The SCTO’s Managing Director Victoria Sarraf was given the opportunity to provide insights on the problem of flawed clinical trials in Switzerland for an article in the Swiss medical bulletin Schweizerische Ärztezeitung.

Clinical trials require such a wide range of competencies that one person can hardly provide them all. The SCTO and its Clinical Trial Unit (CTU) Network facilitate high-quality clinical research, support researchers by providing professional services, and make tools and resources available free of charge. By doing this, the SCTO ensures that the expertise within our network can benefit as many projects as possible.

In our quality policy, we describe how the SCTO defines quality and how it promotes quality in individual studies.

Wie verlässlich sind Studien? (How reliable are studies?) by Simon Koechlin, published on 30 August 2023 in Schweizerische Ärztezeitung (in French and German)

Quality Policy of the SCTO’s CTU Network

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The European Clinical Research Infrastructure Network (ECRIN) and the Swiss Clinical Trial Organisation (SCTO) are very pleased to announce that Switzerland officially became an ECRIN European Research Infrastructure Consortium (ERIC) Member country on 22 May 2023.

Since Switzerland joined ECRIN as an Observer country in 2015, it has taken part in numerous ECRIN activities, counting more than twenty multinational clinical trials or infrastructure projects, including platform trials on COVID-19. With the transition of Switzerland to ECRIN Member, ECRIN’s network now counts 12 Member countries and 1 Observer country. The total reach of the ECRIN network covers over 361 million European citizens, with an average of 6.5 countries per trial.

The SCTO represents, in the ECRIN Network Committee, a research infrastructure comprising a large coordinated CTU Network across Switzerland and hosts the European Correspondent, which is the national contact point for ECRIN.

Read the full press release here
ECRIN website

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This year’s SCTO Symposium is dedicated to the topic of clinical research in the age of digital health and will take place in St Gallen on Wednesday, 7 June.

Digital health is one of the fastest growing segments in the healthcare sector, and it opens up exciting new possibilities for clinical research. Health apps, electronic patient records, and surgical robots are already part of our lives, yet these new technological opportunities also come with challenges and potential risks.
 
At our symposium, we will look at real-life examples of digital health applications in clinical research projects and will discuss legal and ethical aspects that have to be taken into consideration.
 
The event is being organised by the Swiss Clinical Trial Organisation (SCTO) and the Clinical Trial Unit (CTU) St.Gallen. It will take place in English.

Programme and registration: SCTO Symposium

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Since 2014, the Human Research Act (HRA) and its corresponding ordinances have been protecting individuals who participate in medical research projects; this legislation also ensures that research on humans has the necessary quality and transparency. After carrying out an evaluation, the Federal Council decided to revise the HRA’s ordinances in order to ensure that research conditions are up to date.

On 26 April 2023, a consultation procedure was opened for the proposed amendments to the ordinances. During the consultation phase, which runs until 16 August 2023, the SCTO and its members will review the proposed amendments together and present their comments on the changes.

• Federal Council’s press release from 26 April 2023 (in French, German, and Italian)
• Documents related to the consultation procedure for amendments to the HRA’s ordinances (in French, German, and Italian)

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We have created a new Excel template to help researchers plan and track public and patient involvement (PPI) activities in an initiative or a research project. The template also helps researchers evaluate whether those PPI activities had the desired effect.
 
In order to evaluate PPI activities and processes, it is important to gather feedback from PPI contributors. Therefore, the Excel template includes a worksheet with a feedback form (in English, French, German, and Italian). Contributors’ feedback allows researchers to improve how they collaborate with PPI partners.
 
Planning, Tracking, and Evaluating PPI Activities Template

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With the Young Talents in Clinical Research program, the Gottfried and Julia Bangerter-Rhyner Foundation and the SAMS encourage young medical doctors to start out in clinical research. For 2023, CHF 1 million is made available to finance protected research time and project grants for a consecutive research project. The submission deadline is 30 June 2023.

You can find the call on the website of the SAMS.

For additional funding opportunities for young clinical researchers, visit the Clinical Research Careers website.

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Delegated experts from the SCTO’s Clinical Trial Unit (CTU) Network conducted a meta-analysis of individual patient data from 10’480 patients in order to assess the effectiveness of remdesivir in treating COVID-19. The findings provide invaluable insights into the previously conflicting evidence of the drug’s effectiveness in certain patient populations. The research was conducted as part of the SCTO’s participation in the EU RESPONSE consortium and was recently published in The Lancet Respiratory Medicine. Congratulations to the lead authors, Dr Alain Amstutz and Dr Benjamin Speich, from the Department of Clinical Research (DKF) in Basel.

DKF Basel website: How effective is remdesivir against COVID-19? Researchers from Basel present their analysis in The Lancet Respiratory Medicine

Publication in The Lancet Respiratory Medicine journal: Effects of remdesivir in patients hospitalised with COVID-19: A systematic review and individual patient data meta-analysis of randomised controlled trials

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The Swiss National Science Foundation (SNSF) has opened its ninth call for its Investigator Initiated Clinical Trials (IICT) programme. This programme supports clinical trials on underresearched topics that meet medical as well as social needs. In both their letter of intent (LOI) and their application, grant applicants must address how they actively involve or plan to involve patients and the public (PPI) in their research projects.

For researchers who are interested in applying to the IICT 2023 programme, the SCTO together with experts of the SNSF, the Department of Clinical Research Basel (DKF Basel) and the Centre hospitalier universitaire vaudois (CHUV) organised an PPI online course on 21 March. In this course, we discussed why PPI is particularly useful when planning and developing clinical trials. We also provided practical tips and examples for an effective and meaningful approach to PPI including helpful tips on how to successfully address the PPI requirement. This online course was recorded, the video is available on our website.

