The SCTO is pleased to announce an upcoming online seminar, organised by the Regulatory Affairs Platform and Education Platform, focusing on the latest changes to the Human Research Act (HRA) regulations. The amended ordinances enter into force on 1 November 2024.

This one-hour seminar will provide an important update for all clinical research professionals and will offer key insights into the new regulatory changes.

The seminar will take place on Monday, 28 October, from 12.00–13.00.

The Zoom link for this seminar is available for download on the SCTO Platforms website.

Don't miss out on this valuable learning opportunity!

Between September and December 2024, four additional sessions will be offered, providing essential insights and practical knowledge for observational and further-use projects.

The sessions will focus the following topics:

• BASEC – A practical walk-through for HRO projects
• Mastering Consent: Key insights into general and informed consent for HRO projects
• Data sharing and open research data – details for HRO projects
• Sample management and biobanking – essentials for HRO projects

The sessions are held online as a Zoom meeting and offer plenty of time for you as researchers to ask questions.

Participation is free of charge and the sessions will be held in English.

Register here for this interesting sessions: Seminar series: Facts and pitfalls of observational studies – How to plan and conduct HRO projects

The twelfth SCTO Symposium was dedicated to the topic "Working towards efficient clinical data-driven research in Switzerland" and took place in Lausanne on Tuesday, 11 June.

We had the chance to listen to insightful presentations on the present and future of data-driven clinical research, given by inspiring speakers from all over Switzerland. Each session led to a fruitful discussion between the speakers and the audience on these hot topics.

The Symposium was being organised by the SCTO and the Clinical Research Center (CRC) in Lausanne. 170 participants attended the event.

A short summary of the various presentations and the slides can be found at SCTO Symposium 2024.

On 5 June 2024, a motivated group of young Swiss paediatric researchers met in Sursee for the NextGen Research Day, an official pre-programme to the annual pédiatrie suisse congress. The NextGen Research Day is organised by the Swiss Research Network of Clinical Pediatric Hubs (SwissPedNet) with the support of the Swiss Clinical Trial Organisation (SCTO). 29 participants attended this event. The participants were resident pediatricians, senior pediatricians, master students, PhD students, postdocs as well as researchers from other related fields such as pediatric psychology or pediatric nursing.

The NextGen Research Day included several workshops where the young paediatric researchers were able to participate in small groups and learn from a professional in the field: A speed-dating session with experts and a scientific escape room where the participants had to solve a clinical research challenge. Over lunch and coffee breaks, there were many lively discussions between participants and with the experts.

This year was the first time, the NextGen Research Day was organised and communicated as an official pre-programme to the annual pédiatrie suisse congress on 6 June and 7 June 2024. We hope that the communication at the congress and the excellent quality of the 2024 event will help us to reach an even a wider audience for the NextGen Research Day 2025.

We thank Pfizer AG, Novartis Pharma Schweiz AG, AbbVie Inc. and Eli Lilly (Suisse) S.A. for their financial support.

Medical science could never progress without clinical trials. Too often, however, these trials ignore the needs of the patients themselves. All that is now about to change.

There is great value in patient and public involvement (PPI) in clinical research because patients living with a particular disease or condition have an understanding and knowledge that can help develop and improve healthcare.

However, Switzerland is still in the early stages of development of patient and public involvement. “If our trials become more patient-friendly, it might also become easier to recruit enough trial participants in future, and keep them on board too” (Sabine Rütti Roch, SCTO).

That's why the SCTO has developed different resources for patient representatives and clinical researchers, and aims to develop a platform that brings researchers and patients together.

Read this interesting article from Horizons Magazine, to which the SCTO contributed.

In 2023, the SCTO and its network continued their mission to enable high-quality clinical research. In our Annual Report 2023, you can read about all the important activities that took place in our different key areas.

