CTU Bern

News

New member of staff: Fabrice

27.09.2022 – We are pleased to welcome Fabrice Helfenstein as a new member of our staff at CTU Bern. Fabrice is an evolutionary ecologist by training. After a PhD in biology in Paris, he has done research in ecology,

animal ecophysiology and ecotoxicology for almost 20 years. He joined the Department of Clinical Research Basel in September 2020 where he deepened his knowledge in statistics and was involved in various research projects, from clinical trials to cross-sectional analyses of big cohorts. He will be joining our statistics team. Welcome Fabrice!

CLEVER-ACS: Results published

02.09.2022 – The CLEVER-ACS randomized clinical trial was published in the Journal of the American College of Cardiology (Randomized Trial of Early mTOR Inhibition in Patients with Acute ST-Segment Elevation Myocardial Infarction).

CLEVER-ACS was a randomized, multicenter, international, double-blind, placebo-controlled trial. CLEVER-ACS investigated whether mTOR inhibition using everolimus in patients with ST-elevation Myocardial infarction undergoing percutaneous coronary intervention (e.g. stenting) could reduce myocardial infarct (MI) size and improve left ventricular remodeling, compared to a placebo treatment. Click here to read more.

SWIFT-DIRECT: Results published

12.07.2022 – Results of a global trial treatment on thrombectomy in stroke patients were published in The Lancet. The randomized controlled trial SWIFT-DIRECT was designed to assess whether thrombectomy alone is

non-inferior to intravenous alteplase plus thrombectomy for treating acute stroke patients with large vessel occlusions. The primary outcome was functional independence at 90 days, defined as a score of ≤2 on the modified Rankin scale. An absolute risk difference of −12% was pre-specified as non-inferiority margin.
Click here to read more.

SCTO Annual Report 2021

05.07.2022 – SCTO's digital annual report offers you an overview of their main achievements in 2021. The SCTO invites you to dive deeper into the highlights of their Clinical Trial Unit (CTU) Network, their platforms, and their Executive Office.

Click here to read the annual report.
For more information about the organisation, please visit their website: www.scto.ch

New member of staff: Zoé

30.06.2022 – We are pleased to welcome Zoé Peña as a new member of our staff at CTU Bern. Zoé studied chemical engineering at KIT in Karlsruhe and has a background in biopharmaceutical processing.

She contributed to the creation and management of a clinical registry for the intervention of cardiac chronic total occlusions at Kantonsspital St. Gallen. She will be joining our Monitoring team. Welcome Zoé!

CTU Newsletter Juni 2022

23.06.2022
-  CTU Bern 2021 in Zahlen
-  Ausgewählte Publikationen mit CTU-Beteiligung aus
   den letzten 3 Monaten
-  Nächste Kurstermine

ECRIN: survey for multinational clinical project proposal training

13.06.2022 - ECRIN and some of its national partners are

working on a training series that will focus on supporting researchers to develop proposals for European calls that are open to multinational trials. It is planned that there will be a special emphasis on the Horizon Europe calls.

To better adapt the training to the needs of the research community, ECRIN has developed a short survey. They would be very grateful if you take 10 minutes to share with them your experience and challenges and desire to participate in future clinical trial Horizon Europe proposal submissions.

Link to the survey: https://survey.ecrin.org/surveys/?s=8W7MMX8TY7LFPJTM

TMBE Scholarship program is now open for applications

01.06.2022 - Applications to the Scholarship program for the MAS Translational Medicine and Biomedical Entrepreneurship 2022/2024 are now open. The scholarship covers the entire program for outstanding scientists or inventors with translational projects/ideas for the development of new drugs, biologics or medical devices.

Deadline for the application is June 25. More information can be found here.

SCTO is looking for a new Managing Director

19.05.2022 - Annette Magnin will hand over her position as Managing Director of the SCTO to new hands at the end of November 2022. With immediate effect the SCTO will start looking for a suitable successor.

For more information about the organisation, please visit their website: www.scto.ch

EU call for proposals

17.05.2022 - The 2022 EU Cancer Mission calls have just been published. Swiss-based researchers are eligible to apply as Associated Partners but cannot coordinate a consortium. If successful, funding for Swiss participation will come from Switzerland.

HORIZON-MISS-2022-CANCER-01-03: Pragmatic clinical trials to optimise treatments for patients with refractory cancers. The deadline for submission is 7 September 2022. Further information can be found here.