• Video and presentations PPI online course

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Managing a clinical study is complex and time-consuming: there are regulatory requirements to fulfil, approvals to obtain, staff to train, and partnerships to build. In order to help researchers and research teams navigate this complex world of clinical research with ease, the experts in our Project Management Platform have launched a beta version of their Easy Guide to Clinical Studies (Easy GCS).
 
The Easy GCS is structured in six study phases (from conception to completion) and eleven different subject areas (e.g. ethics and laws, study management, quality and risk, and safety). The guide not only enables researchers to quickly find answers to their questions, but it also provides references to relevant Swiss laws, to international guidelines, links to useful tools, and information on how to access additional professional support. The current beta version contains seven complete subjects.

This project is being developed by our experts in the SCTO’s Project Management Platform with support and expertise from our partners in the other SCTO Platforms, the Swiss Biobanking Platform (SBP), and the Swiss Group for Clinical Cancer Research (SAKK). It is funded by the State Secretariat for Education, Research and Innovation (SERI).

• Easy Guide to Clinical Studies (Easy GCS)
• SCTO Project Management Platform

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In order to facilitate collaboration between researchers and PPI contributors, the SCTO worked together with its multistakeholder PPI working group to create the following two new templates.

• Participation Request for PPI Activities Template

This template helps researchers as they look for potential PPI contributors for an initiative or a research project. It contains suggestions for descriptions of PPI activities, and it includes examples of the knowledge, experience, and skills that researchers would like PPI contributors to have before participating in a specific initiative or research project. In addition, information about a particular initiative or research project can be added to the template.

• Written Agreement for PPI Activities Template

Before PPI contributors engage in PPI activities, it is important to clarify the scope and duration of their engagement, their expected time commitment, and their compensation. Our template provides examples of and suggestions for aspects of a PPI partnership that should be clarified. The template can also be used to set out the basic terms and conditions of a PPI partnership, such as the overall objective of PPI contributions, confidentiality expectations for all parties, and the disclosure of potential conflicts of interests.

The SCTO worked together with its multistakeholder PPI working group to create both templates. Additional PPI resources, such as guidance for researchers and our PPI remuneration policy, can be found here: PPI resources.

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The Swiss National Science Foundation (SNSF) has opened its ninth call for its Investigator Initiated Clinical Trials (IICT) programme. This programme supports clinical trials on underresearched topics that meet medical as well as social needs. In both their letter of intent (LOI) and their application, grant applicants must address how they actively involve or plan to involve patients and the public (PPI) in their research projects.

For researchers who are interested in applying to the IICT 2023 programme, the SCTO is offering an PPI online course on 21 March. In this course, we will discuss why PPI is particularly useful when planning and developing clinical trials. We will also provide practical tips and examples for an effective and meaningful approach to PPI including helpful tips on how to successfully address the PPI requirement. This online course is free of charge and will be held in English.

• Programme and registration for the PPI online course
• More information on the SNSF’s current Investigator Initiated Clinical Trials (IICT) call

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Patient and public involvement (PPI) means that patients and members of the public contribute their personal experience with a disease to a research project by actively shaping the project’s objectives and design and by evaluating it.

In order to prepare people who are interested in participating in clinical studies as a PPI contributor, Switzerland’s national platform of the European Patients’ Academy on Therapeutic Innovation (EUPATI CH) and the Department of Clinical Research (DKF) at the University of Basel are offering a training course (in German) to become a EUPATI CH patient expert.

More information is available (in German) at EUPATI CH.

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In a press release published at the beginning of the year, the Round Table on Swiss Representation in International Organisations and Research Infrastructures (RoTIORI) from the Swiss Academy of Sciences (SCNAT) announced that Switzerland has been excluded from participating in the European Strategy Forum on Research Infrastructures (ESFRI). This is because Switzerland is no longer associated with Horizon Europe, the EU’s key funding programme for research and innovation. Switzerland's exclusion applies to its ESFRI delegation and all of its experts who had been participating in ESFRI working groups, including the Health and Food Strategy Working Group.

Every four years, the ESFRI publishes its Strategy Report on Research Infrastructures Roadmap. Since 2006, the European Clinical Research Infrastructure Network (ECRIN) has been an integral part of the ESFRI’s roadmap. Switzerland has been involved with ECRIN as an observer country since 2015, with the Swiss Clinical Trial Organisation (SCTO) serving as its representative. Moreover, Switzerland is involved in an additional 24 ESFRI roadmap infrastructures, and several highly developed research infrastructures, such as the European Organization for Nuclear Research (CERN) in Geneva, are based in Switzerland. Switzerland’s heavy involvement in European infrastructures should be reflected in political cooperation as well, which is why the SCTO supports RoTIORI’s call for swift, pragmatic solutions.

Given this situation, the SCTO is all the more encouraged that shortly before the end of last year, the National Council and the Council of States unanimously approved Switzerland becoming a full member of ECRIN. As a full member, Switzerland contributes to ECRIN's core funding and has full access to ECRIN’s services at no additional cost. In addition, Switzerland is now represented in ECRIN's Assembly of Members, so it can actively participate in decision-making. For the SCTO, one thing is clear: researchers achieve better results when they combine forces and work together. As a clinical research infrastructure, the SCTO has created a network that brings together national and international research communities from various disciplines and institutions.

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