With the end of 2021 and the Christmas season approaching, I am writing to express my gratitude and to congratulate you on your contributions and achievements over the past 12 months. It has been a real pleasure and privilege to work with this amazing consortium.
Despite the intensely challenging circumstances, you have once again pursued the project activities with dedication, flexibility and to very high standards. As the project progresses, the interactions between different partners and work-packages become more and more complex, and in response you have built more effective partnerships and communications across the consortium. I know that effective partnerships, working and communication will be even more important as we look forward to the start of the Clinical Validation Study (now renamed Clinical Observation Study (COS)) in 2022.
Special thanks must also go to our Patient Specialist Advisory Board (PSAB). We also extend our warm welcome to Jean, Ulli and Werner for joining our PSAB this year. They continue to spend numerous hours of their own time to support our project at many levels and their contributions hugely important to our success. Similarly, we are grateful for the contribution of our Scientific Advisory Board and Ethical and Legal Advisory Board.
To date, we have completed 18 deliverables and reached 21 milestones, most of which were achieved on time or with just a short delay. The IMI office has accepted our first periodic scientific report in full and they were satisfied with our progress. Our key achievements in 2021 are summarised below. These are listed according to the lead WP but all WPs play an important role in these achievements. There are also many ongoing work that I have not included here for brevity.
In WP2, we have completed over 80% of the recruitment for the Feasibility Study (FS) in time despite the second wave of Covid-19 pandemic being at its peak, enabling us to generate valuable data to prepare our briefing document for submission to the European Medicines Agency (EMA) for qualification advice. We have set up a Patient Involvement and Engagement (PIE) group, in addition to the existing Patient Specialist Advisory Board, to broaden our Patient Involvement and engagement (PPIE) activities and linking such activities to the whole consortium. We have carried out qualitative studies to inform the development of the COS protocol.
In WP3, we have developed device-training materials (video and written) for the digital technologies that we have used in our FS. We have developed a set of comprehensive and transparent criteria for making recommendations for digital technology selection for the COS. We have developed a well thought-through strategy for device procurement for the COS, balancing cost and efficiency.
In WP4 and WP7, we have developed many data analytic pipelines, and within an extremely tight timeframe to complete an initial analysis of the FS data to support our EMA submission, as well as playing a key role in the preparation of the briefing document. Together with WP9, we have also organised an IDEA-FAST Science Showcase event to disseminate the results to the whole consortium and our Scientific Advisory Board.
In WP5, we have developed the IDEA-FAST Data Management Platform and application programming interface (APIs) as well as created data standards for the project.
In WP6, we have developed the first version of the COS protocol and have obtained research ethics approval at the lead site in Germany. We are now preparing ethics approval submission at other study sites.
In WP8, we have made critical contributions to the COS protocol development with regard to ethics, data protection and legal considerations.
In WP9, we have submitted our briefing document to the EMA in September with regard to our proposal for the development of digital endpoints for fatigue and sleep and we will be meeting with the Committee for Medicinal Products for Human Use (CHMP) in Feb 2022. In collaboration with MOBILISE-D, we have established the Digital Health Catalyst, bringing together the two large EU IMI consortia in digital endpoints to identify areas of synergy and to support future development in this research area. We have interacted with the Health Technology Agencies in Europe and work closely with NeuroNet. We have set up a monthly forum in improve communications and interactions among the whole consortium.
Last but not least, I must also thank Dave Wenn, Mike Jackson, Sofia Jacob and Sara Badreh for their amazing support in project management.
Looking ahead, our key foci for 2022 will be the EMA Qualification Advice meeting, COS study, completion of the FS data analysis and dissemination of our project results. We are currently planning our next General Assembly in late March 2022 which will include an investigator meeting for the COS. Our hope is that it will be an in-person meeting in Barcelona, but of course it will be dependent on the Covid-19 situation and we will provide an update in the new year.
Finally and more importantly, may I wish you a very happy Christmas/festive season and prosperous 2022.
(and on behalf of Walter, Yannis and Patricio)