News about the ongoing coronavirus pandemic
National authorities are now closely following trials and research into Covid-19, both within Norway and internationally. With regards to trials being carried out in Norway, there is a need to coordinate research across the regional health authorities and health trusts to ensure good cooperation and coordination between the trial locations. This will make it possible to include patients from multiple health authority regions, and also from smaller health trusts when appropriate. Please see the information box “National overview of Covid-19 trials” below.
The Norwegian Intensive Care and Pandemic Register (NIPaR) is part of the national network of medical quality registers. In connection with the Covid-19 pandemic, in 2020 the register was expanded to also include patients admitted to the specialist health service with infectious diseases during epidemics (that include Norway) or pandemics. Please see the information box “Norwegian Intensive Care and Pandemic Register” below.
Standardised biobank protocols have been developed that are relevant to ongoing and planned Covid-19 clinical trials, including the WHO Solidarity trial. It is desirable that the protocols be shared nationally to facilitate an optimally standardised collection of biobank samples in connection with Covid-19. Please see the information box “Important links”.
Available research on Covid-19 is increasing rapidly. The Norwegian Institute of Public Health has prepared a live map of Covid-19 research that provides a continuous overview of various types of scientific publications.
REK (the Regional Committees for Medical and Health Research Ethics) and SLV (the Norwegian Medicines Agency)
Before a clinical trial can be initiated, it must be processed and approved by REK (the Regional Committees for Medical and Health Research Ethics). In addition, all clinical trials must be processed and approved by SLV (the Norwegian Medicines Agency). To ensure proper, effective cooperation, REK and SLV have adapted their application processing for trials focusing on Covid-19. Applications are processed on an ongoing basis, independently of the set deadlines. REK is working on the basis of a case-processing time of three days.
SLV requires a risk assessment to be carried out of all affected clinical trials during the coronavirus pandemic, and the risk assessment to be documented. Mal for risikovurdering (the risk assessment template) is a tool intended to make this job easier. If the monitoring is affected by the coronavirus pandemic, this should be described in the monitoring plan. A separate proposal has been prepared (see section 1.1 of the Monitoreringsplan (Monitoring plan)).
In connection with Covid-19, the European (EMA) and US (FDA) medicines agencies have issued recommendations to sponsors regarding how to deal with clinical trials and trial participants. The EMA is working on a standard protocol to facilitate data-sharing between overlapping trials that are currently being planned.
LMI (the Norwegian Association of Pharmaceutical Manufacturers)
The LMI has published information from the university hospitals on how pharmaceuticals companies and other external partners should deal with clinical trials at Norwegian hospitals.
NorCRIN will closely follow developments and continue to keep our partners and users up to date.