CTU Bern (Clinical Trials Unit)

News 2017

New trial published

A randomized-controlled trial supported by CTU Bern found that symptomatic treatment of lower urinary tract infections prolongs symptom duration and is likely to be associated with an increased risk of pyelonephritis. Click to read more.

New PhD program for clinical researchers

The Graduate School of Health Sciences (GHS) of the University of Bern has introduced a new PhD program dedicated to clinical researchers. Click here to read the full article.

NRP 74 “Smarter Health Care”: Second targeted call for proposals

On 29.11.2017, the National Research Programme “Smarter Health Care” has launched a targeted call for proposals in two specific research areas.

The aim of this call is to (1) investigate the care of patients with chronic conditions at home and in the social context and (2) to optimize health care policy and management for the care for patients with chronic conditions. Click to read more.

New swissethics guideline on the appropriate period for reflection

Swissethics has recently published a guideline on the appropriate period for reflections between study information and consent to participate in a clinical trial. The guideline combines the legal context for research involving human beings with the Federal Court's practice and the practice of expert associations (fmCh) in clinical routines. In short, the guideline tries to derive guidelines for research from clinical routines. Through this approach, the guideline essentially tries to narrow down reflection periods which can be considered appropriate in research. Read more.

Two new staff members: Christina & Sheila

We are pleased to welcome two new staff members:
 
Christina will be supporting CTU as a Quality Manager.
Sheila is the newest reinforcement to our Data Management team.
 

Click here to read more.

Study published

Comparison of Kaposi Sarcoma Risk in Human Immunodeficiency Virus-Positive Adults Across 5 Continents: A Multiregional Multicohort Study

Kaposi sarcoma risk in adults who started antiretroviral therapy across the Asia-Pacific, South Africa, Europe, Latin, and North America has been compared.
Despite important antiretroviral therapy related declines in Kaposi Sarcoma incidence, men and women in South Africa and men who have sex with men remain at increased KS risk, likely due to high human herpesvirus 8 coinfection rates. Click here to read more.

SWIFT DIRECT trial: Recruitment now open

The SWIFT DIRECT trial has opened its first two sites in Bern and Lausanne. Both sites have now started recruiting patients.

The trial's main objective is to determine whether subjects experiencing an AIS due to large intracranial vessel occlusion in the anterior circulation will have non-inferior functional outcome at 90 days when treated with direct mechanical MT compared to subjects treated with bridging thrombolysis. Click here to read more.

The ELAN trial: Recruitment open!

The ELAN trial aims to estimate the net benefit of early versus late (current standard practice) initiation of direct oral anticoagulants (DOACs) in patients with acute ischaemic stroke related to atrial fibrillation. Click here to read more!

Invitation to Symposium

Extraordinary/ordinary professorship for clinical research associated with the management of the Clinical Trial Unit (CTU) at the University of Bern and the Inselspital.

Tuesday, 7th November 2017, 13:45
Auditorium Goldmann, eye clinic, entrance 48, Inselspital

Program

13:45 Introduction
Prof. Dr. med. Claudio Bassetti

13:50–14:20 Evidence-based Clinical Research
PD Dr. med. Matthias Briel, Basel (CH) & Hamilton (CAN)

14:20–14:50 Real world evidence: How to make clinical research more useful with routinely collected data
Dr. med. Lars G. Hemkens MPH, Basel (CH)

14:50–15:20 Competing risks in clinical research
PD Dr. med. Michael Koller, Basel (CH)

Break

15:40-16:10 Data science – tools for integrative clinical trials
PD Dr. med. Alexander Leichtle, Bern (CH)

16:10-16:40 The future of clinical trials
PD Dr. med. Sven Trelle, Bern (CH)

16:45 Closing words
Prof. Dr. med. Claudio Bassetti

 

New Members of Staff: Sibylle and Yanika

We are pleased to welcome two new members of staff.
Sibylle is a part of our Monitoring team. She pursued a PhD in Cognitive Neurosciences in the Laboratory for Psychiatric Neurosciences and Psychotherapy in Fribourg, after she has completed her Masters in Biomedical Sciences.
Besides supporting our Central Data Monitoring team, Yanika is studying Clinical Psychology and Social Neuroscience at the University of Bern.