Here are some of our highlights from 2023:

• Our CTU Network was involved in more than 2,000 clinical research projects and trained over 8,000 clinical research staff.
• SCTO Platforms developed and shared five new tools and six publications with the clinical research community.
• Patient and public involvement (PPI) was included in various Certificate of Advanced Studies (CAS) programmes, and the European Patients’ Academy on Therapeutic Innovation (EUPATI) Switzerland held its first patient expert training.
• Switzerland became a full member of the European Clinical Research Infrastructure Network (ECRIN), allowing the Swiss research community full access to ECRIN’s services.
• Over 400 participants attended our six events.

In the upcoming year, the SCTO will pursue its mission to the research community by fostering and intensifying collaboration between national research infrastructures, by strengthening the Clinical Trial Unit (CTU) Network, and by increasing the harmonisation of clinical research through tools, guidelines, and relevant services.

Click here to read the Annual Report.

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 2024, 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 2024.

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.

Clinical trial registries are established tools widely used in clinical research. Registration rates of clinical trials have increased, however, there remains a substantial underreporting of observational studies. A survey across eight European countries belonging to the European Clinical Research Infrastructure Network (ECRIN) was conducted to assess the status of national developments with respect to registries for observational clinical trials. The SCTO actively contributed to this survey, which was additionally targeted at the needs and requirements for sharing of individual participant data (IPD) from clinical trials/clinical studies.

Six out of the eight countries included in the survey reported on national registries activities for observational or health studies. The authors of the survey suggested that a first step of improvement could be to integrate the national registries with ECRIN’s clinical research Meta Data Repository (crMDR), covering all primary registries of the World Health Organization’s International Clinical Trials Registry Platform (ICTRP) plus ClinicalTrials.gov, Pubmed and some repositories for sharing of IPD.

Read the complete study Survey by ECRIN about national registries for observational studies and sharing of individual participant data, Christian Ohmann et al., Zenodo, published on 25 March 2024.

The Swiss National Science Foundation (SNSF) has opened its tenth 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 2024 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 18 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

Sharing health data for research requires the alignment of numerous factors, including regulation, access, interoperability, standardisation, and collaboration between researchers and patients. In Switzerland, like elsewhere, this process encounters various hurdles and bottlenecks, not only at the international level or with third parties but also within Swiss Universitiy Hospitals.

The recently published article, featured in Swiss Medical Weekly, sheds light on the legal, ethical, and technical challenges surrounding data sharing in Switzerland. The interview study was co-authored by our SCTO Regulatory Affairs Platform members Claudia Becherer and Elke Hiendlmeyer, in collaboration with several organisations including the Health and Policy Lab at ETH Zurich, the Swiss Personalized Health Network (SPHN), the Swiss Biobanking Platform and the Bern Center for Precision Medicine.

The majority of stakeholders surveyed in semi-structured interviews believe that the most complex and confusing aspects of data exchange do not lie in the actual data transfer itself, but in the associated processes and systems. The uncertainties relate to data protection laws, data ownership issues and processes for anonymisation and pseudonymisation. The study concludes that facilitating data access and exchange in Switzerland primarily requires further legal clarification, training and investment in sustainable infrastructures.

What are the bottlenecks to health data sharing in Switzerland? An interview study by Kelly E. Ormond et al., published on 22 January 2024 im Swiss Medical Weekly

This year’s SCTO Symposium is dedicated to the topic «Working towards efficient clinical data-driven research in Switzerland» and will take place in Lausanne on Tuesday, 11 June. 

The volume and complexity of data generated in clinical research have increased considerably due to several factors. The ways in which clinical trial data are generated, managed, and shared (data ‘’flows’’ in a clinical trial) have all become increasingly important for achieving efficient outcomes in both national and multinational trial settings.

Join us at the SCTO Symposium to navigate challenges faced by clinical researchers, the SCTO’s clinical trial units (CTUs), data centres, and biobanks in this current environment. We will address a range of related topics – including regulatory considerations, IT and infrastructure requirements, data governance, data sharing.

The symposium is being organised by the SCTO and the Clinical Research Centre (CRC) in Lausanne. It will be held in English.

Visit our event website for more information, we look forward to meeting you there!

