economic Conference on Alzheimer’s Disease (IPECAD) conference at which three members of the ROADMAP team gave presentations:
- ‘Real-world evidence in Alzheimer’s disease: the ROADMAP collaboration’ from Pieter Jelle Visser (WP3 co-lead),
- ‘Swedish registry data (Svedem, Gothenburg biomarker registry)’ from Ron Handels (WP3), and
- ‘Overview of health economic modeling approaches in Alzheimer’s disease’ from Anders Gustavsson (WP2).
The Regulatory and Health Technology Assessment team (WP6) completed the first draft of a manuscript reflecting on main regulatory and HTA considerations for a disease-modifying drug in AD, under deliverable D6.3, and have organised the third Expert Advisory Group (EXAG) teleconference, which took place on February 26th. The next face-to-face EXAG meeting will be arranged for June/July.
The Communication team (WP7) produced the fifth external newsletter (circulation 24th April). In addition, as part of the internal communication on ROADMAP goals and milestones, the team shared the second ‘EFPIA partners Newsletter’ with representatives of partner companies for internal circulation with industry leaders and team members. The EFPIA partners Newsletter is intended to give a high-level update on where we are with ROADMAP and next steps. The team is currently conducting interviews with WP leaders to enrich the website with basic background information.
Finally, the Ethical, Legal, and Social Implications (ELSI) team (WP8) are progressing well with the analysis of the consultation with the European Working Group for People with Dementia (EWGPWD) where they explore concerns raised by sharing health data to create a RWE platform for AD research. A first draft is underway. In addition, the team is currently working on a systematic literature review “the ethics of predictive modelling for AD secondary prevention” (as part of their upcoming Deliverable D8.5 Final report on requirements for ELSI framework for a RWE approach in AD). The protocol for this has been submitted to PROSPERO.