Serve Study

Recruitment open!

Currently there are an estimated 300-600 adults living in Switzerland with congenital heart disease (CHD) and a right ventricle (RV) in subaortic (systemic) position. This includes adults with prior atrial switch operations for complete transposition of the great arteries (D-TGA) and adults with congenitally corrected transposition of the great arteries (ccTGA).

Although midterm survival is favorable, late outcome is compromised by ventricular dysfunction of the systemic RV, end-stage heart failure, and premature death. Currently, the only established end-stage therapy for a failing systemic RV is heart transplantation. Given the ubiquitous shortage of donor organs and the number of adults at risk, medical options to improve the fate of patients with a systemic RV are urgently needed. PDE-5 inhibition increases contractility in experimental models of RV hypertrophy, but not in the normal RV. SERVE study aim to assess the effect of PDE-5 inhibition with Tadalafil on RV size and function, exercise capacity and neurohumoral activation in adults with a systemic RV over a 3-year follow-up period.

Data management in Ebola trials

A paper that describes CTU Bern’s approach to data management in the Ebola ça suffit trials is now published.

We are pleased to welcome Markus van Oosterhout as a reinforcement to our CDM team. He is studying Science in Business Administration in his 3rd semester at the Berner Fachhochschule. He is looking forward to work with you.

Jetzt Online: Die Webseite zur geplanten Cannabisstudie in Bern (SCRIPT Studie)

Ziel der Studie SCRIPT ist es, die Auswirkungen eines regulierten Cannabisverkaufs durch Berner Apotheken zu untersuchen. Hierfür sollen zwei Gruppen verglichen werden. Die Webseite ist nun online und enthält Informationen zu geplanten Studie und zu häufig gestellten Fragen.

Den kompletten Artikel finden Sie hier.

 

Third IICT call by the SNSF

The SNSF has issued a third call for investigator initiated clinical trials on 12 July 2017. With the special programme Investigator Initiated Clinical Trials (IICT), the SNSF is promoting clinical studies in under-researched areas that do not attract industry interest. The call is limited to prospective, randomised, controlled and multicentric intervention studies.

The budget for the IICT call 2017 amounts to 10 million Swiss francs, which is sufficient to support at least four clinical trials. Read the full article here.

SAMW und swissethics veröffentlichen erste Vorlage eines Generalkonsents

Am 3. Juli 2017 haben die Akademie der Medizinischen Wissenschaften (SAMW) und die Arbeitsgemeinschaft der Schweizer Ethikkommissionen (swissethics) eine erste Vorlage des Generalkonsents publiziert. Die Vorlage Version 1/2017 wird als Empfehlung veröffentlicht.

Hier geht's zum kompletten Artikel.

2nd IICT call: SNSF approves seven projects

In August 2016, the Swiss National Science Foundation issued its second call for Investigator Initiated Clinical Trials (IICTs). The clinical researchers at the Inselspital and the University of Bern have again been successful with two approved projects. Of 35 submitted proposals, seven IICTs receive funding. Click to read more.

Clinical data sharing: new requirements published by the ICMJE

The International Committee of Medical Journal Editors believes that there is an ethical obligation to responsibly share clinical trial data. The Committee therefore remains committed to its goal: that the sharing of deidentified individual participant data becomes standard in clical resarch. On June 5th 2017, new data sharing requirements were published by the ICMJE. The requirements will become conditions for the consideration for publication of clinical trial reports in their member journals. Read the full article here.

New Member of Staff:

We are pleased to welcome Brigitta Gahl as a reinforcement to our statistic team. Before, she was working at the Inselspital in the department of cardiac and vascular surgery. Brigitta studied mathematics and philosophy in Konstanz.

Tag der Klinischen Forschung 2017

Auch in diesem Jahr findet der Tag der Klinischen Forschung mit Preisverleihung und Poster Ausstellung statt. Für die Preisverleihung können auch klinische Studien eingereicht werden.

Mehr Informationen dazu finden Sie hier.

3rd national Study Nurse / Study Coordinator Meeting

The third national study nurse/study coordinator meeting will be held on Friday, 15 September 2017, 10.00 to 17.00 h at the University Hospital Basel. More information regarding the programme and registration you can find in the flyer below.

