MASTER DAPT trial: 1850 patients enrolled
Up to now, 1850 high bleeding risk (HBR) patients with coronary artery disease (CAD) have been successfully enrolled in the MASTER DAPT trial in 96 sites around the world. Click to read more.
Eine vor kurzem im BMJ publizierte Studie hat aufgezeigt, dass weniger als 50% der klinischen Versuche, welche im EU Clinical Trials Register (EUCTR) registriert sind, ihre Ergebnisse öffentlich zugänglich machen.
Diesem Thema nimmt sich nun ein Feature im Wissenschaftsmagazin des SRF2 an. Mehr lesen.
Fundamental Concepts in Epidemiology
CTU Newsletter September 2018
- Umgang mit Daten
- Rechte der Studienteilnehmenden
- Widerruf der Einwilligung
- Anonymisieren der Daten
- Löschen der Daten
- General Data Protection Regulation
- News von den SCTO-Plattformen
- Nächste Kurstermine
Three cardiology trials came to a conclusion
Three large randomized cardiology trials came to a conclusion recently: the GLOBAL LEADERS, MATRIX and Bioscience Orsiro trials. CTU Bern was involved in all three trials. Click here to read more.
The BISS trial: Recruitment now open!
Botox Instead of Strabismus Surgery
Today a majority of patients who suffer from a large angle ocular misalignment require a surgical intervention to regain binocular vision. Many of those surgeries are made during childhood. Strabismus surgery has a high success rate and few complications, but it requires anesthesia of about 45 minutes and makes future surgeries less predictable and technically more difficult. Click here to read more.
New Member of Staff: Kathrin
Kathrin has joined our Quality Assurance and Monitoring team at the beginning of August. Click here to read more.
The second national Congress for Study Nurses and Research Coordinators will take place at the NH Hotel in Fribourg on Friday, October 26th, 2018.
To view the program and to find out how to register, click here.
The Federal Council submitted a draft legislation article for cannabis pilot trials for consultation
The Federal Council submitted a draft legislation article for cannabis pilot trials for consultation. This article and a corresponding act regulates the conduct of scientific studies in the field of recreational cannabis use. The article does not affect regulations of cannabis use outside of such scientific studies. Read more
New member of staff
Melanie joined our Data Management Team in July. She studied biology at the University of Zurich and works as a trial coordinator at the Inselspital. Welcome Melanie!
CTU Newsletter Juni 2018
- News von den SCTO-Plattformen
- Das Quality Management stellt sich vor
- Nächste Kurstermine
New members of staff
Besides working as a junior research assistant at CTU Bern, Lea is studying Social Anthropology at the University of Fribourg. Welcome Lea!
Stephanie will support the CTU Bern as a junior research assistant. She received a Bachelor's Diploma in Psychology in 2016 at the University of Bern. Welcome Stephanie!
Data Management Plan: Writing Labs & Individualized Consulting
Since October 2017, researchers have to submit a data management plan (DMP) to the SNSF in the course of a grant application. The University of Bern offers a set of services for everyone who needs to write an SNSF Data Management Plan for the October deadline. Click here to find out more about the support services.
New member of staff
We are happy to welcome Philippe as a reinforcement of our central data monitoring team in CTU Bern. He obtained a BA in history this winter and is now studying towards his MA-degree at the University of Bern.
New member of staff
Sylvain will be supporting CTU as a statistician. Sylvain did is PhD at the University of Bern and moved on with the postdoc at the University of Aberdeen. Welcome Sylvain!
New members of staff:
Irina will be supporting CTU as a statistician. Irina did her PhD in statistics at the University of Geneva and the postdoc at Duke University. The last five years she worked as statistician at Nestlé Institute of Health Sciences. Welcome Irina!
Before joining our statistician team in the beginning of May Mikael worked as a consultant in the pharmaceutical industry in Basel. He has previous experience from clinical research projects form the Fraunhofer-Chalmers Center for industrial mathematics and Swiss Paraplegic Research in Nottwil. Welcome Mikael!
New Member of Staff:
Mamatha will be supporting CTU as a Central Data Monitor. Mamatha did her Master in Biotechnology in Mannheim and her PhD in Functional genomics at the German Cancer Research Center (DKFZ) in Heidelberg. Welcome Mamatha!
