CTU Bern

News

Simpl’HIV Trial: The first SNSF IICT trial with major involvement of CTU Bern published

CTU Bern contributed to the study design, provided the electronic case report form and trial database, monitored the German-speaking sites, and conducted the statistical analysis.                                                                                                                                                                                       Click here to read more.

 

How to address sex and gender bias in medical research

Understanding how sex and gender interact enhances the quality of science, health, and medicine. Covid-19 is an excellent example of this. We are therefore very pleased to announce the start of the continuing education course CAS in Sex- and Gender-Specific Medicine (www.gender-medicine.ch) with several speakers from ISPM in March 2021. Click here to read more.

New members of staff: Pia and Leonhard

We are pleased to announce that Pia Massatsch is back at CTU Bern. Pia studied physics in Stockholm and at the EPFL, where she received a PhD in biomedical optics in 2003. Education wise she has added a DAS in Management of Clinical Trials at the university of Geneva in 2017 and is currently doing a CAS CARAQA (Clinical Affairs, Regulatory & Quality for medical devices) at Heig-VD (Yverdon). In parallel to her employment at the CTU she is a co-founder of the start-up machineMD, developing diagnostic devices in the field of neuro-ophthalmology. Welcome back Pia!

We are also pleased to welcome Leonhard von Meyenn as a new member of staff here at CTU Bern. He received his PhD in Immunology from the University of Bern in 2019. During his time at the Inselspital, he gained experience in clinical research and now joins our Monitoring Team at the CTU this month. Welcome Leonhard!

New members of staff: André, Jean-Benoît and Ulf

We are pleased to welcome André Moser as a new member of staff. He received his PhD in Statistics from the University of Bern in 2011. Before André joined our Statistics team he worked for the the team of Milo Puhan at the Epidemiology, Biostatistics and Prevention Institute at the University of Zurich for three years. Welcome André!

We are also pleased to welcome Jean-Benoît Rossel as a new member of staff. Together with André he joined our Statistics team at the beginning of October. Jean-Benoît studied Mathematics at EPFL and did his PhD with Prof. Robert Dalang in the Chair of Probability (2008 – 2013). After one year as a postdoctoral researcher in this same group, he joined Lausanne University Hospital (CHUV) in 2014 as a Statistician. Welcome Jean-Benoît!

Last but not least we are pleased to welcome Ulf Schreiber as a new member of staff. Ulf worked as Co-head of care in interventional cardiology at the Heartcenter Hirslanden Bern. In the last 5,5 years he was working at the emergency department for adults at the Inselspital Bern. Within this time he also finished his study to an expert in emergency care NDS/DAS. Ulf joined the Clinical Investigation team as new team-member and head of study coordination. Welcome Ulf!

SNSF funds 3 clinical trials from Bern within the 2019-IICT-Program-Call

The Swiss National Science Foundation overall funds five clinical trials within the 2019 call of the IICT program, three of which were submitted by researchers from the University of Bern/Inselspital and all supported by CTU Bern.
Click here to read more.

“presize”: precision based sample size calculation

Sample size calculations are an important part of clinical research. Too few participants and the study objectives cannot be fulfilled; too many participants can be a waste of resources.

Basically, there are two methods to calculate the sample size. Click here to read more.

New member of staff: Carmen Jörg

We are pleased to welcome Carmen as a new member of staff here at CTU Bern. Before she joined our Clinical Investigation Team at sitem-Insel this month, she was working as a nurse. Carmen also started with the CAS "Clinical Research Coordinator" at the Berner Fachhochschule this September.

CTU Newsletter September 2020

  • Wie künstliche Intelligenz COVID-19-Forscherinnen und Entscheidungsträger unterstützen kann
  • News von den SCTO-Plattformen
  • Nächste Kurstermine

4th Congress of the Swiss Professionals of Clinical Research Coordination

The SPCRC invites you to the 4th congress which will take place at the Hotel Einstein in St. Gallen on Friday, November 13th, 2020.

Click here to read more.

 

SCTO statement on Popular Initiative "For moderate immigration"

"No" to the Limitation Initiative – Preserve favourable conditions for research and innovation in Switzerland

 

On 27 September 2020, the Swiss electorate will vote on the popular initiative called “For Moderate Immigration” (Limitation Initiative). This initiative calls for ending the free movement of people between Switzerland and the European Union, which is guaranteed by the Agreement on the Free Movement of Persons (AFMP). Click here to read more.

