News 2022

Director of DCR: Eva Segelov (Hoffman)

12.12.2022 – We are pleased to welcome Eva Segelov as Head of the Department of Clinical Research (DCR). Since 1 December 2022 she helds the position of the Full Professor for Clinical Research and Director of the Department of Clinical Research at the Medical Faculty of the University of Bern and University Cancer Center, Inselspital. Please click here to read more.

Federal Office of Public Health (FOPH): Statistical Report and Activity Report 2021

30.11.2022 – The FOPH published two reports:

Human Research in Switzerland 2021:
Descriptive statistics on research covered by the Human Research Act (HRA):

BAG_Statistikbericht_2021.pdf (PDF, 2.5 MB)

Activities of the Research Ethics Committees 2021:
Summary Report of the Coordination Office for Human Research (Kofam):

BAG_Jahresbericht_2021_A4_DE_def.pdf (PDF, 418KB)

BAG_Jahresbericht_2021_A4_EN_def.pdf (PDF, 398KB)

BAG_Jahresbericht_2021_A4_FR_def.pdf (PDF, 404KB)

BAG_Jahresbericht_2021_A4_IT_def.pdf (PDF, 394KB)

Report on the evaluation of the SCTO’s CTU Network and platforms

03.11.2022 – The Swiss Clinical Trial Organisation (SCTO) is a research infrastructure committed to promoting high-quality, patient-oriented clinical research in Switzerland.

The SCTO is an independent, non-profit organisation funded by the State Secretariat for Education, Research and Innovation (SERI) and the Swiss National Science Foundation (SNSF), and it has been mandated to advance academic clinical research in Switzerland by serving as a nationwide collaboration platform and international networking partner. The SERI commissioned an independent evaluation of the SCTO’s Clinical Trial Unit (CTU) Network and platforms for the time period of 2017–2020. The recently released evaluation report (available in German) summarises the results of the evaluation, presents initial conclusions, and identifies action points.

Report on the evaluation of the SCTO’s CTU Network and platforms (in German) (PDF, 967KB)

StOP? II trial started enrolment

24.10.2022 – The StOP? II trial started recruitment in October 2022. This is a cluster randomized clinical trial to test the effects of the implementation of a toolbox for structured communication in the operating room vs usual care, to reduce mortality.

Operations are performed by a multidisciplinary team of surgeons, anesthetists and nurses and remains associated with mortality.
Further information can be found on the project website.

Extension of the study on COVID-19 booster in pregnant and lactating women

20.10.2022 – The study on safety monitoring of COVID-19 vaccines in pregnant and lactating women, called the "Covid Vaccine Monitor" study, has been extended until end of November 2022.

Pregnant and lactating women who have been vaccinated with a first, second or third booster in the last 48 hours can register for this study at: http://www.covidvaccinemonitor.eu

The primary objective of this study is to generate and compare incidence rates of adverse reactions of different COVID-19 vaccines reported in pregnant and lactating women, through online questionnaires.

5th Congress of Swiss Professionals of Clinical Research Coordination (SPCRC)

05.10.2022 – The 5th congress of the Swiss Professionals of Clinical Research Coordination will take place at the Hotel Kreuz in Bern on Friday, 11 November 2022.

A faculty of renowned speakers will address crucial topics and enhance our knowledge in important areas of our professional work. The friendly and relaxed attitude of the congress will give you the great opportunity to informally meet speakers and colleagues, discuss challenges we are facing in daily work, and exchange ideas. In addition, you have the opportunity to become a member of the Association of Swiss Professionals of Clinical Research Coordination. Click here to read more.

Open Science Support

05.10.2022 – The Open Science Team offers training and support in questions related to writing Data Management Plans (DMP), as well as a DMP review service. Submit your DMP here

Watch the new video modules and slides (DMP-Videos and slides) how to meet Swiss National Science Foundation requirements related to Data Management Plans or click here to read more.

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

CTU Newsletter Juni 2022

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

CTU Newsletter Juni 2022 (PDF, 959KB)

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

Job advertisement (PDF, 64KB)

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.

CAS Clinical Research Coordinator (PDF, 267KB)

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

CTU Newsletter März 2022 (PDF, 515KB)

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.

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.