Last month RADAR-CNS took part in The Foundation for the National Institutes of Health (FNIH) Biomarkers Consortium’s public meeting titled ‘Remote Digital Monitoring for Medical Product Development Workshop’.
RADAR-CNS Project co-leads Professor Matthew Hotopf, King’s College London, and Vaibhav Narayan, Janssen Pharmaceutica NV, attended, alongside Dr Amos Folarin, King’s College London & South London and Maudsley NHS Foundation Trust and member of work package 7 (Devices and Platform).
They presented a case study on the Remote Assessment of Disease and Relapse in Major Depressive Disorder (RADAR – MDD).
Dr Amos Folarin, said, “It was exciting to see such an imaginative set of applications of remote monitoring applied to a diverse range of disease and hear about new data sensing modalities in development. This meeting was also a timely reminder of the need for a new regulatory framework that can cater to the complexity of the remote monitoring domain. Key regulatory issues were highlighted around establishing appropriate gold standards, black-box algorithms, and ephemeral nature of software components in the data acquisition apparatus.”
Their presentation is available online.
The use of digital health technologies has gained interest from consumers, providers, and researchers as a new way to improve therapeutic research and development (R&D). The workshop, in Bethesda, Maryland, US, addressed challenges and opportunities in the use of remote sensing technologies for improving the probability of success of therapeutic clinical trials. Important characteristics of tool development in this growing digital landscape were addressed in a series of case studies, presentations and open panel sessions.
The planning team will incorporate the insights and proceedings of the Workshop into a white paper and related manuscript that can be used to develop operational and regulatory guidance.
Videos from the workshop will be available here.