New project website released
Do you know hereditary thrombotic thrombocytopenic purpura (hTTP)?
Likely not, because hTTP is an ultra-rare disease, affecting only around one person out of a million. In Bern at the Inselspital, one of the largest patients cohorts of this disease, the Hereditary TTP Registry, is maintained. To reach out to more patients and their clinicians to join the Hereditary TTP Registry, a new public website has been released recently. Click to read more.
Evaluation of second IICT call: intensive preparations required
In 2015, the SNSF has started a special program to promote Investigator Initiated Clinical Trials (IICT). The funding for IICTs continues to be in high demand. In the recently published evaluation of the 2016 call, the SNSF addresses main reasons for the rejection of applications. Click to read more.
PragMagic Online Tool
The PragMagic Tool aims to support trial design teams to maximize generalizability of trial findings to the routine care setting of interest while ensuring validity and operational feasibility of the trial. It has been developed with the support of CTU Bern and the Insititute for Social and Preventive Medicine of the University of Bern. Read more.
New study published
A prospective multicenter cohort study, supported by CTU Bern, has shown that elderly patients with acute venous thromboembolism have a substantial long-term risk of recurrent venous thromboembolism and that recurrence carries a high case-fatality rate. Only two factors were independently associated with recurrent venous thromboembolism. Read more.
Mitral regurgitation is a frequent condition leading to relevant mortality and morbidity in elderly patients. More information can be found here.
Cardiology Trial: Recruitment open!
Reduction of low-density lipoprotein cholesterol (LDL-C) levels effectively reduces the risk of adverse events in patients with established atherosclerotic cardiovascular disease. Click here to read more.
2. D|A|CH Symposium in Zürich
Der 2. Dreiländerkongress für Klinische Prüfungen findet am 11. & 12. Juni 2018 in Zürich statt. Der von den Koordinierungszentren für Klinische Studien in Deutschland, Österreich und der Schweiz (D-A-CH) organisierte Kongress, richtet sich an alle, die im klinischen Bereich tätig sind. Klicken Sie hier für weitere Informationen.
New version of CDISC Glossary released
The CDISC glossary is a comprehensive resource for definitions related to clinical research. It is based on authoritative sources and contains definitions of over 650 terms. The newest version of the CDISC Glossary is linked to the National Cancer Institute NCI Thesaurus. Click to read more.
Start of second cohort in April 2018
New staff members:
We are pleased to welcome two new staff members:
Sevil will be supporting CTU as a Central Data Monitor and Michael is the newest reinforcement to our Data Management team. Click here to read more.
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
Comparison of Kaposi Sarcoma Risk in Human Immunodeficiency Virus-Positive Adults Across 5 Continents: A Multiregional Multicohort Study
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
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)
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
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
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.
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.
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.
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.
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.
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.
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.
Freitag, 30. Juni 2017, 15-17 Uhr
CTU Bern, Finkenhubelweg 11, 3012 Bern
Seminarraum 504, EG
Die Gesprächsleitung übernimmt Sven Trelle zusammen mit Andreas Limacher und Felix Rintelen.
Maximal fünf Studienkonzepte
Per Mail an firstname.lastname@example.org
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
CTU Newsletter März 2017
- Entwicklung der ICH GCP Leitlinien
- Risikobasiertes Qualitätsmanagement
- 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.
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.
Financial support for research databases of the Inselspital
As of 1.1.2017, CTU Bern will again be able to give a discount for research databases of the Inselspital Bern. The discount amounts to up to CHF 3’000.- per study and can be used for studies that are not industry sponsored. The funds are taken from the core funding that the CTU Bern receives from the Direktion Lehre und Forschung (DLF) of the Inselspital. Insel researchers can find details on the funding on the Insel Intranet.
OPERAM trial now open for recruitment
The OPERAM trial funded by a HORIZON 2020 grant started recruitment this week at the Department of Internal Medicine at the Inselspital Bern.