CLINICAL TRIAL ACADEMY Essential Course: Clinical trial protocol design & optimization

11.05.2022 - This course includes a fundamental education on clinical trial protocol components, hands-on protocol design, and direct interactive sessions with trial experts to deepen technical understanding of

participants and enable them to develop an ideal clinical trial protocol.
Link to the course: https://www.risklick.ch/essential-program

Note that Risklick offers a special price for startups coming with partners recommendation. Click here to read more.

DIFU started enrollment

27.04.2022 - DIFU is a multicenter and randomized study conducted in multiple hospitals in Switzerland and Germany. The study aims to demonstrate that immediate revascularization on top of standard wound care leads to reduced cardiovascular and limb events including improved ulcer healing compared to standard wound care alone in patients with non-critical lower extremity arterial disease (LEAD) and Diabetic Foot Ulcer (DFU).

CTU Bern is highly involved in this trial with the following divisions: Clinical Study Management, Statistics & Methodology, Data Management, and Monitoring. Further Information can be found here.

SCTO Symposium 2022: 15 June 2022, 10:00–16:15, Lugano

27.04.2022 - Data science, artificial intelligence (AI), and machine learning (ML) are buzzwords we come across nearly everywhere when looking at innovative technologies in medicine. This symposium addresses the

use of these technologies specifically for clinical research to find out where we are today and where we should be heading.
The symposium will be held in English.

You can register online by 30 May 2022 at www.scto.ch/symposium.

The PACMAN-AMI trial was recently published in JAMA

05.04.2022 – The results of the PACMAN-AMI randomized controlled trial were recently published in the Journal of the American Medical Association.

The trial compared the addition of a lipid-lowering drug (Alirocumab, a PCSK9 inhibitor) to high-intensity statin therapy on lipid plaque development in coronary arteries of patients with acute myocardial infarction. Please click here to learn more.

CAS Clinical Reserach Coordinator

05.04.2022 – Register now for the CAS Clinical Research Coordinator which will start in September 2022. Click here to read more.

SCTO Risk Based Monitoring Score Calculator goes live

23.03.2022 – In collaboration with the SCTO Monitoring and Statistics and Methodology Platforms, we are pleased to announce a new tool for determining the appropriate degree of monitoring to use for a trial.

The Risk Based Monitoring Score Calculator is a simple to use web based application based on Shiny (an extension of the R language). It presents a wide range of risks, suggests the degree of monitoring that might be relevant for your trial and then allows you to download a PDF report detailing the information you have entered and the recommendation. See the SCTO Tools page for additional information.

CTU Newsletter März 2022

17.03.2022
-  Shiny Apps und ihr Potential als Werkzeug zum Wissenstransfer – Gesundheits- und Sozialverhalten der Schweizerischen Bevölkerung während der Coronavirus

   Pandemie…   …und ein Beispiel wie Shiny Apps Wissenstransfer unterstützen
-  Ausgewählte Publikationen mit CTU-Beteiligung aus den letzten 3 Monaten
-  Nächste Kurstermine

SCTO online course: "PPI in a nutshell"

10.03.2022 – The Investigator Initiated Clinical Trials (IICT) 2022 call of the Swiss National Science Foundation (SNSF) requests that applicants address their approach to patient and public involvement (PPI) both in their letter of intent (LOI) as well as in the application itself.

To support clinical research professionals who are considering applying for an IICT 2022 grant with the rather new PPI requirement, the SCTO will provide an online course „PPI in a nutshell“ on two different dates:

  • 12 April 2022, 13.00 - 15.00
  • 6 May 2022, 9.00 - 11.00

Participation in this online course is free of charge, but registration is compulsory. The course language is English.

For more information and registration please check the SCTO website.

SNSF IICT Call Deadline: 20th May, 2022

02.03.2022 – The IICT programme is targeted at researchers who wish to conduct an investigator initiated clinical trial. Applicants must submit a letter of intent (LOI) via mySNF by 20 May 2022.

Please contact us for a consulting so we can support you in developing your study idea: 
info@ctu.unibe.ch

Experience tells us, that early involvement of a CTU considerably improves the quality of proposals. Writing of IICT call proposals is labor-intense (but rewarding and fun). More information on the call can be found here.