COVID-19 AI tool to support researchers 

Scientists are drowning in COVID-19 papers. By one estimate, the COVID-19 literature published since January has reached more than 34,000 papers and is doubling every 20 days among the biggest explosions of scientific literature ever. Click here to read more.

Bewilligung CI als interdisziplinäre SISF-Forschungsplattform

sitem-insel Support Fonds (SISF)

Mit der Zulassung der Clinical Investigation (CI) als interdisziplinäre Forschungsplattform können Forschende ab der laufenden Antragsrunde SISF-Beiträge für Leistungen der CI beantragen.

https://www.unibe.ch/forschung/forschungsfoerderung/uniinterne_foerdergefaesse/sisf/index_ger.html

BIOTOK Randomized Clinical Trial

Wearing shoes specifically designed with a novel sole (biomechanical footwear) significantly reduces the pain associated with knee osteoarthritis.

Click here to read more.

New member of staff: Eva Joho

After graduating in Applied Economic Analysis and working for the research department at the Federal Office for Agriculture Eva joined the data management team in May. As a clinical data manager she will design, review and test study database setups on secuTrial and REDCap.

CORON-ACT started enrollment

Today, the CORON-ACT trial started. The trial evaluates the effects of Tocilizumab in patients with progressing COVID-19. Click here to read more.

 

SNSF IICT Call Deadline: 26th May, 2020

The platform for this year’s SNSF IICT Call is open for submission of letters of intent since April 1st.
Please get in touch with us for a consulting now to discuss any idea for a clinical trial.

For the sixth time, the SNSF is launching a call for clinical studies on topics that are outside the industry focus. The process has been adapted and SNSF has set new requirements.
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.

Regulatory Affairs Watch Issue 3

In this issue:

  • Latest measures to combat COVID-19
  • Collaborating on the General Consent, the key success factor
  • News from Unimedsuisse and swissethics
  • General consent
  • Considerations in paediatrics
  • Innovative procedures
  • Patient organisation

www.scto.ch/raw

CTU Newsletter März 2020

  • Klinische Studien in Zeiten der COVID-19-Epidemie
  • SCTO-Plattform-Event 2020
  • SCTO, Swissmedic und swissethics Roundtable
  • Update zu Regularien für klinische Versuche mit Medizinprodukten
  • Nächste Kurstermine

Medical devices: lost in translation?

10. SCTO-SYMPOSIUM - AUF 2021 VERSCHOBEN

Gemeinsam mit dem Universitätsspital Bern, der Universität Bern und sitem-insel AG, dem Schweizerischen Institut für Translationale und Unternehmerische Medizin, organisiert die SCTO ihr jährliches Symposium.

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

CTU Newsletter Dezember 2019

  • Zentrales Monitoring in klinischen Studien
  • CAS «Clinical Research Coordinator»
  • 10 Jahre SCTO – Jubiläumsprojekt
  • News von den SCTO-Plattformen
  • Nächste Kurstermine

The SCTO is celebrating its 10-year anniversary this year!

"People. Data. Biosamples. Clinical research – at eye level"

The SCTO is celebrating its 10-year anniversary. They dedicate this special occasion to dialogue among the various contributors in clinical research: Everyone should find a place for exchange at the SCTO, to jointly advance this important field of research in Switzerland.

The anniversary website is available at: www.10years.scto.ch

The SCOPE I trial was recently published in the Lancet

The SCOPE I trial was recently published in the Lancet, comparing 30 days outcomes of the self-expandable ACURATE neo transcatheter aortic valve replacement device versus the balloon-expandable EDWARDS SAPIEN 3 transcatheter aortic valve replacement device, using the transfemoral access route.
Click here to read more.

