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
Save the date: 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 details will follow.
In case of questions, please contact: Pascale Wenger (SCTO) by email or have a look at the flyer below:
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