ICH adopted the Integrated Addendum to the Good Clinical Practice (GCP) Guideline
On November 30th, 2016 the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) announced the adoption of the Integrated Addendum to the Good Clinical Practice (GCP) Guideline E6(R2). ICH states that the “guideline has been amended to encourage implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, recording and reporting while continuing to ensure human subject protection and reliability of trial results”. The amendment will now be implemented by ICH members through national and regional guidance. Read more.
Central Data Monitor (60 - 100%)
As Central Data Monitor at CTU Bern, you will be a part of the Quality Assurance and Monitoring workflow.
Clinical Research Associate (Monitor/in) 80-100%
Zur Verstärkung unseres Teams suchen wir per 1. Dezember 2016 oder nach Vereinbarung eine/n Clinical Research Associate (Monitor/in) 80-100%.
Clinical Data Manager (60-80%)
To reinforce the existing team we are currently looking for a Clinical Data Manager (60-80%).
To reinforce the existing team we are currently looking for a Clinical Data Manager (60-80%).
New member of staff: Marie Roumet
After completing her studies in biology and ecology with a focus on genetics and biostatistics at the University of Montpellier, Marie completed a PhD in plant biology. Afterwards, she worked as a postdoctoral researcher at the ETH Zürich for more than 4 years. She joined CTU as a Senior Statistician and will replace Roger Schürch who will be leaving CTU soon taking on a position as assistant professor at Virginia Tech, Blacksburg/VA.
New Certificate of Advanced Studies in Clinical Epidemiology
21.11.2016 - The University of Bern offers a new Certificate of Advanced Studies in Clinical Epidemiology. Participants will learn the necessary methods to plan, conduct and communicate clinical research projects.
Click to read more.
Call for Entries: SPRINT Data Analysis Challenge
In order to demonstrate the potential benefits of clinical trial data sharing and transparency, the New England Journal of Medicine (NEJM) has launched the SPRINT Data Analysis Challenge. The Challenge encourages healthcare professionals, researchers and scientists from around the world to use the dataset underlying the SPRINT report, plus any other publicly available dataset, to identify a novel scientific or clinical result. Read more
Recommendations for the construction and use of health-related registers
Registers with reliable data are becoming increasingly important in the healthcare sector. To contribute to the quality assurance, the organizations ANQ, FMH, H+, SAMW and unimedsuisse have jointly published recommendations for the construction and use of health-related registers. These include minimum standards for example on data protection and data quality. You can find The recommendations here.
CTU Newsletter September 2016
New template for Annual Safety Report of IITs available
26.10.16 - Swissethics has published a new template of the Annual Safety Report for Investigator initiated trials (IITs) under the Clinical Trials Ordinance (ClinO). The template can be found and downloaded on the website of swissethics.
25.10.16 - What is a Site Delegation & Signature Log and what purpose does it serve? Read more
SNSF issues second call for Investigator initiated clinical trials (IICT)
First IICT call: Three approved projects at the Inselspital Bern
22.07.16 - In August, the SNSF has launched the first call for independent, Investigator Initiated Clinical Trials (IICTs). With three approved applications, the clinical researchers at the Inselspital Bern have been highly successful. CTU Bern closely collaborates with the Inselspital in two approved projects. Read more
GCP Refresher course on 7th of June
25.05.16 - On Tuedsay, June 7th 2016, 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.
Results of CTU customer survey now available!
23.03.16 - In January and February 2016, CTU Bern conducted a survey among customers from the Inselspital. The results of this survey are now available. Read more
SCTO Symposium 2016:
Building up the future generation of clinical researchers
29.04.16 - Leading experts and stakeholders will discuss on 16 June 2016 in Lausanne the current opportunities and challenges as well as future perspectives to promote young physicians in the field of clinical research. Register now! Read more
The Lancet: Paracetamol ‘not clinically effective’ in treating osteoarthritis pain or improving physical function
Source of the following press release: The Lancet journals, London - 17.03.2016
In a large-scale analysis of pain-relief medication for osteoarthritis, researchers find that paracetamol does not meet the minimum standard of clinical effectiveness in reducing pain or improving physical function in patients with knee and hip osteoarthritis. Although paracetamol was slightly better than placebo, researchers conclude that, taken on its own, paracetamol has no role in the treatment of patients with osteoarthritis, irrespective of dose. Read more
Tocilizumab effective for patients with giant cell arteritis
21.03.2016 - Giant cell arteritis is an immune-mediated disease of medium and large-sized arteries that affects mostly people older than 50 years of age. The study aimed to assess the efficacy and safety of tocilizumab in the first randomised clinical trial in patients with newly diagnosed or recurrent giant cell arteritis. Read more
CTU Lecture am 8.3.2016:
«Praktische Tipps und Hinweise zur Studienregistrierung»
07.03.16 - Sven Trelle, Kodirektor der CTU Bern, informiert Sie an der kommenden CTU Lecture über die wichtigsten Dos and Don'ts sowie die gesetzlichen Rahmenbedingungen, die Sie bei der Registrierung von klinischen Studien beachten sollten.
