ECRIN provides a central resource for information about clinical trial regulatory and ethical requirements, covering over 22 European countries and multiple study types such as clinical drug trials, clinical investigations of medical devices, combination drug-device studies and nutritional studies.

ECRIN Campus can be used to locate country-specific competent authorities and ethics committees, to consult a summary of requirements for each country, and to browse related documents, such as applicable regulations and guidelines. It can be easily searched by country, study type, or a combination of both, to find relevant information.

Access the ECRIN Campus here

EUPATI Switzerland invites all interested persons to the launch event of the EUPATI platform Switzerland on 3 February 2016 in Berne. EUPATI is an informal network of patient organisations and the most important representatives of authorities, research and pharmaceutical industry.

Online registration (German/French)

The Swiss Academy of Medical Sciences (SAMS) has revised the manual «Research with human subjects». The revision particularly took into account the changes in the legal framework resulting from the new Human Research Act, which came into effect on 1 January 2014. The manual offers concrete assistance for the planning, conduct and assessment of research projects with human subjects. It provides an overview of the principles of research and the legal framework. In addition, the numerous ethical questions are discussed which arise when working with people and their personal data. The revised manual is not only addressed to researchers, but also to medical professionals from all disciplines, politicians, media representatives and other groups interested in medicine and research.

Printed copies can be requested from the SAMS by e-mail.

The Guidelines for Good Operational Practice (GGOP) of the Swiss Clinical Trial Organisation come in a new look. New design elements were added for a better overview and easier use of the electronic handbook. This comprehensive reference should serve as a quality standard for Swiss interdisciplinary academic trial centres and their clinical study projects. The quality guidelines were jointly developed by the CTU network of the SCTO and the partner network Swiss Group for Clinical Cancer Research (SAKK).

The redesigned Guidelines for Good Operational Practice (GGOP) and Factsheets of the SCTO are available here

Research projects can now be submitted to Swiss ethics committees via the online platform BASEC (Business Administration System for Ethics Committees).

More information is published on swissethics.ch

On 24 June 2013, the European Federation of Pharmaceutical Industries and Associations (EFPIA) adopted the new EFPIA Disclosure Code. On that basis, scienceindustries as the Swiss business association for the chemical, pharmaceutical and biotech industries and the responsible member association of EFPIA in Switzerland drew up the Pharma Cooperation Code (PCC), which entered into force in January 2014. The partner associations Intergenerika, Interpharma and vips have also subscribed to the PCC. In this way the European pharmaceutical industry intends in future to disclose the pecuniary benefits provided between the pharmaceutical industry and stakeholders in the healthcare sector.

It is important to note that, in general, projects performed under the Human Research Act and (co-)financed by the pharmaceutical industry are disclosed in an aggregated form by the companies. In such cases the companies do therefore not require a signed consent clause. However, hospitals and universities may have to disclose this information as per their internal transparency policies on their own webpages.

For further information see scienceindustries.ch and:

The Masterplan for the promotion of biomedical research and technology is currently being successfully implemented, the Federal Council and the Federal Office of Public Health reported on 21 October 2015. The Federal Council has taken note of a status report to this effect issued by the Federal Department of Home Affairs. The Masterplan is designed to strengthen the Swiss workplace while at the same time ensuring that the Swiss public has access to new biomedical products.

Press release
Masterplan for the promotion of biomedical research and technology

On 13 Oktober 2015 the European Commission published the Horizon 2020 Work Programme in the area of «Health, demographic change and well-being». Under Horizon 2020, the EU's research and innovation funding scheme, the European Commission will boost competitiveness by investing almost €16 billion in research and innovation in the next two years.

The Work Programme is available here

The online platform BASEC (Business Administration System for Ethics Committees) for submitting research projects to Swiss ethics committees will be activated shortly. The address of the web portal is https://submissions.swissethics.ch. Logins can already be created. The system is self-explanatory and was tested by stakeholders from academy, industry and other interest groups.