In case of further questions, please contact: Pascale Wenger (SCTO) by email.

Cardiology Trials: Recruitment open!

Three cardiology trials started recruitment:

The high bleeding risk (HBR) patients undergoing percutaneous coronary intervention (PCI) also frequently present with risk factors for stent thrombosis and future athero-thrombotic events. Deciding on the most appropriate course of dual antiplatelet therapy (DAPT) after stent implantation remains a clinical challenge, especially after implantation of newer generation drug-eluting stents (DES). MASTER DAPT is an investigator-initiated, multi-centre, randomised clinical trial in HBR patients after PCI with Ultimaster® bioresorbable polymer-coated sirolimus-eluting stent implantation. Within current guidelines and instructions for use, the aim of the study is to compare  abbreviated versus prolonged DAPT duration after bioresorbable polymer-coated Ultimaster sirolimus-eluting stent implantation in patients presenting with HBR features. More information can be found here.

Hypercholesterolemia is a major risk factor for the development and progression of Coronary artery disease (CAD). HMG-CoA reductase inhibitors (statins) lower plasma levels of low-density lipoprotein cholesterol (LDL-C), and they reduce cardiovascular mortality in proportion to the magnitude of LDL-C lowering. While statins currently represent the first-line, gold-standard therapy for primary and secondary prevention of cardiovascular morbidity and mortality, nearly 50% of patients in Europe and Canada treated with statins do not achieve their target levels of LDL-C or cannot tolerate effective statin doses; subsequently, substantial LDL-associated residual risk remains. Experimental studies have demonstrated that proprotein convertase subtilisin/kexin type 9 (PCSK9) reduces the hepatic uptake of LDL-C by increasing the lysosomal degradation of LDL receptors. The PACMAN study aim to evaluate the Effects of the PCSK9 Antibody Alirocumab on Coronary Atherosclerosis in Patients with Acute Myocardial Infarction by means of Serial, Multivessel, Intravascular Ultrasound, Near-Infrared Spectroscopy And Optical Coherence Tomography Imaging.

The Symetis ACURATE neo/TF, a self-expandable transcatheter valve delivered via transfemoral access, gained CE mark approval in September 2014 after showing favorable procedural and short term results. The SCOPE I trial will compare its performance to the balloon-expandable Edwards SAPIEN 3, a widely used and well established transcatheter heart valve of the second generation, in a randomized fashion.

Two cardiology trials in 1 year follow up:

The 1 year follow up of BIOSTEMI study has started and will continue into 2018. Primary percutaneous coronary intervention (PCI) is considered nowadays as the reperfusion strategy of choice for patients with acute ST‐segment elevation myocardial infarction, owing to a lower risk of myocardial re‐infarction and improved short‐ and long‐term survival compared to fibrinolysis. However, STEMI is still associated with poorer clinical outcomes after PCI, compared to stable CAD (CAD), with higher rates of stent thrombosis and an increased risk myocardial re‐infarction persisting throughout long‐term follow‐up.The purpose of the study is to compare the safety and efficacy of a novel biodegradable‐polymer sirolimus‐eluting stent (Orsiro®) with a durable‐polymer everolimus‐eluting stent (Xience Xpedition or Xience Alpine®) in a superiority trial among patients presenting with acute STEMI and undergoing primary PCI. More information can be found here.

The 1 year follow up of MATRIX study was recently completed and analysis of the prolonged follow-up are underway. Bleeding in patients with acute coronary syndrome (ACS) is associated with an increased risk of long term mortality and morbidity, and this relationship is currently thought to be causal. Therefore' reducing the frequency of bleeding events while maintaining efficacy is an important goal in the management of patients with ACS. The most common site of bleeding in invasively managed patients with ACS is at the femoral artery puncture site used for heart catheterization. Minimizing Adverse haemorrhagic events by TRansradial access site and systemic Implementation of AngioX (MATRIX) study intended to compare trans-radial versus trans-femoral intervention and bivalirudin monotherapy versus current European standard of care consisting of unfractionated heparin (UFH) plus provisional use of glycoprotein IIb/IIIa inhibition via the use of one of the three available agents on the market (e.g. abciximab, tirofiban or eptifibatide) in patients (≥18 years) with ACS, that are intended for an invasive management strategy. More information can be found at ScienceDirect or NCBI.