Die Folien zur Präsentation von Sven Trelle finden Sie hier.
Have your own Study Website
02.03.16 - The CTU Bern Data Management Team is offering a new service to support your study or project.
Whether to promote your study, to provide information to patients or to communicate with your sites, a website is a great tool to reach your target audiences. We can help you to establish your own project Website based on our pre-selected WordPress Templates with minimal costs. Feel free to contact us to discuss further about your future study/project website. For more information, click here.
Umfrage am Inselspital:
Ihr Feedback zählt!
05.02.16 - Die CTU Bern ist bestrebt, den klinisch Forschenden am Inselspital bestmögliche Unterstützung bei Ihren Studienprojekten bieten zu können und das Dienstleistungsangebot entsprechend den Bedürfnissen weiter zu optimieren:
Durch die Umfrage wollen wir herausfinden, wie zufrieden Sie mit unseren Dienstleistungen und Mitarbeitenden sind und in welchen Bereichen wir uns weiter verbessern können, um die patientenorientierte klinische Forschung am Forschungsplatz Bern noch gezielter zu fördern.
Wir bitten Sie, sich 10 Minuten Zeit zu nehmen und an unserer Online-Befragung teilzunehmen: Hier geht's zur Umfrage.
CTU Lecture am 2.2.2016: «Forschungsverträge: Was gilt es zu beachten?»
27.01.16 - Dr. sc. nat. ETH Daniel Gisi, Technology Transfer Manager bei Unitectra, der Technologietransfer-Organisation der Universitäten Basel, Bern und Zürich stellt in seinem Referat Typen von Forschungsverträgen vor, die am Inselspital abgeschlossen werden und gibt wertvolle Tipps, worauf bei der Aushandlung von Verträgen geachtet werden muss.
In der anschliessenden Diskussion können Sie Ihre Fragen stellen und eigene Erfahrungen mit dem Experten und den anwesenden Kolleginnen und Kollegen austauschen.
Wir freuen uns auf Ihre Teilnahme!
Die Folien zur Präsentation von Herrn Dr. Gisi finden Sie hier.
CTU Lecture am 12.1.2016:
«KEK Anträge: Wie reiche ich einen KEK Antrag korrekt ein? - Tipps und Tricks von der KEK Generalsekretärin»
05.01.2016 - Wir freuen uns, Ihnen das Referat von Frau Dr. sc. nat. Dorothy Pfiffner, Leiterin des Sekretariats der Kantonalen Ethikkommission Bern KEK, ankündigen zu dürfen: Am 12. Januar 2016 wird Frau Dr. Dorothy Pfiffner im Rahmen der CTU Lectures über häufige Rückstellungsgründe von Forschungsanträgen berichten sowie über die wichtigsten Anforderungen und Bedingungen der KEK referieren. Die CTU Lecture bietet Ihnen zudem die Gelegenheit, Fragen und Anliegen rund um das Thema Anträge der KEK direkt zu kommunizieren. Die Teilnahme ist kostenlos und ohne Voranmeldung möglich.
Weitere Informationen finden Sie hier.
New GCP courses recognized by swissethics
18.12.2015 - Both GCP courses provided by CTU Bern, Basic and Advanced, were completely revised according to the new requirements stipulated by swissethics. Both courses have received formal recognition by swissethics. Read more
CTU Lecture am 8.12.2015:
«Wer weiss denn sowas?»
