Dear visitors
We are following the current events closely and will inform you promptly should there be any changes, such as the realisation of our events.
We wish you good health and remain available online for any queries you might have.
Your Swiss Clinical Trial Organisation
Repository of publications for Clinical Trials in relation to COVID-19:
https://efgcp-events.eu/Clinical-Trials-COVID19-Repository.php
The European Commission and the Head of Medicines Agencies (EMA) support the development and approval of vaccines and treatments for COVID-19 under its recently activated plan for managing emerging health threat.
Consult EMA's special coronavirus disease (COVID-19) website for frequent updates.
Researchers are encouraged to register their pharmacoepidemiological studies related to the COVID-19 pandemic in the EU PAS Register, including a study protocol and description of the collected data. 'COVID-19' should be included in the title to allow easy retrieval by others.
The EMA's guidelines for the management of clinical trials during the COVID 19 (pdf) pandemic was updated and now also includes:
The World Health Organization (WHO) announced a large global trial, called SOLIDARITY, to test four existing treatments on their potential for drug repurposing to treat COVID-19. Read the full Science magazine article WHO launches global megatrial of the four most promising coronavirus treatments.
The spread of the new coronavirus (SARS-CoV-2) also poses a major challenge for clinical trials of medicinal products in Switzerland. Swissmedic and swissethics have therefore published a joint document, which describes the most important recommendations for the treatment of patients in clinical trials of medicinal products.
EMA’s Human Medicines Committee (CHMP) has published Points to consider on implications of Coronavirus disease (COVID-19) on methodological aspects of ongoing clinical trials, first published on 25 March 2020.
Application of the new European Medical Device Directive is planned for the end of May 20. The European Commission has now announced that it is working on a proposal to postpone the date of application by another year.
The Commission intends to submit the proposal to the Parliament at the beginning of April. A postponement would relieve pressure from national authorities, notified bodies, manufacturers, and other stakeholders and allow them to concentrate fully on the urgent priorities related to the coronavirus crisis.
Commission working on proposal to postpone MDR application date for one year, pdf
EMA’s Human Medicines Committee (CHMP) has published a statement urging the EU research community to prioritise large randomised controlled studies because they are most likely to generate the conclusive evidence needed to enable rapid development and approval of potential treatments of COVID-19.
The statement promotes a harmonised approach to data collection and a robust methodology for COVID-19 clinical trials across the EU to make best use of the available supply of investigational agents. It emphasises the need to include all EU countries in these trials
Until April 19, CEPI is seeking to identify entities that could serve as sponsors or provide clinical research organisation (CRO) support for clinical trials of COVID-19 vaccines.
More details can be found in CEPI's call for Expression of Interest, pdf.
On 24 June 2020, the SCTO is holding its annual symposium together with the Inselspital (Bern University Hospital), the University of Bern, and sitem-insel AG (Swiss Institute for Translational and Entrepreneurial Medicine).
For the tenth time, we will explore the challenges and solutions that lie ahead in clinical research in an international context.
Local and international speakers will share their perspectives on medical devices (MDs) in clinical development.
A preliminary programme is available under Symposium 2020.
Register online for the SCTO Symposium 2020
For the sixth time, the Swiss National Science Foundation (SNSF) is launching a call for clinical studies on topics that are outside the industry focus.
NEW: Applicants must submit a letter of intent (LOI) for the first time via mySNF by 26 May 2020. The platform will be open to researchers as of 1 April 2020.
Participation requirements Investigator Initiated Clinical Trials (IICT)
On 29 January 2020, the SCTO hosted its 10th Forum, held in Bern. For ten years now, we’ve been bringing together our stakeholders in clinical research in Switzerland to network, learn, debate, and ask questions in open and regular gatherings. The SCTO Forum 2020 brought them the topic of Research on Research (RoR).
What is the purpose of RoR? How is this done abroad? What is the opinion of Swiss stakeholders on RoR? Do they have concrete projects in mind that could improve clinical research? Close to 70 participants tackled these and other important questions on 29 January 2020 in Bern.
A detailed report, the programme and presentations of the SCTO Forum 2020 are available under SCTO Forum.
On 14 January 2020, three years after the CTU Network first established thematic platforms, members of all the platforms held their first joint event in Bern. The event, dedicated to the exchange and the presentation of the projects and products of the individual platforms, brought together over 70 collaborators from the CTU Network.
The morning “marketplace” enabled each of the nine platforms to showcase their activities to one another. The afternoon was dedicated to INQUIRE, a quality framework initiated by the University of Basel and University Hospital Basel, intended to optimise patient-oriented clinical research. In the workshop that followed, the participants discussed how this quality framework can be ploughed into their daily activities and projects.
A short report and photos of the day are available under SCTO Platforms.