As of 2 November 2015 all new projects should be submitted through the web portal. As of 1 January 2016 the online submission is mandatory - also for old projects - replacing all former submission methods (paper, CD, other storage devices). 

More information is published on swissethics.ch.

On 6 October 2015 IMI (Innovative Medicines Initiative) launched its 6th Call for submission of project proposals under the IMI 2 programme. Deadline for submitting proposals under Call 6 is 12 January 2016.

Further information is available here

The coordination centres for clinical studies in Germany, Austria and Switzerland are organising the first joint three-nation congress for clinical trials. The two-day congress including an extensive supporting programme will be held in Freiburg/Germany in March 2016 and is aimed at all persons active in the field of clinical research.

The online registration is now open, an early booking discount is offered until December 2015.
More information about the programme and registration is available here

The European Commission has released the draft version of the Horizon 2020 Work Programme 2016-17 in the area of «Health, demographic change and well-being», focusing on personalised medicine and offering a range of opportunities for funding clinical research. The adoption and the publication of the work programme by the Commission are expected in mid-October 2015.

The draft is available here
More and up-to-date information about the draft work programmes 2016-17 is available at Euresearch

The current issue of the SAMS Bulletin focuses on the topic «Clinical research under the new HRA: improvement yes, but ...». In addition to the lead article of the Swiss Clinical Trial Organisation, the Federal Office of Public Health and swissethics share their views.

The SAMS Bulletin is available in German and French.

The new initiative «Protected Research Time for Clinicians» (PRTC) is intended to help medical researchers to dedicate 30% of their working time to their research project funded by the SNSF. Active clinicians at Swiss hospitals can apply for PRTC grants.
More information and the participation requirements are available here

The «Investigator Initiated Clinical Trials» (IICT) programme is targeted at researchers who wish to conduct an independent investigator initiated clinical trial. Support will be given to studies that are not in the industry focus and whose topics are as yet under-researched. The deadline for the submission of the letter of intent is 26 August 2015. Applications may be submitted until 15 October 2015.
More information about the participation requirements are available here

The «ECRIN-On-Board» initiative offers support to multinational, clinical research projects preparing a Horizon 2020 application for the SC1 2016 call (call deadline mid April 2016).
ECRIN can help increase the chances of success of your funding application through consulting on your application structure, evaluation of methodology, or a complete review of your project, whichever best suits your proposal.

To get more information on how to apply please contact ECRIN or your ECRIN European Correspondent for Switzerland.

On 17 June 2015 the 6th Symposium of the SCTO was held in St.Gallen, this time on the topic «Clinical / nursing / research – a convergence of two disciplines».

A detailed report and the presentations are available here

The Swiss Science and Innovation Council (SSIC) is conducting a survey on the status of biomedical research. In the report «Trends in Biomedical Research» it analyses recent developments in this scientific field, which is of major importance for Switzerland, and reflects on the potential implications of these developments for the organisation of public and private research. The SSIC formulates a series of recommendations for those authorities and institutions in charge of the promotion and regulation of biomedical research.

The report is available here

Physicians and drug developers do not always have the same research questions. The new special programme Investigator Initiated Clinical Trials (IICT) of the Swiss National Science Foundations (SNSF) will enable independent clinical researchers to answer questions that are important for patients.
The call starts on 12 August 2015. The first batch of proposals needs to be submitted by 15 October 2015.

The preannouncement and more information are available here

The working group «Biobanks» has elaborated nationwide HRA-compliant templates for the information and consent of patients regarding further use of personal data and material for research purposes as well as for the biobank regulations. The working group was composed of representatives from the industry, the Swiss Group for Clinical Cancer Research (SAKK), the Swiss Academies of Medical Sciences (SAMS), the Swiss Clinical Trial Organisation (SCTO) and the biobanks (foundation biobank-suisse).

Read more in the Swiss Medical Journal (SÄZ):

The Swiss Clinical Trial Organisation reports regularly on its activities and publishes a brief review of the year 2014.