New member of staff: Corentin

07.02.2022 - We are pleased to welcome Corentin Wicht as a new member of staff here at CTU Bern. Corentin completed a Bachelor in Psychology followed by a Master in Cognitive Neuroscience at the University of Fribourg. In 2018, he was offered a career grant from the Swiss National Science Foundation to conduct a PhD thesis on the Neural Correlates of Placebo Effects at the Neurology Unit of the University of Fribourg. Since February Corentin works as a Clinical Data Manager at our Data Management Team. Welcome Corentin!

STREAM started enrollment

31.01.2022 – STREAM is a multicenter, randomized,
non-inferiority trial conducted in multiple hospitals
in Switzerland.

The trial investigates the effects of discontinuing statin therapy compared to continuing statin therapy in multimorbid elderly adults without clinical cardiovascular disease (CVD).
CTU Bern is highly involved with Clinical Study Management, Statistics & Methodology, Data Management, and Monitoring. Further Information can be found here.

No to the popular initiative to ban animal and human studies

21.01.2022 – The voting on the popular initiative that wants to ban all animal and human research in Switzerland as well as new therapies resulting from such research will be on 13 February 2022. The SCTO has already taken its position and recommends a clear „no“. Please see their position statement here.

Federal Office of Public Health (FOPH): Statistical Report and Activity Report 2020

05.01.2022 – The FOPH published two reports:

Human Research in Switzerland 2020:
Descriptive statistics on research covered by the Human Research Act (HRA):

Activities of the Research Ethics Committees 2020:
Summary Report of the Coordination Office for Human Research (Kofam):

Direktion Lehre und Forschung – 3 offene Stellen

05.01.2022 – Die Direktion Lehre und Forschung der Insel Gruppe hat drei interessante Stellen zu besetzen:

New in-hospital mortality prediction model for patients treated in the intensive care units

20.12.2021 – Researchers from a multinational collaboration between intensive care units from Finland, Estonia and Switzerland developed and validated a new in-hospital mortality prediction model.

Click here to read more.

 

CTU Newsletter Dezember 2021

10.12.2021 – Rückblick 2021

  • Datenmanagement
  • Statistik & Methodologie
  • Monitoring
  • Qualitätsmanagement
  • Nächste Kurstermine

SAKK Event Lay Summaries of Clinical Study Results

18.10.2021 – The SAKK Patient Advisory Panel is organizing an event on 20 November 2021 to discuss lay summaries of clinical trial results.

The registration for this event is now open. For more information please click here.

Funding opportunity - Patient-directed clinical trials

01.10.2021 – This year, Swiss Cancer Research (SCR) is celebrating 30-years of research funding. In parallel, Rising Tide Foundation for Clinical Cancer Research (RTFCCR) is having a 10-year celebration. To mark these milestones, they have launched a joint call for proposals to fund a jubilee award. Visit their website to find out more about this funding opportunity.

University Library Bern launches new Research Information System with Data Repository

29.09.2021 – BORIS Portal has been officially launched. BORIS Portal allows researchers at the University of Bern to archive and manage research data, projects and fundings, to make it accessible and clearly identifiable.

For more information check the website of the University Library Bern.

CTU Newsletter September 2021

24.09.2021

  • RISKLICK –  Datengeschützte Entwicklung
    von klinischen Studienprotokollen
  • News von der SCTO:
    - Roundtable SCTO –  swissethics –  Swissmedic
    - Statistik-Plattform
  • Nächste Kurstermine

MASTER DAPT: results just published

31.08.2021 – Results of a global trial on dual antiplatelet therapy after percutaneous coronary artery intervention were published in The New England Journal of Medicine on 28th of August 2021.
More information can be found here.

Software developed at CTU Bern

25.08.2021 - Besides building databases and analysing projects, staff at CTU also develop software to ease our work and make us more productive.

Specific projects might also result in a technique that is of interest to others. In the spirit of Open Science, we make these software packages, mostly R packages but also Stata packages, available to any interested parties on our GitHub site. The "Software developed at CTU Bern" page on the CTU Bern website gives details of the packages and provides links to get more information on the individual packages.

