he objective of EMA’s ITF briefing meetings is to set the stage for scientific and regulatory discussions that relate to the development of new medicinal products and technologies.
The purpose of this meeting was to inform the IMI on the both RADAR projects, and to exchange thoughts on a number of items that are associated with remote measuring technologies and the development of digital endpoints. During the meeting RADAR-AD and RADAR-CNS consortium members explained our research objectives, study design, variables of interest for assessing disease and relapse and potential outcomes from both projects.
For example, in both projects signals are collected using RMTs that provide objective and useful information on participants’ daily lives. The consortium was interested in hearing the ITF’s view on the conditions under which this information could be utilised as a stratification method and/or as endpoints in clinical trials. Similarly, health wearables such as Fitbit and smartphones comprising a variety of sensors and apps are used by consumers in various studies. The consortium was eager to learn about the requirements that these devices need to meet in order to be accepted as accurately defining clinical outcomes. Finally, both the RADAR projects employ an open source platform (the RADAR-Base platform) for data collection with the RMTs and data exchange. Therefore, in the meeting it was also addressed which regulatory considerations should be taken into account if this platform was employed at a larger scale.
It is important for both RADAR projects to involve the EMA in these discussion at early phases of the projects. The purpose of this is two-fold: It helps the consortium to carve out a path that leads to the development of outcomes that can be implemented in practice, and it helps the EMA to know the recent developments that are taking place in the drug development field.
The RADAR projects’ leaders appreciate the feedback received from the ITF members during this meeting. Especially useful were the discussions on the medical device regulation, patient reported outcomes, and the ethics associated with these novel technologies.
In the following months the RADAR-CNS and RADAR-AD consortia will be working on implementing the advice that was received from the ITF members. By doing so the consortia aim to develop solutions for remote assessment of disease that are accepted by regulatory bodies and improve the lives of the patients.