Think Tank IICT Call 2017

Der Schweizerische Nationalfonds wird auch diesen Herbst wieder das Programm zur Förderung von Investigator-Initiated Trials auflegen. Aus diesem Grund möchten wir Ihnen die Gelegenheit bieten Ihr Studienkonzept in einer kleinen interaktiven und interdisziplinären Runde vorzustellen und zu diskutieren – egal ob Ihre Idee noch vage ist oder schon ein ausgearbeitetes Protokoll vorliegt. Einzig die Bereitschaft während 5-10 Minuten Ihr Studienkonzept vorzustellen und zu diskutieren sowie Interesse und Offenheit sich an der Diskussion zu anderen Projekten zu beteiligen ist notwendig. Sie können von Inputs und spannenden Diskussionen profitieren.

Datum:
Freitag, 30. Juni 2017, 15-17 Uhr

Ort:
CTU Bern, Finkenhubelweg 11, 3012 Bern
Seminarraum 504, EG

Moderator:
Die Gesprächsleitung übernimmt Sven Trelle zusammen mit Andreas Limacher und Felix Rintelen.

Anzahl Studien:
Maximal fünf Studienkonzepte

Anmeldung/ Fragen:
Per Mail an info@ctu.unibe.ch

New member of staff:

Besides working as a Junior Research Assistant at CTU Bern Stefan Künzler is studying Law at the University of Bern in his 4th semester.

Pilotversuch Cannabisregulierung (SCRIPT): Gesuch für Ausnahmebewilligung beim Bundesamt für Gesundheit eingereicht

Das Klinische Studienzentrum (CTU Bern) und das Institut für Sozial- und Präventivmedizin der Universität Bern (ISPM) planen in der Stadt Bern die Durchführung einer Studie zur Cannabisregulierung. Nach Vorliegen der Bewilligung durch die Kantonale Ethikkommission Bern ist nun das Gesuch um Erteilung einer Ausnahmebewilligung beim Bundesamt für Gesundheit eingereicht. Weiterlesen...

New members of staff:

Steve Berger joined the CTU team as a Clinical Data Manager since 1st of May.

Poorya Amini has a background in Veterinary medicine and did his PhD in Pharmacology here in Bern. In parallel he was doing an advance course in clinical trial management. Now he is glad to join the CTU as a Project Manager and a Central Data Monitor.

New member of staff: Pia Massatsch

We are happy to welcome Pia Massatsch as a Clinical Trial Monitor Trainee at CTU Bern.

Before joining our Monitoring & Regulatory affairs team, she has worked as a project manager, clinical trial assistant and has gained vast experience in the field of gastronomy. Pia has obtained a Master’s degree in Physics and successfully completed her PhD in Biomedical Optics at the Ecole Polytechnique fédérale de Lausanne EPFL.

NOSTONE Trial: Recruitment open!

In August 2015, the Swiss National Science Foundation launched the first call to fund Investigator Initiated Clinical Trials (IICT). One of these first round funded IICTs is the NOSTONE trial, which is supported by the CTU Bern.

The NOSTONE clinical trial is a multicenter, randomized, placebo-controlled, double-blind, parallel-group trial with the purpose to assess the efficacy of standard and low dose of hydrochlorothiazide (HCTZ) in the recurrence prevention of calcium-containing kidney stones. HCTZ 12.5 mg, 25 mg, 50 mg or placebo will be given once daily per os for 24 or 36 months to patients who had at least 2 kidney stones in the past 10 years. In addition, all patients will receive state-of-the-art non-pharmacologic recommendations for stone prevention according to current guidelines.

The investigators aim to assess the dose-response relationship for three different dosages of HCTZ on of the incidence of stone recurrences (a composite of symptomatic or radiologic recurrence). At the beginning and at the end of the trial, the presence and dimension of kidney stones will be assed using low-dose CT.

416 patients in total (104 patients per study arm) will be enrolled at 12 sites in Switzerland including University Hospitals of Basel, Bern, Geneva, Lausanne and Zürich as well as Cantonal Hospitals of Aarau, Bellinzona, Chur, Lugano, Luzern, Sion and St. Gallen.

