A new discussion channel called #dHealth4Trials is now open on the In Silico World Community of Practice, the online community devoted to the discussion of good practices on the use of in silico and digital technologies in the clinical practice and the regulatory evaluation of new drugs and medical devices.
Endorsed and supported by Mobilise-D, a project funded by the European Commission and various members of the European Federation of Pharmaceutical Industries and Associations (EFPIA) through the Innovative Medicine Initiative (IMI), the #dHealth4Trials channel will be a virtual space for discussion and exchange of good practices about the use of digital health technologies in regulatory clinical trials for the safety or efficacy evaluation of new drugs or new medical devices.
The discussion around the use of digital technologies in the regulatory field is particularly important considering that a new methodology can be used to produce evidence of regulatory value only if it has been qualified; regulatory agencies such as EMA or FDA and the pharma industries have extensive experience in the qualification of clinical, biochemical, or statistical methodologies such as those found at https://www.precisionformedicine.com, while the use of digital health technology in regulatory trials is quite recent and to a large extent best practices for the qualification of these methodologies are still being debated.
“Experts do need a safe place where to exchange best practices on the regulatory qualification of these emerging technologies; #dHealth4Trials channel is the answer,” said Dr. Wim Darte, Regulatory Affairs at Novartis Pharma AG and co-lead with Prof Marco Viceconti of the Regulatory activities in the Mobilise-D project.
Indeed, the channel will take its first steps from the recent success story of Mobilise-D and its request for qualification advice to EMA for the use of wearable sensors to quantify digital mobility outcomes and their use as biomarkers in regulatory drug trials.
“The #dHealth4Trials channel will provide to all practitioners an online community of practice where pre-competitive information can be exchanged freely” said Prof Marco Viceconti, founder of In Silico World. “We believe this is an essential step to accelerate the adoption of digital technologies in regulatory trials: this community of experts, in collaboration with experts from regulatory agencies worldwide, could develop good qualification practices for the qualification of digital health methodologies.”
In Silico World is free to join and it counts already around 200 experts with a professional or educational interest in in silico medicine and digital health. The forum is primarily intended for practitioners that develop or use in silico technologies, but it also welcomes regulators, policymakers, and patients’ representatives.