Programme and registration: SCTO Symposium

NextGen Research Day is an innovative training event for young researchers and doctoral students in the field of paediatric clinical research. The event is being organised by SwissPedNet, the Swiss Research Network of Clinical Pediatric Hubs. At the event, participants will find out what knowledge and skills are needed to conduct clinical studies and research projects, and they will get the tools they need to successfully run their projects.

When? 5 June 2024
Where? Cantonal Hospital Lucerne

Registration and further information NextGen Research Day 2024

The Swiss National Science Foundation (SNSF) has opened its tenth call for its Investigator Initiated Clinical Trials (IICT) programme. This programme supports clinical trials on under-researched topics that meet medical as well as social needs. One of the programme’s requirements is that grant applicants state in both their letter of intent (LOI) and their application how they actively involve patients and the public (PPI) in their research projects.
 
On 18 March, the SCTO is offering an online course on these PPI requirements to researchers who would like to apply to the SNSF’s IICT 2024 programme. In the course, we will give participants examples and practical tips on how to successfully address the IICT’s PPI requirements. This online course is free of charge and will be held in English. Please register online.
 
The portal mySNF is open for IICT submissions as of mid-April 2024. Applicants must submit an LOI by 27 May 2024. Applications must be submitted by 1 November 2024.

• Programme and registration for the SCTO’s online course (in English):
  IICT 2024 Application: How to Successfully Address the PPI Requirement
• More information on the IICT 2024 call

The new lunch seminar series, developed by the SCTO’s Education Platform, provides a concise overview of the qualitative, regulatory, and legal requirements for conducting and planning observational studies (projects subject to the Human Research Ordinance (HRO)).

Four online sessions are scheduled to take place from March to May and are now open for registration. Please note that these sessions are free of charge and will take place in English.

More information and registration: Seminar series: Facts and pitfalls of observational studies – How to plan and conduct HRO projects

With patient and public involvement (PPI), 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 its design and by evaluating it.

In order to prepare individuals who are interested in participating in designing and evaluating 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, for the second time, their training course to become a EUPATI CH patient expert (held in German). The first course was successfully concluded in December 2023, and the second course will take place in April 2024 (registration deadline: 15 March).

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

This year’s trinational symposium on clinical trials in Germany, Austria, and Switzerland (D|A|CH) will take place on 16 and 17 September in Berlin.

The fourth D|A|CH symposium features beginner and advanced programme sessions with over 50 speakers and experts from three countries. Topics include clinical trial regulation, patient involvement, patient education, decentralised trials, workforce shortages, data protection, medical devices, and much more. The SCTO is part of the programme committee, and members of the SCTO Network will participate as speakers at this year’s D|A|CH symposium.

This event will take place in German. Early-bird registration with a price reduction is open until 28 February.

For more information, the programme, and registration, visit the D|A|CH symposium’s website.

During the SCTO’s annual forum on 31 January 2024, in Bern, we delved into the complex regulatory environment of clinical research and addressed the revision of the ordinances related to the Human Research Act (HRA). Together with our 78 participants, we explored the hot topics sparked by this revision that ignited insightful discussions.

PDFs of the slides from presentations are available on our website: SCTO Forum 2024.

The SCTO Symposium 2024 will take place in Lausanne on 11 June 2024. Together with the Clinical Research Centre (CRC) Lausanne, the SCTO is holding this year’s symposium on the topic of working towards efficient clinical data driven research in Switzerland.

The event will take place in English. Make sure to mark your calendar for June 11 – registration opens soon!

The below linked article published in the latest issue of the Swiss medical bulletin Schweizerische Ärztezeitung explores the participation of patients in the Swiss healthcare system.

The SCTO contributes significantly to Patient and Public Involvement (PPI) in academic clinical research. We support numerous PPI projects in Switzerland by providing trainings and developing PPI resources.

Read the article online: Teilhabe braucht einen Dialog auf Augenhöhe (Involvement Requires a Dialogue on Equal Terms) by Adrian Ritter, published on 24 January 2024, in the Swiss Medical Journal. (in French and German)

Learn more about SCTO PPI resources and PPI Mapping online.

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