News
The RADAR-AD consortium publishes a paper which reviews EMA’s recent scientific advices and opinions for RMTs
Within the RADAR-AD consortium Lygature is responsible for the project management, communication about the study and dissemination of its results to relevant stakeholders, as well as communications with regulatory authorities, patient associations, payers and ethical boards. In this capacity Lygature co-leads RADAR-AD’s regulatory work stream which focuses on interactions with regulatory authorities, Health Technology Assessment bodies and payers. The purpose of this work is to develop a roadmap towards qualification for the use of remote monitoring technologies (RMTs) in collecting relevant information about Alzheimer disease (AD).
The most recent RADAR-AD article presents a review of the advices and opinions (i.e. qualification opinions, qualification advices and scientific advices) provided by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). The authors conclude that, although there is a trend towards an increased use of RMTs over time, their use in registration trials (a type of research study) is still relatively rare. This type of work can provide a better understanding of the EMA’s requirements regarding the use of RMTs in clinical trials for AD. Most importantly, taking these recommendations into account could contribute towards a more optimal development of RMTs which are acceptable for regulatory agencies, and might also indirectly benefit people living with AD and their supporters/carers.
Pieter Stolk – Program Manager at Lygature and sub-lead of the regulatory work in RADAR-AD, comments:
“The paper is the first one to review EMA Qualification Opinions, Qualification Advices and Scientific Advices that were requested for RMTs. Although there is still quite limited data in only a number of specific areas, the study shows some interesting themes in the recommendations from CHMP which developers should consider carefully. There was a limited number of documents we were able to analyze and this is logical. This is very much an area that is undergoing rapid evolution. Therefore, it would be great to do this study again in one or two years’ time and see what trends can be discerned. Also, we could then see how EMA is responding to much more diverse types of RMTs in different therapeutic areas.”
The publication
Title
The use of remote monitoring technologies: a review of recent regulatory scientific advices, qualification opinions and qualification advices issued by the EMA
Authors
Marieke J.H.J. Dekker, Pieter Stolk, Anna M.G. Pasmooij, on behalf of the RADAR-AD Consortium
Available here.
Summary
The use of remote monitoring technologies (RMT) in research studies (exploratory work in certain disease areas, and e.g. in clinical trials) is gaining interest. The article provides an analysis of the review of three different types of documents issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). These include: Qualification Opinions (QO), Qualification Advices (QA) and Scientific Advices. The QO refers to the issued opinion on the acceptability of the specific use of a method, such as the use of a novel methodology in the context of research and development. The QA refers to the issued advice on protocols and methods that are intended to develop a novel method with the aim of moving towards qualification.
The authors of the article analyzed existing QOs, QAs and SAs related to RMTs. In particular, in these documents, they looked at: the date (year) of the advice/opinion, the device and endpoints (outcome measure) used, the type of endpoint and the main recommendations of the CHMP.
Results
The most frequently used devices were:
- accelerometers (tools that measure movement of the body i.e. to measure sleep and activity),
- mobile applications measuring cognitive functioning (memory),
- glucose monitoring devices which measure glucose continuously e.g. in the case of diabetes.
The main recommendations of the CHMP were related to:
- relevance of the outcome measure (what is measured by the RMTs, or for instance glucose or sleep activity),
- validation (the confirmation that RMTs are fulfilling their role and that what they measure is relevant for the person),
- precision, accuracy, sensitivity and specificity,
- compliance,
- sampling interval (the time between two measurements)
- data handling and privacy.
Conclusion
Although there is a trend towards an increased use of RMTs over time, their use in registration trials (a type of research study) is still relatively rare. Insight into the main recommendations of the CHMP may stimulate the use of novel RMTs in a regulatory context. This is relevant given the absence of formal European regulatory guidance on m-Health (mobile health) technologies, except for a recent Q&A document, used for the purpose of collecting data and information, and providing health services.