The report ist available here

On 28 May 2015, the large Swiss hospitals and the medical faculties of the Swiss universities founded in Bern the association «University Medicine Switzerland». With this step, they reaffirm their desire for collaboration.

Together with the Kantonsspital St.Gallen the SCTO cordially invites you to join the 6th SCTO Symposium, this time on the topic «Clinical / nursing / research – a convergence of two disciplines». On 17 June 2015 leading experts and stakeholders will discuss the (not yet) exploited interdisciplinary potential of medical and nursing clinical research.

The final programme and more information about the registration is available here

On 31 March 2015, the Steering Board of the Swiss Clinical Trial Organisation (SCTO) elected at its 6th General Assembly Prof Gregor Zünd, Director Research and Teaching at UniversityHospital Zurich, as new President of the SCTO. He accepted the appointment with immediate effect.
As new Vice-President, the Steering Board elected Prof Christiane Pauli-Magnus, Co-Head of the Clinical Research Department and Head of CTU at the University Hospital Basel. In this function, she replaces with immediate effect Prof Klaus Grätz (Collège des Doyens), who is retiring from the Steering Board by the end of June 2015. The Collège des Doyens will continue to be member of the SCTO Steering Board and we will communicate the new representative in due time.

Further newly elected board members are Prof Claudio L. Bassetti, Director of the University Clinic for Neurology of the Inselspital Bern, representing the Swiss Academies of Medical Sciences (SAMS) with immediate effect, Prof Arnaud Perrier, Medical Director of the University Hospital Geneva (HUG), and Dr iur. Vital Zehnder, Head General Secretariat UniversityHospital Zurich, who assumes the function of the Quaestor.

We wish to take this opportunity to thank Prof Peter Meier-Abt (SAMS), Prof Pierre Dayer (HUG) and Dr iur. Jürg Müller (USB/Quaestor) for their appreciated engagement and we cordially welcome Prof Zünd, Prof Mauli-Magnus as well as the new members of the Steering Board. With this new composition of the Steering Board, we look forward to a continued promising and successful future.

The website www.kofam.ch has been completely revised. In addition to basic information on the regulation of human research in Switzerland, kofam.ch now offers several new tools for researchers.

On 29 April 2015, representatives of patient organisations and leading experts from industry, academia and research will give lectures on and discuss «How Patients Change Medicine». The primary target group of this event are scientific journalists and actors from the science community.

The programme is available here

Leading experts will discuss on 17 June 2015 in St.Gallen the (not yet) exploited interdisciplinary potential of medical and nursing clinical research. Besides an interface analysis of the two disciplines, ongoing interdisciplinary and multinational research projects will be presented and the current state of clinical nursing research in Switzerland discussed.

To register online, please click here.

The Federal Act on Research involving Human Beings has been into force for a year. The Swiss Clinical Trial Organisation (SCTO), umbrella organisation for clinical research in Switzerland, strongly supports the approach of the new law. Its application in practice, however, causes several, partly serious, problems. The SCTO has listed the most significant ones in a position paper formulating possible solutions.

If you have any questions, please contact Annette Magnin, Managing Director SCTO, or Prof Pierre Dayer, President SCTO.

The position paper is available in German and French:

Over 90 participants attended the fifth forum of the SCTO on 28 January 2015 on the topic «General Consent» in Bern. A summary report will follow shortly.

The presentations of the forum 2015 are available here

Since December 2014 the SCTO has its first associated member: As a not-for-profit institution involved in clinical research the Swiss Paraplegic Centre (SPC) Nottwil has met all conditions of admission. The requirements for associated membership as well as the rights and duties of an associated member are defined in the SCTO membership bylaws.
The SCTO is pleased with this extension and cordially welcomes the SPC.

More information about the CTU SPC Nottwil is available here

 

 

For older news and press releases please see our news archives 2014 and 2013.