SCTO's PPI Guide for Researchers

22.07.2021 - The SCTO „PPI Guide for Researchers“ offers support for researchers when they start planning a project and apply for potential funding.
DE: https://www.scto.ch/de/stakeholders/researchers.html
EN: https://www.scto.ch/en/stakeholders/researchers.html

Final results of the OPERAM trial now published

22.07.2021 - We are happy to announce that the final results of the OPERAM trial have been published by the BMJ. CTU Bern was involved in Statistics, Data Management, Project Management and Monitoring.
The paper is accessible online here: BMJ

 

swissmedic Online-Veranstaltung: Informationen zur neuen Medizinprodukte-Regulierung

21.07.2021 - Die neue Medizinprodukte-Regulierung ist

seit dem 26. Mai 2021 in Kraft und anwendbar. Hauptziele der neuen rechtlichen Vorgaben sind die Verbesserung der Produkte- und somit der Patientensicherheit sowie die Erhöhung der Transparenz. Mehr Informationen zur Online-Veranstaltung finden Sie auf der Website von swissmedic.

CTU Newsletter Juni 2021

29.06.2021

  • Was ist mit Swiss Medtech passiert?
  • ... mehr als nur neue Vorschriften
  • Risikokategorien für klinische Studien
  • Nächste Kurstermine

New legislation – Clinical Investigations with Medical Devices

10.05.2021 – On 26th May 2021, the European Regulation (EU) 2017/745 on medical devices (MDR) will become fully applicable. As a consequence, the legal requirements for clinical investigations with medical devices are changing.
More information can be found here.

ECRIN International Clinical Trials Day 2021

07.05.2021 – In light of the current pandemic, ECRIN is organising a virtual event for International Clinical Trials Day (ICTD) on May 20th, 2021.

ICTD 2021 will bring together stakeholders from across Europe and the globe to discuss the growing interest in platform trials from best practices to challenges in the European context. ICTD is open to research organisations, clinical research professionals, patient organisations, regulatory and ethics bodies, funders and industry.
More information can be found here.

Medical devices: Lost in translation?

10th SCTO SYMPOSIUM - 8 June 2021, online

Together with Bern University Hospital, the University of Bern, and sitem-insel AG (Swiss Institute for Translational and Entrepreneurial Medicine), the SCTO is holding its 10th symposium on 8 June 2021.

https://www.scto.ch/en/event-calendar/symposium/symposium-2021.html

Shiny App implementation of the COVID-19 Social Monitor

The COVID-19 Social Monitor is a population-based online survey which informs the public, health authorities, and the scientific community about relevant aspects and potential changes in social and health behavior during the COVID-19 pandemic in Switzerland. As of March 2021, 14 survey waves have been conducted since the first survey in March 2020. Click here to read more.

CTU Newsletter März 2021

  • VACCELERATE –  ein Netzwerk, das für die Koordination und Durchführung von COVID-19-Impfstoffstudien in Europa geschaffen wurde
  • Nächste Kurstermine

CTU Bern becomes national coordinator of the European project VACCELERATE

VACCELERATE is a network created for the coordination & execution of COVID-19 vaccine Trials in Europe, currently involving 214 clinical trial sites in 30 countries. The project plans to address key questions of interest outside the big registration trials, such as vaccine efficacy in virus variants, trials in children, pregnant women, immunocompromised patients, trials on combination of different vaccines and others. Click here to read more.

ReproducibiliTea

In October 2020 the Swiss Reproducibility Network (SwissRN) was founded. It is a peer-led consortium that aims to promote and ensure rigorous research practices in Switzerland. Within the network universities form nodes that organise different activities. At the University of Bern we want to initiate a journal club which will give you the opportunity to get a gentle intro to matters of good scientific practice or, along the way, more advanced discussions in a cross-disciplinary setting - paired with your favourite beverage. Click here to read more.

SNSF IICT Call Deadline: 25th May, 2021

The IICT programme is targeted at researchers who wish to conduct an investigator initiated clinical trial. Applicants must submit a letter of intent (LOI) via mySNF by 25 May 2021.

Please contact us for a consulting so we can support you in developing your study idea: 
Contact form

Experience tells us, that early involvement of a CTU considerably improves the quality of proposals. Writing of IICT call proposals is labor-intense (but rewarding and fun). More information on the call can be found here.

Schweizer Gesundheitsstudie

1000 Proband*innen sind das Ziel bis Ende 2021 – Der Einschluss geht weiter!

Die Schweizer Gesundheitsstudie soll Aufschluss über die Gesundheit der Schweizer Bevölkerung geben.

Langfristiges Ziel ist es insbesondere, den Einfluss von Umweltfaktoren, Chemikalien, Lebensstil und Infektionskrankheiten wie z.B. COVID-19 auf die Gesundheit allgemein und die häufigsten Volkskrankheiten zu untersuchen.

Klicken Sie hier für weitere Informationen.