On 27 September 2020, the Swiss electorate will vote on the popular initiative called “For Moderate Immigration” (Limitation Initiative). This initiative calls for ending the free movement of people between Switzerland and the European Union, which is guaranteed by the Agreement on the Free Movement of Persons (AFMP).

Passing the Limitation Initiative would have grave consequences for clinical research in Switzerland. For these reasons, the Swiss Clinical Trial Organisation (SCTO) joins the Swiss Science Council, the Swiss National Science Foundation and the Swiss Academies of Arts and Sciences in their opposition to the Limitation Initiative and cautions that, if passed, this initiative would negatively impact Switzerland as a place to conduct research.

The statement of 25 August 2020 is available as PDF under Publications: Statements.

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Since 2015, Switzerland has been an Observer country of ECRIN, the European Clinical Research Infrastructure Network. In July, the extension of Switzerland’s observership was granted by an unanimous vote of the ECRIN members.

This gives clinical researchers in Switzerland continued access to services and consulting that facilitate, among other things, the conduct of multinational, academic clinical trials. Moreover, sharing best practices and resources among national scientific ECRIN partners are major added values for the academic research community, saving potential costs.

Find out more about ECRIN members and observers in the ECRIN Annual Report 2019 and the SCTO’s role under Network.

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The EU Clinical Trial Regulation requires the preparation of a summary of trial results in lay language. EU Commission recommendations exist on the content of lay summaries, but how to develop a standard for their collaborative planning, preparation and dissemination?

Under the leadership of the European Forum for Good Clinical Practice (EFGCP) and the European Federation of Pharmaceutical Industries and Associations (EFPIA), representatives from over 60 international patient organisations, pharmaceutical companies, academic institutions, not-for-profit organisations, and CROs prepared the Good Lay Summary Practice recommendations document and launched a public consultation.

The public consultation is open until 14 September 2020 on the EFGCP’s website at Recommendations: Good Lay Summary Practice.

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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.

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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?"

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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

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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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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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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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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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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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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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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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