CTU Newsletter September 2019

  • Quelldatenliste (Source Data Location List)
  • Umzug ins sitem-insel
  • Nächste Kurstermine

The EVOPACS trial was recently published in the JACC

EVOPACS was an investigator-initiated, double-blind trial comparing Evolocumab vs Placebo treatment in the management of LDL levels, on the background of a high-intensity statin treatment of 40mg atorvastatin. The primary endpoint was calculated LDL-C reduction (%) over an eight week time period. The mean difference in calculated LDL-C change was -40.7% in favour of Evolocumab compared to Placebo. 2mt Ulm provided the Webspirit Data capture system, CTU Bern was involved in Data Quality surveillance and Statistical analyses. See for further reading: http://www.onlinejacc.org/content/early/2019/07/31/j.jacc.2019.08.010

The primary endpoint analyses of the BIOSTEMI trial were recently published in the Lancet

It used a Bayesian analysis to combine data from a previous trial (BIOSCIENCE, STEMI subgroup) with the data newly acquired. Two stents were compared, an ultra-thin strut drug eluting stent vs a thin strut drug eluting stent, randomisation and data acquisition were done in the Webspirit system (2mt Ulm). CTU Bern was involved in planning of the trial, data quality checks and statistical analyses. For further reading and the commentary, see Lancet: paper comment

3rd Congress of the Swiss Professionals of Clinical Research Coordination (SPCRC)

The 3rd congress of the Swiss Professionals of Clinical Research Coordination will take place at the Hotel Olten on Friday, November 08th, 2019.
 

CTU Bern is now ISO 9001:2015 certified

In the first quarter of 2019, the CTU Bern had its QMS externally evaluated, assessed and certified with regards to the services offered. As such, the CTU Bern is successfully ISO certified since April 2019. The certification to the ISO 9001:2015 Standard on Quality Management System includes the CTU services Project Management, Consulting, Data Management, Statistics, Monitoring and Regulatory Affairs.
Click here to read more.

Online course for systematic reviews and meta-analysis

A new, online, introductory training course on how to conduct a systematic review of interventions. 10 hours of self-directed learning on searching, risk of bias, meta-analysis, GRADE and the complete systematic review process, developed by world-leading experts in systematic review methods.
Click here to read more.

CTU Newsletter Juni 2019

  • CTU Bern 2018 in Zahlen
  • ISO 9001:2015 Quality-Management-System-Zertifizierung
  • News von den SCTO-Plattformen
  • Nächste Kurstermine

Special Seminar, 28 May 2019

Retiring statistical significance: why and how? Join the discussion 4 to 6 pm at Mittelstrasse 43, room 224
Click here to read more.

Regulatory Affairs Watch issue 1, April 2019

Dear clinical research investigators, partners, and friends,
The Swiss Clinical Trial Organisation is delighted to share with you the first issue of Regulatory Affairs Watch.
Click here to read more.

Announcement of Investigator Initiated Clinical Trials (IICT) Call 2019

For the fifth time, the SNSF is launching a call for targeted funding of investigator-initiated clinical studies that are outside the industry focus.
Submission deadline: 01/Nov/2019

If you are interested, please contact us early on for a consulting: info@ctu.unibe.ch 
Click here to read more.

CTU Newsletter März 2019

  • Was sind Quell-Daten/Source Data und Quell-Dokumente/Source Documents?
  • REDCap Light  ̶  ein neuer Service der CTU Bern
  • News von den SCTO-Plattformen

 

EVOPACS Trial: Recruitment completed!

A total of 308 patients have been successfully enrolled in the EVOPACS trial. The final follow up visits will occur within next 8 weeks. Click here to read more.

Bern Center for Precision Medicine (BCPM)

Request for applications

First Call for Pilot Projects

The BCPM is soliciting applications for one-year pilot projects. The primary goal is to support innovative translational research projects that address key challenge areas in Precision Medicine.

Request for applications and application form you can find here

CAS Clinical Research

Certificate of Advanced Studies in Clinical Research
in Health Care Organisations (CAS CRHCO) 2019/2020

Still free places!

Read more here

CTU Lecture Februar 2019:
«50 oder 500 Studienteilnehmende? Prinzipien der Sample Size Berechnung erklärt»

Donnerstag, 14. Februar 2019
12.45 - 13.30 Uhr
André Schroeder Auditorium, zmk bern (Eingang 51a)
Referent: PD Dr. med. Sven Trelle, Direktor, CTU Bern
Wir freuen uns auf Ihren Besuch!

Wissenschaftscafé Bern und Thun

Was genau bedeutet translationale Medizin und was will damit erreicht werden? Welche Chancen und auch Gefahren bringt diese Herangehensweise mit sich? Welche Prozesse müssen eingehalten werden, damit Forschungsergebnisse im Spital umgesetzt werden können? Was ist die Sitem-Insel und wie wichtig ist sie für den Forschungs- und Wirtschaftsstandort Bern?

Announcement of Investigator Initiated Clinical Trials (IICT) Call 2019