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The SCTO is an independent organisation and is based on a joint initiative of the Swiss National Science Foundation and the Swiss Academy of Medical Sciences.

As of 2017, the SCTO is a research infrastructure of national importance funded by the State Secretariat of Education, Research and Innovation and the Swiss National Science Foundation.

News

News

3 July 2020

Federal Council adopts revision of the Ordinance on Medical Devices and the new Ordinance on Clinical Trials for Medical Devices

At its meeting on 1 July 2020, the Federal Council adopted the revision of the Ordinance on Medical Devices (MepV) and the new Ordinance on Clinical Trials for Medical Devices (KlinV-Mep). 

Due to the coronavirus pandemic, the European Commission has postponed the entry into force of the new European Medical Device Regulation. For reasons of coherence, the entry into force of the new provisions in Switzerland will be carried out gradually. Only the deviating regulations will come into force on 1 August 2020.

Read more about the topic (in German or French) at www.bag.admin.ch.


Covid-19 (CH)

12 June 2020

The CORON-ACT study – an example of a Swiss multicentre trial to combat COVID-19

The CORON-ACT study is a Swiss multicentre randomised controlled trial (RCT) aimed at combatting COVID-19. Coordinated by the CTU Bern, the CORON-ACT study is currently being conducted in Lausanne, Lugano and Zurich.
 

"It was very important to have the CTU."

In an online interview with the SCTO, Prof. Peter Villiger, Chairman and Head of the Department of Rheumatology, Immunology and Allergology at the University Hospital (Inselspital) Bern and principle investigator of the study, explains the aim of the trial, shares his experience with the regulatory process, discusses the collaboration with the CTU Bern, and outlines the main issues the study has faced so far.


Executive Office

3 June 2020

Increased patient involvement and lasting networks in clinical research

The SCTO is part of a dynamic environment. Profound changes are reshaping clinical research not only in Switzerland but around the globe, and these changes are creating new trends and opening up new opportunities. In response to these changes, the SCTO has set the following two strategic priorities for the upcoming 2021–2024 performance period:

  • active patient involvement in clinical research and
  • increased and longer-lasting collaboration between all parties involved in clinical research.

We are delighted to pursue these new priorities with Cordula Landgraf. She is a proven expert in these areas and joined our team at the beginning of June. Welcome to the SCTO!
 

“Enabling truly meaningful cooperation with patients” 

You can learn more about Cordula Landgraf’s background, what she is looking forward to at the SCTO, and what she considers “good networking” in our video interview with her.


COVID-19 (CH)

19 May 2020

Snapshot of Swiss research on COVID-19

Researchers in Switzerland are working hard to improve the clinical and public health response to the COVID-19 pandemic. The Swiss National Science Foundation’s (SNSF) COVID-19 project database provides the public with a snapshot of these efforts.

Covid-19 project database
 

The SNSF funds 36 new coronavirus research projects

As the coronavirus pandemic began to take hold, the SNSF took swift action by launching a special call on coronaviruses on 6 March 2020. The call was enthusiastically received in the research community. Under this special call on coronaviruses, the societal and biomedical aspects of epidemics will be investigated with a total budget of 10 million francs. The projects will start as of 1 June 2020.

SNSF website: Special call on coronaviruses

Research related to COVID-19

All Clinical Trial Units (CTUs) of our member institutions are currently working at full speed to support research activities related to the COVID-19 outbreak.

A summary of current activities of the individual CTUs can be found under COVID-19.


Overview of submitted clinical trials and research projects

A list of submitted but not yet approved clinical trials and research projects on COVID-19 in Switzerland is available at swissethics.ch.


COVID-19 (EU)

COVID-19: Latest updates on the COVID-19 pandemic from the European Medicines Agency (EMA)

The latest updates on the COVID-19 pandemic from the European Medicines Agency (EMA), including all news and press releases, are available at www.ema.europa.eu.


COVID-19 (EU)

19 May 2020

International coordination needed to encourage conduct of large, decision-relevant COVID-19 clinical trials

Although the scientific community has responded to the COVID-19 challenge in an unprecedented manner, there are concerns about the growing number of COVID-19 stand-alone clinical trials with a small number of participants and observational studies, which might not generate the data required for regulatory decision-making.

In an article published on 15 May 2020 in Clinical Pharmacology & Therapeutics, EMA authors have therefore set out concrete actions that stakeholders involved with COVID-19 clinical trials should take to generate the type of conclusive evidence needed to enable rapid development and approval of potential treatments and vaccines against COVID-19.

EMA press release

Article "Clinical trials for Covid‐19: can we better use the short window of opportunity?"


COVID-19 (EU)

5 May 2020

How EMA fast-tracks development support and approval of medicines and vaccines

As researchers race to develop vaccines and therapeutics against COVID-19, EMA has published an overview of how the Agency will accelerate its regulatory procedures so that marketing authorisations of safe, effective and high-quality COVID-19 related medicines can be granted as soon as possible.

