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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.

Archive 2013

17 December 2013

New legislation on research involving humans comes into force

New legislation on research involving humans comes into force on 1 January 2014. Besides the Human Research Act (HRA), the legislation includes three ordinances:
• Ordinance on Clinical Trials in Human Research
• Ordinance on Human Research with the Exception of Clinical Trials
• Ordinance on Organisational Aspects of the Human Research Act

The HRA regulates research involving humans (in particular clinical trials), research on human cadavers, embryos and foetuses, and research involving biological material and health-related personal data. All of these research projects must be authorised by an ethics committee. Clinical trials also need to be registered. The overall aim of the new act is to simplify certain processes: it standardises authorisation and registration procedures and reduces the administrative burden for research projects involving low risk for the participants.
The new legislation aims to protect the dignity, privacy and health of human subjects of research. The law also aims to create appropriate conditions for research involving humans, help to improve the quality of this research and foster greater transparency in this area.
Further information on the law and the main changes it involves can be found on the website of the Coordination office for research involving humans (kofam).

Federal Council plans to boost biomedical research and technology
The Federal Council intends to create an optimum environment for biomedical research and technology and continue to support this field. In a comprehensive masterplan it sets out which strategies are to be pursued, which measures have already been taken and those being planned (The Federal Council).

12 December 2013

Horizon 2020 – first calls published

The first calls of the Horizon 2020 with the adopted work programme are published (Horizon 2020).

ECRIN (the European Clinical Research Infrastructures Network) may contribute to an H2020 clinical trial application through:
• Information during the preparation of the project
• Consulting on protocol development and application strategy
• Acting as partner in the Consortium (e.g. work package on protocol development; international clinical trial management through its network partners)

Contact your ECRIN EU Correspondent (Switzerland) or read more here

25 November 2013

The next EU framework programme for research and innovation - Horizon 2020

Horizon 2020 is the financial instrument of the European Commission that runs from 2014 to 2020 with a €80 billion budget. The EU’s new programme for research and innovation is part of the drive to create new growth and jobs in Europe. The proposed structure consists of three basic priorities: Excellent Science, Competitive Industries and Societal Changes. Publication of the first calls with the adopted work programme is expected on December 11, 2013 (Horizon 2020).

Several programmes offer funding suitable for Medicine & Pharmaceutics Research, more information and updates are available from Euresearch (Euresearch).

A national event to launch Horizon 2020 is being organised by the State Secretariat for Education, Research and Innovation (SBFI) and Euresearch and will take place on January 14-17, 2014 at the Stade de Suisse in Bern: Programme and Registration

23 September 2013

New ordinances on the law on research involving humans

By its resolution of 20 September 2013, the Federal Council has approved the ordinances on the law on research involving humans. The ordinances consist of:
  • Ordinance on clinical trials on research involving humans (Verordnung über klinische Versuche, KlinV)
  • Ordinance on projects on research involving humans not considered as clinical trials (Humanforschungsverordnung, HFV)
  • Organisation ordinance on the law on research involving humans (Organisationsverordnung HFG, OV-HFG)
The statements received during the consultation procedure were analysed and summarised in a report, which was published together with the Federal Council Decree.
The law on research involving humans and the ordinances enter into force on 1 January 2014. There is no transition period foreseen. The implementation responsibility lies with the Cantonal Ethics Committees and Swissmedic as well as the relevant federal enforcement authorities (Federal Office of Public Health, Swiss Federal Office for the Environment).

For further information see (only in German and French available) >>

4 September 2013

Risk-adapted monitoring in clinical trials

In August 2013, the U.S. Department of Health and Human Services Food and Drug Administration (FDA) published a guidance “Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring”. Although the document is primarily oriented towards clinical studies with regulatory purposes, the principles are applicable to all types of studies.