Trial preparation started June 1st 2016. The first patient was enrolled at the Inselspital during the second week of March 2017. Trial end will be Mai 31st 2021.

More information can be found at www.nostone.ch

European Medicines Agency (EMA) has launched a new website dedicated to academic researchers

The European Medicines Agency (EMA) aims at maintaining a strong working relationship with European academics and researchers.

Collaboration between the Agency and academia is necessary for the EMA to be prepared for future challenges and opportunities offered by advances in science and technology. The EMA has therefore developed a framework to formalise, structure and further develop interactions with the academic community in the context of the European medicines regulatory network. The framework wishes to:

  • raise awareness of the mandate and work of the European medicines regulatory network to increase academia’s trust in and engagement with the regulatory system;
  • foster the translation of academic research into novel methodologies and medicines which meet regulatory standards and address needs of public and animal health;
  • ensure that the best scientific expertise and academic research are available on time to support effective evidence generation, regulatory advice and guidance, as well as decision-making in regulatory processes;
  • collaborate with academia to develop regulatory science that embraces scientific progress in medicines development without compromising patient safety, such as for example, the use of novel endpoints or novel methodologies.

The newly launched website for academia provides information on the EMA’s activities that are most relevant to academia, including news regarding current topics and events of interest.

In the section Research and development, the EMA provides:

  • Scientific and regulatory information on how to design and run clinical trials
  • Compliance standards
  • Obligations and incentives for developers of specialised medicines
  • Training resources

The full list of topics can be found here.

For more detailed information, please visit the EMA's website.

Source of information:http://www.ema.europa.eu/ema

GCP Refresher course on 19th of May

On Friday, May 19th 2017, CTU Bern offers a free half day course at the Inselspital for GCP certificate holders, who wish to refresh and update their good clinical practice knowledge. All important information can be found here.

CTU Newsletter März 2017

  • Entwicklung der ICH GCP Leitlinien
    • Qualität-durch-Design
    • Risikobasiertes Qualitätsmanagement
  • NOSTONE
  • Das CTU Statistik-Team stellt sich vor

New members of staff:

We are happy to welcome 2 new members of staff!

After her studies in Biology at the University of Zurich, Sereina Battaglia worked as Student Assistant at the Institute of Pharmacology and Toxicology and at INSERM in Paris.

Yves Etienne Bochud studied psychology in Bern. Before he joined our team we worked at the federal office of public health (BAG) in digitalization projects as well as in the data management.

Congratulations!

CTU Bern congratulates the 20 successful graduates in CAS Clinical Research Coordinator at the BFH in 2017.

More information about the next courses you can find here.

Update of the Ordinance of Clinical Trials (ClinO) following publication of the Integrated Addendum to Good Clinical Practice (GCP)

The Swiss Federal Office of Public Health (FOPH) has commenced activities to update the Ordinance on Clinical Trials (ClinO) from September 20th 2013 following publication of the integrated addendum GCP(R2) by the international conference on harmonization (ICH) in November 2016. Click to read more.

New members of staff:

We are happy to welcome three new members of staff.

Armando Lenz completed his study in biology and did his PhD in plant ecology. He is happy to be back at University and to be involved in statistical analysis and consultings of clinical trials.

Besides working as a Junior Clinical Data Manager at CTU Bern Gian-Andrea Degen is studying Medical Informatics at the Bern University of Applied Sciences in his third year.

Yannis Portmann started as a Junior Clinical Data Manager as well. He is studying Medical Informatics in Biel, he is in his last semester.

ICH asks for comments on GCP Renovation

ICH recently amended its Good Clinical Practice guideline (integrated addendum GCP(R2)). In January 2017, ICH started a new process to potentially modernize the guideline by publishing a Reflection on “GCP Renovation”. The goal of the potential renovation is to provide updated guidance that is both appropriate and flexible enough to address the increasing diversity of study types and data sources that are being employed to support regulatory and other health policy decisions, as appropriate. Stakeholders are invited to comment on the reflection paper. This public consultation is a new approach for ICH and is considered a first step in an enhancement of the ICH process.

Details on the process and the paper itself can be found here.