19 May 2020
Chairs: Marc Mes (Health Canada), Peter Arlett (European Medicines Agency)
Guido Rasi thanked everyone for their time and dedication to the protection of public health, especially during the pandemic. RWE can play an important role in the evaluation of the disease epidemiology and in the monitoring of medicinal products used in Covid-19 infected patients. This meeting is an essential step to explore ways and agree on how to collaborate on topics such as pregnancy research, building international cohorts and prepare for vaccines monitoring. Guido also encouraged the international partners to publish on their website as much information as possible on their Covid-19 related activities, including on observational studies to increase transparency and foster collaboration.
Marc Mes welcomed participants to the meeting. He shared the main objective of the meeting which was to discuss specific proposals on observational studies that addressed knowledge gaps and which would benefit from collaboration with regulatory partners through ICMRA.
Peter Arlett briefly summarised the meeting where colleagues shared their plans or ongoing activities. The outcome was to encourage the sharing of information including methods on observational studies to increase collaboration and have a positive impact on responding to this pandemic.
Gaya Jayaraman (Health Canada) presented on work underway through the drug safety and effectiveness research network in Canada, with reference to the CNODES distributed network of research sites. They have established a core data model across 6 provinces in Canada, that allows the data to be meta-analysed to produce pooled results. They can easily add new sites over time. The cohort can facilitate the identification of knowledge gaps and respond to priorities related to use/safety/effectiveness of medicines and Covid-19 disease.
Xavier Kurz informed about the EMA’s plan to launch a procurement call to establish a multicentres’ cohort and expressed interest in further collaboration, including on the drafting of research questions.
The FDA is also supportive of further collaboration on the topic.
Xavier Kurz presented the EMA’s project for vaccines effectiveness and safety monitoring to be in place by December 2020 when vaccines start to be introduced on the market.
The idea is to have a system ready to:
FDA, MHRA and Health Canada expressed their interest to further collaborate.
Finally, a representative of WHO indicated that the GACVS (WHO) will further discuss vaccines monitoring next week, and that he will share the outcome of the discussion with ICMRA.
Peter Arlett proposed to have another ICMRA general TC on Covid-19 and to establish technical working groups on the three topics for collaboration (pregnancy research, building international cohorts and preparing for vaccine monitoring).
The Co-Chairs, through the ICMRA Secretariat, will issue a call for additional members interested in participating in the technical working groups for the three proposed collaborative projects on pregnancy research, building international cohorts and preparing for vaccine monitoring.