FIGON-DMD 2019
On the 23rd of September 2019 the RSNN hosted a session during the FIGON Dutch Medicines Days in Leiden. The session was chaired by Peter van Meer (assessor at CBG-MEB, vice-chair RSNN) and Joop van Gerven (chair of the CCMO).
In four presentations (see below), followed by a plenary discussion, current developments in monitoring and measurement technologies for clinical research were discussed. Furthermore, speakers debated on opportunities for optimizing the value of innovative technologies for medicines development and regulatory decision-making. Ultimately, the discussion explored the implications for regulatory and HTA assessment with a special focus on the acceptability of new methods for evidence generation.
In conclusion, the use of innovative monitoring technologies requires a new regulatory framework. There is no doubt about the benefit of early interactions between developers, clinicians and regulators at the design stage of new clinical trials, as well as early interaction between different agencies at the EU and national level and regulators focussed on the use of algorithms, big data analysis methods and advanced technologies. A thorough assessment on how to achieve these early interactions and what benefit they can bring exactly is a topic for future regulatory science. In addition, research needs to focus on the obstacles and barriers preventing alignment of regulatory decision making with the current technology push (e.g. wearables, remote monitoring, mHealth). A better understanding of the technical aspects of these new technologies and their considerations for use in clinical trials is key to make further progress.
“Devices for remote monitoring bring in an entire new complexity to judging drug efficacy and therefore it is important to close the knowledge gap between existing and new technologies.” (Peter Mol, principal assessor at CBG-MEB and member of EMA’s Scientific Advice Working Party)
The full report of the meeting can be downloaded here.
You can also download the following presentations:
- Adoption of digital endpoints and telemedicine in clinical trials (Matthijs Kruizinga)
- Microsampling to enable home-based drug monitoring (Tom Zwart)
- Qualifying novel tools to monitor drug effects in clinical trials: experiences and the role of the regulator (Peter Mol)
- Downstream effects of acceptance of uncertainties at approval of medicines (Lourens Bloem)