The rapid procedures described in EMA's inventory include:

  • Rapid scientific advice, through which developers can receive prompt guidance and direction on the best methods and study designs to generate robust data on how well a medicine or vaccine works, how safe it is, as well as on the manufacturing and control process to establish its quality. In the context of COVID-19, fees for scientific advice are waived and the procedure is reduced to a maximum of 20 days, compared to normally 40-70 days.
  • Rapid agreement of paediatric investigation plans (PIPs) and rapid compliance check: The total review time for a PIP for COVID-19 products will be reduced to 20 days, compared to normally up to 120 days active review time. In case needed, EMA also carries out a check to ensure companies comply with the agreed measures listed in each PIP before a marketing authorisation can be submitted, which will now also be reduced to 4 days.

Read more in EMA's press release published on 4 May 2020


COVID-19 (EU)

30 April 2020

ECRIN launches Clinical Research Metadata Repository

The COVID-19 crisis requires researchers to join forces worldwide to find a cure and a vaccine. Sharing research data is a critical step in this global cooperation effort. In this context, the European Clinical Research Infrastructure Network (ECRIN) launched the Clinical Research Metadata Repository, which includes COVID-19 data. 

The Clinical Research Metadata Repository allows the discovery of clinical studies and related data objects, for example protocols, information sheets and consent forms, data management plans, statistical analysis plans, case report forms, results, publications, and descriptive metadata. It is freely available for all scientific researchers working in clinical research, and especially for those working on COVID-19.

The system is updated regularly by collecting data from the most important sources of information worldwide, from New Zealand to the Netherlands and from Japan to Lebanon. The current Clinical Research Metadata Repository is the first beta release of the platform; ECRIN updates the content of the platform regularly, and continues working on newer releases.

Visit https://www.ecrin.org/clinical-research-metadata-repository

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Furthermore, ECRIN established a COVID-19 Taskforce to manage and deploy tools and services to help the scientific research on COVID-19. 

Visit https://www.ecrin.org/covid-19-taskforce


COVID-19 (CH)

17 April 2020

Updated recommendations Swissmedic/swissethics for the treatment of patients in clinical trials of medicinal products

The updated joint doucument by Swissmedic and swissethics describing the most important recommendations for the treatment of patients in clinical trials of medicinal products is available under:

Joint Guidance of Swissmedic and swissethics on the management of clinical trials with medicinal drug products in Switzerland during the COVID-19 pandemic (Version 2.1, 07.04.2020)


News

16 April 2020

European Commission postpones application of the Medical Devices Regulation to prioritise the fight against coronavirus

In early April, the European Commission adopted a proposal to postpone by one year the date of application of the Medical Devices Regulation to allow Member States, health institutions and economic operators to prioritise the fight against the coronavirus pandemic.

Commission postpones Medical Devices Regulation


Covid-19 (EU)

31 March 2020

EFGCP-AWP Covid-19 Repository

Very comprehensive repository of recommendations and guidances from regulatory authorities and others concerning clinical trials in relation to COVID-19:

https://efgcp-events.eu/Clinical-Trials-COVID19-Repository.php


COVID-19 (EU)

27 March 2020

Updates from the EMA

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.
 

EU PAS Register for 'COVID-19' studies

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.
 

Version 2 available of Guidelines for the management of clinical trials during COVID-19

The EMA's guidelines for the management of clinical trials during the COVID 19 (pdf) pandemic was updated and now also includes:

  • safety reporting
  • distribution of in-vitro diagnostics
  • medical devices
  • auditing
  • informed consent
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COVID-19 (Int.)

27 March 2020

Science magazine overview on the most promising coronavirus treatments being tested in mega trials

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.


COVID-19 (CH)

26 March 2020

Recommendations for the treatment of patients in clinical trials of medicinal products

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.

Joint Guidance of Swissmedic and swissethics on the management of clinical trials with medicinal drug products in Switzerland during the COVID-19 pandemic


COVID-19 (EU)

25 March 2020

Points to consider on implications of Coronavirus disease (COVID-19) on methodological aspects of ongoing clinical trials

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.


COVID-19 (EU)

25 March 2020

Postponement of the MDR application intended to allow focus on urgent COVID-19 priorities

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

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COVID-19 (EU)

19 March 2020

Call to pool research resources into large multi-centre, multi-arm clinical trials to generate sound evidence on COVID-19 treatments

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

EMA press release

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Call for Expression of Interest for Sponsors and CRO

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.


Events

6 March 2020

Medical devices: lost in translation?

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

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Research promotion

27 February 2020

Investigator Initiated Clinical Trials (IICT) 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)


Events

31 January 2020

SCTO Forum 2020: Research on research

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.

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Network

28 January 2020

SCTO Platforms: Yielding a bumper harvest

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.

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SCTO Platforms Event 2020

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