The Use of Remote Monitoring Technologies: A Review of Recent Regulatory Scientific Advices, Qualification Opinions, and Qualification Advices Issued by the European Medicines Agency

Aims: Recently, the use of novel remote monitoring technologies (RMTs) in trials has
gained much interest. To facilitate regulatory learning, we evaluated qualification opinions
(QOs) and advices (QAs) and scientific advices (SAs) of the Committee for Medicinal
Products for Human Use (CHMP) to gain insight in the types of devices that are intended
to be used in clinical trials for supporting/submitting application for obtaining marketing
authorization (registration trials) and the main recommendations of the CHMP.
Methods: QOs, QAs, and SAs of the CHMP that assessed RMTs between 2013
and 2019 were eligible for our study. The following information was extracted from
the documents: year of advice/opinion, device and endpoints used, type of endpoint
(primary, secondary, exploratory, or safety), and main recommendations of the CHMP.
Results: In total two QOs, four QAs, and 59 SAs were included in our study (total of SAs
between 2013 and 2019 = 4,054). In the SAs, accelerometers to measure activity and/or
sleep parameters (n = 31) were the most frequently used devices, followed by mobile
applications (n=6) and glucosemonitoring devices (n=6). Usually, thesemeasures were
proposed as secondary or exploratory endpoints (n = 32). The main recommendations
of the CHMP were related to relevance of the (novel) outcome measure; validation;
precision, accuracy, sensitivity, and specificity; compliance; sampling interval; and data
handling and privacy.
Conclusions: Although there was a trend toward an increased use over time, the use
of RMTs in registration trials is still relatively rare. In the absence of formal European
regulatory guidance on mHealth technologies, insight in the main recommendations of
the CHMP may stimulate the use of novel RMTs in a regulatory context.