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 article follows our WP structure WP1-WP8, for easier overview check out the project structure.
The Management and Coordination team (WP1) has been providing ongoing support to all partners where necessary.
On Monday 15th January 2018, an international group of 18 ROADMAP collaborators from academia, industry and a patient organisation joined a workshop convened by Edinburgh University for the Outcome Definition team (WP2). They discussed data synthesis for the Systematic Literature Review (SLR) under Deliverable 2.2. Led from Edinburgh University, the group explored the evidence base, looking at the findings identified in response to the SLR’s two research questions. The relative importance of patient-reported outcomes was emphasised, as was the synergy with the universe of outcomes published in ROADMAP Deliverable 2.1 and the need to carefully report on the robustness of included studies. The group developed a draft structure and approach to interpreting and synthesising the evidence, which will be taken forward to create the final report by the end of February.
The Real World Evidence (RWE) identification team (WP3) added fields in the European Medical Information Framework-Alzheimer’s Disease (EMIF-AD) catalogue to the data cube to adapt it to ROADMAP needs and refine the current outcomes fingerprinted. They have developed a working document with potential Alzheimer’s disease (AD) cohorts for the validation studies being carried out under WP4. They have also gained access to Memento and Gothenburg cohorts for the WP4 validation studies, and efforts to identify and gain access to other data cohorts are ongoing. Finally, they are working towards making Lilly clinical trial (CT) placebo data available through hosting at EMC’s database.
The Disease Modelling and Simulation team (WP4) selected three models for validation. The first is a Mini Mental State Examination model (Handels model), the results of which are available for the Integrated Primary Care Information database (IPCI). Data extraction is ongoing from SIDIAP (Information Systems for Research in Primary Care), Dementia Platforms UK (DPUK), Memento, and discussions are ongoing regarding the inclusion of University of Gothenburg cohorts. The second model is the pre-symptomatic model (Novartis), for which the Memento, Amsterdam, and Gothenburg cohorts have been identified. The Transparent Reporting of a multivariable Prediction model for individual Prognosis or Diagnosis (TRIPOD) checklist has been completed for use with the NOVARTIS model. The third model is the PENTAG institutionalisation model (Lilly), for which the TRIPOD model development checklist has also been completed.
The Health Economics team (WP5) organised a forthcoming workshop on 14th February 2018 in Paris, with external advisors, and which will be back-to-back with the International Pharmaco-economic Conference on Alzheimer’s Disease (IPECAD) conference taking place immediately after:
“Modelling the economic value of Alzheimer’s Disease interventions: How far have we come, and what next”. Members of the ROADMAP team will attend the conference to give three 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 6.3, and have organised the third EXAG teleconference, which will take place on February 26th.
The Communication team (WP7) recently produced the fourth external newsletter, which was circulated on 11th January, and has added a new video section on the ROADMAP website. They had face-to-face discussions with Big Data for Better Outcomes (BD4BO) colleagues from BD4BO’s Work Package 3 and other disease specific project representatives (Harmony & BigData@Heart) on 16th January in Brussels at the offices of the European Federation of Pharmaceutical Industries and Associations (EFPIA). In addition, as part of our internal communication on ROADMAP goals and milestones, WP7 shared the second ‘EFPIA partners Newsletter’ with representatives of partner companies for internal sharing with their 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.
Finally, the Ethical, Legal, and Social Implications (ELSI) team (WP8) held a consultation on 7th December 2017 with the European Working Group for People with Dementia (EWGPWD) to explore concerns raised by sharing health data to create a RWE platform for AD research, and have completed a first draft of the protocol for the systematic literature review on the ethics of predictive modelling for secondary prevention of AD, under Deliverable 8.5.