In order to achieve a more efficient and more intelligent use of available resources, risk-based monitoring strategies should be implemented. A possible consequence of the risk-based approach is increased centralised “remote monitoring” that focuses on critical data elements and processes necessary to achieve study objectives. The number of routine visits to all sites could be reduced and thus costs saved. At the same time, the safety of the participating subjects or the quality of data would not decrease, but, on the contrary, rather improve.
With its “Reflection paper on risk based quality management in clinical trials”, the European Medicines Agency (EMA) too follows a respective monitoring approach, however, more broadly aiming at all quality management processes within the planning and conducting of a clinical study.

18 July 2013

Public consultation open: EMA draft policy on the “publication and access to clinical trial data”

The European Medicines Agency (EMA) has released a draft policy on the publication and access to clinical trial data for a three-month public consultation (EMA press release). Stakeholders have until 30 September 2013 to send their comments on the draft policy to the Agency.
The draft policy balances the commitment to give the widest possible access to data for independent scrutiny with the need to protect personal data as well as legitimate commercially confidential information.
The EMA expects to publish the final policy at the end of 2013 and this should come into force on 1 January 2014.

Download the EMA policy: 

21 June 2013

Successful Symposium “Good Governance in (Clinical) Research with Human Data and Tissue”

The fourth symposium of the SCTO was held on 20 June 2013 in Geneva, jointly organised with the Geneva University Hospitals (HUG). Leading national and international experts and stakeholders gave an insight into the latest developments on the subject of “Good Governance in (Clinical) Research with Human Data and Tissue”, a currently extremely dynamic research area.

A detailed report on the event is available here >>

24 May 2013

Data Management quality guidelines for Swiss academic trial centres

Within the framework of the harmonisation concept for the improvement of the clinical trial culture in Switzerland, the SCTO has published the Guidelines for Good Operational Practice (GGOP). These quality guidelines for Swiss interdisciplinary academic trial centres – a binding quality-standard for clinical studies for members of the network – were now supplemented by Data Management Quality Guidelines, elaborated in close collaboration with the Clinical Trial Units and the Swiss Group for Clinical Cancer Research (SAKK). These guidelines are based on European standards, as defined by ECRIN (European Clinical Research Infrastructures Network).
By releasing the quality guidelines, the SCTO significantly contributes to a continuous quality improvement of academic clinical research and its recognition on a national and international level.

Download the PDF:

5 April 2013

Invitation: Symposium 2013 on “Good Governance in (Clinical) Research with Human Data and Tissue”

Leading national and international experts and stakeholders will discuss the current topic “Good Governance in (Clinical) Research with Human Data and Tissue” in Geneva on 20 June 2013. They will present latest trends in this field from a variety of perspectives while illustrating related social and economic effects and ethical questions.

Further information and registration >>

2 April 2013

SwissPedNet: Research collaboration dedicated to children

It is internationally recognised that treatments for children are problematic as the medication used has usually been developed and tested only for adults. Paediatric research is at a disadvantage compared to research in adult medicine due to many reasons. Starting with very low patient numbers and ending with particular ethical and psychological concerns, which all hamper planning and conducting clinical trials in children. To improve this situation, the SwissPedNet has been founded.

You find the press release about the SwissPedNet here:

22 February 2013

First announcement Symposium 2013: 
Good Governance in (Clinical) Research with Human Data and Tissue

Leading national and international experts and stakeholders will discuss the current topic “Good Governance in (Clinical) Research with Human Data and Tissue” in Geneva on 20 June 2013. They will present latest trends in this field from a variety of perspectives while illustrating related social and economic effects and ethical questions.

The preliminary programme is available here >>

31 January 2013

Forum Clinical Research 2013

On 30 January 2013, the second Forum “Clinical Research” of the Swiss Clinical Trial Organisation (SCTO) took place in Bern. During the first part of the event, exponents of academic research, pharmaceutical industry as well as exponents of authorities shared their views on “Transparency and Quality in Clinical Research – Positions and Prospect”. In the second part of the forum, the institutions involved in clinical research reported on their activities in the past year and introduced those for the coming year.

A short summary as well as the complete collection of presentations of the Forum 2013 are available here >>