CTU Quiz zur klinischen Forschung
Testen Sie ihr Wissen im Themenbereich der klinischen Forschung im CTU Weihnachtsquiz am Inselspital. Um live beim Quiz in REDCapTM mitspielen zu können, benötigen Sie ein internetfähiges Mobiltelefon oder Ihren Laptop. Das Mitspielen ist selbstverständlich freiwillig und nicht Voraussetzung für die Teilnahme an der Lecture.
Weitere Informationen zur Veranstaltung finden Sie hier.
CTU Lecture am 10.11.2015:
«Update zur Biobank des Inselspitals»
Am kommenden Dienstag, 10. November 2015 findet die zweite CTU Lecture am Inselspital statt.
Sie sind herzlich eingeladen am Vortrag «Update zur Biobank des Inselspitals» von Herrn PD Dr. med. Alexander Leichtle, Oberarzt am Universitätsinstitut für Klinische Chemie UKC, teilzunehmen.
Weitere Informationen zur Veranstaltung finden Sie hier.
New services on Inselspital campus:
CTU Lectures & CTU Sprechstunde/Consulting
As of October 2015 CTU Bern offers new regular services for all clinical researchers and study personnel on the Inselspital campus: the CTU Sprechstunde and the CTU Lectures. Read more
CTU Newsletter September 2015
Die neuen Kodirektoren der CTU Bern - Kuratorium -
Aktuelles aus den Arbeitsbereichen - CTU Lectures -
Kursangebot - Die nächsten Kurstermine
Ebola vaccine tested successfully for the first time
A vaccine against the Ebola virus, tested in West Africa for the first time in a field trial, has proved to be effective according to the first interim analysis published today in The Lancet. CTU Bern together with the ISPM was heavily involved in designing and conducting the World Health Organization (WHO) «Ebola ça Suffit» vaccine trial. Read more
6th Symposium of the Swiss Clinical Trail Organisation SCTO: Clinical Nursing – Medical Research
The 6th Symposium of the Swiss Clinical Trail Organisation SCTO will take place at Kantonsspital St. Gallen on Wednesday, June 17 2015. This year's symposium will address the topic “Clinical Nursing – Medical Research: Interfaces in clinical research – a convergence of two disciplines”. Read more
GCP Refresher Course at the Inselspital on Tuedsay, 9th of June
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. Read more
Ebola Vaccine Trials in Guinea
The number of Ebola Virus Disease cases continues to fluctuate in Guinea. At the same time phase 1 studies of vaccine candidates have produced promising immunogenicity and safety results. These vaccines now need to be evaluated further for safety, efficacy and effectiveness. Read more
Peter Jüni is the new professor of primary health care in Bern
ISPM Director, Prof. Dr. Peter Jüni, will be leaving to become the new chair of primary health care and director of the Bernese Institute of Primary Health Care (Berner Institut für Hausarztmedizin, BIHAM) on 1st December, 2014. Prof. Dr. Matthias Egger will resume the post of ISPM Director. We wish them both well. Read more
Study Talk – zum Thema GCP Inspektionen
Einladung an alle klinisch Forschenden des Inselspitals
Dienstag, 28. Oktober 2014, 13-17 Uhr,
Pathologisches Institut, Hörsaal 7 Auditorium Langhans.
One Year of the Human Research Act: Opportunities and Challenges for the future
Save the date! FOPH symposium, 27 January 2015, 13:15–17:00, Hotel Bern, Bern
Modern technologies for revascularisation superior to medical therapy in patients with stable coronary artery disease
Two related articles published today simultaneously in the New England Journal of Medicine and the Lancet. Read more
Neue HFG Hotline
Das neue Humanforschungsgesetz (HFG) hat die gesetzlich festgelegten Anforderungen an klinische Forschungsprojekte deutlich erhöht. Klinisch Forschende werden neu von der CTU mit einem erweiterten Angebot bei klinischen Forschungsprojekten unterstützt. Mehr lesen
Study Talk - Wissensaustausch
Study Talk - Wissensaustausch von Study Nurses, Studienkoordinatorinnen und -koordinatoren des Inselspitals Bern. Mehr lesen
Advanced GCP & clinical research course
Due to the high volume of interest and the number of requests, we have extended the registration period for the advanced GCP & clinical research course. Participants are limited to a maximum of 50! Read more