Guidance on the management of clinical trials during the COVID-19 (coronavirus) pandemic

We would like to bring to your attention the publication of the “guidance on the management of clinical trials during the COVID-19 (coronavirus) pandemic”.

The European Medicines Agency, Good Clinical Practice (GCP) Inspectors Working Group, the Clinical Trials Facilitation and Coordination Group (CTFG, a working group of the Heads of Medicines Agency (HMA)), the Clinical Trials Expert Group (CTEG, a working group of the European Commission representing Ethics Committees and National Competent Authorities) and the European Commission (EC) acknowledge the impact of COVID-19 on the health system and broader society, and the impact it may have on clinical trials and trial participants. Extraordinary measures may need to be implemented and trials adjusted due to e.g. trial participants being in self-isolation/quarantine, limited access to public places (including hospitals) due to the risk of spreading infections, and health care professionals being committed to critical tasks. Therefore, EMA, EC and HMA strongly support the efforts of the GCP Inspectors’ Working Group for developing a harmonised EU/EEA-level guidance to mitigate the negative effects of the COVID-19 pandemic on the conduct of clinical trials.

The situation is evolving, and pragmatic actions may be required to deal with the challenges of conducting research, and in ensuring the rights, safety and wellbeing of participants. The points mentioned below are intended to provide guidance for all parties involved in clinical trials during this time.

Due to the urgency, this guidance is issued without prior public consultation. The sponsors should note that due to the rapidly evolving situation further updates to this guidance are possible and likely.

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COVID-19: EJEM articles published ahead of print!

Sharing information on Covid-19 is extremely important right now. That's why we would like to share these articles from the Published Ahead of Print page of the European Journal of Emergency Medicine, https://journals.lww.com/euro-emergencymed/Citation/publishahead/ 

COVID-19: emergency medicine perspectives from Hong Kong
Hung, Kevin K.C.; Walline, Joseph H.; Graham, Colin A.

COVID-19: response plan for International Medical Assistance companies

François-Xavier Duchateau, Geoffrey Ramin and Anne Lepetit

COVID-19: one threat, one world, one response (magical thinking)
Òscar Miró 

How emergency departments prepare for virus disease outbreaks like COVID-19
Martin Möckel, Ulrike Bachmann, Wilhelm Behringer,Frieder Pfäfflin and Miriam Songa Stegemann

COVID-19, a UK perspective
Joanna Sriskandar and Benjamin Bloom

 

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Abstract submission period prolonged

NEW DATE: 30 April 2020 - Midnight (CEST) +02:00 UTC 

While we are all facing an exceptional situation due to the impact of COVID-19 in Europe and worldwide, we are all aware that your time is precious at the moment and highly dedicated to your hospital. EUSEM consequently decided to prolong the abstract submission period to 30 April 2020. 

We all hope the situation will get better very soon and we will all see you in Copenhagen in September!

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Lessons learned from Italy

COVID-19 is one of the greatest challenges that the entire World is called to face since the dark years of the Second World War.

In this time of uncertainty and fear, it is necessary to maintain clarity and reiterate the principle of science, knowledge and, above all, expertise.

In this regard, there is an ongoing commitment by SIMEU, the Italian scientific society made up of the doctors and nurses in the Emergency Medicine departments operating in the approximately 650 Emergency Rooms throughout Italy.

As widely known, Italy has been the first European Country called to cope with the extreme COVID-19 emergency which has overturned all the usual procedural practices. SIMEU immediately acted to promote the circulation of knowledge by sharing working documents based on various field experiences, and published them on THIS WEBSITE to benefit its members.

SIMEU also deems it useful to disclose these documents to the international audience.

Documenting the real healthcare emergency flows as well as the adopted solutions and bringing them to the attention of the collegues around the World is the most effective assistance SIMEU can provide to help them in developing a more efficient organizational model suited for the new needs.

Taking an optimistic look at the situation, one side effect of the sacrifice and the efforts of those who "got there first" is that they are able to provide concrete help to those who come later making them better prepared.

We wish to convey this optimistic know-how to all our colleagues who may take advantage of it. We all can get through this, together!

 

Dr Salvatore Manca _ President

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COVID webinar recording available

Dear friends,

March 28 we had the COVID-19 webinar with speakers from 9 different European countries, sharing their experience and explaining about the Covid-19 management in their countries.

Please find the recording on the EUSEM Academy. This recording is accessible for all.

Please note that with your EUSEM account you can access much more educational material. EUSEM members can access everything, Congress participants can access the webcasts from the respective year. If you are not a member or participant you can still access a lot of links to educational material covering the EM curriculum topics. In short, the Academy is an educational treasure!

https://academy.eusem.org/eusem/2020/covid-19/290502/session.speakers.covid-19.webinar.a.unique.insight.in.highly.impacted.countries.html

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Webinar on COVID-19: Saturday 28 March 9:00 CET

In the actual Covid-19 crisis, sharing information is of extreme importance to learn and improve for now and the future. EUSEM wants to stimulate this by using its network and facilitate the transference of experiences between participating members from all over Europe, providing a unique insight of the real situation in the EDs with up to date experiences and difficulties faced during the different periods of the epidemic.

A 90 minute webinar is going to take place this Saturday, 28th March at 9:00 AM CET. 

We will have speakers from Italy, Spain, Turkey, Belgium, France, Germany, Greece, Norway, UK and The Netherlands. Each representative will give an insight of the situation in their country, addressing the actual situation, methods of triage, approach and lessons learned.

Watch the live stream on Facebook and have a clear perspective of the Covid-19 management in different settings across Europe focused on the emergency health systems.

When: Mar 28, 2020 09:00 AM CET

Topic: COVID-19: a unique insight in high impacted European countries

Live stream on Facebook: https://www.facebook.com/officialEUSEM/

 

 

 

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