Two more patients have been randomised to the EURO SHOCK trial, one each in Spain and Germany! Many thanks to the local teams for their continuous efforts.
We are also happy that all of our clinical sites that were active pre-COVID-19 are now screening again. This is after they have received green light from their local authorities as well as the study sponsor.
The first EURO SHOCK patient in Norway was randomised by Truls Myrmel and his team at the University Hospital North Norway. This event also marks another important milestone, as this also is the first patient randomised after the suspension of the study due to the COVID-19 pandemic.
Our partners in Spain, Germany, Latvia and Norway have re-started their recruitment of patiens after receiving clearance from their local regulators and the study sponsors. This comes after the numbers of COVID-19 cases have considerably lowered in those areas.
Due to the Covid-19 pandemic, EURO SHOCK is suspending trial recruitment. Our thoughts go to our colleagues and their patients fighting the virus. We are using this time to come back stronger and deliver this important trial.
King's College London randomised the first patient in the UK. Congratulations to Sameer Patel and his whole team!
Manel Sabate and his team in Spain Hospital Clinic de Barcelona randomised EURO SHOCK first patient. Congratulations to the team.
The Katholieke Universiteit Leuven hosted member of EURO SHOCK for a one day meeting at the beginning of December. The successful meeting was an opportunity to discuss the project advancements, the trial and plan 2020.
Prof. Truls Myrmel and his team from the University Hospital of North-Norway have received the green light to start recruiting their first patients. This important step for the EURO SHOCK clinical trial on CGS comes after months of intense work. Other institutions will start recruiting in the coming weeks.
The process to approve a recruiting site is led by the clinical trial sponsor, who takes responsibility to initiate, and manage or finance the clinical trial, but does not conduct it. This role in EURO SHOCK is performed by the University of Leicester.
The EURO SHOCK consortium put months of intense work into the preparation of the trial. Common documentation, including consent forms and patient information material, are jointly developed by EURO SHOCK’s ten clinical centres and the sponsor. Each site also has to undergo their country-specific ethical process, which required the translation of the documentation into local languages. The last step in preparation for the trial is the Site Initiation Visit (SIV) to monitor and ensure the site is ready to recruit patients.
Clinical trials: Sponsors and sponsor-investigators. Retrieved on 24.09.2019 from https://learn.marsdd.com/article/clinical-trials-sponsors-and-sponsor-investigators/
Site Initiation Visit (SIV). Retrieved on 24.09.2019 from https://www.nbt.nhs.uk/research-innovation/running-your-study/site-initiation-visit-siv
The EURO SHOCK trial includes the main cardiovascular hospitals in nine European countries. UPC is participating in the project with CardioSense, a device that provides an early cardiovascular diagnosis in less than 60 seconds.
Please read the news here
On 12th December 2018 investigators gathered at the Royal Society of Medicine in London for the last preparations before the trial begins. The recruitment target is to randomise more than 400 patients in 34 months starting from 1st February 2019.