In news from our network, the University Hospital Basel has announced the publication of the INQUIRE framework, a first of its kind set to optimise patient-oriented clinical research, internationally. This framework initiated by the University of Basel and University Hospital Basel, brings together the best of thinking from 7 stakeholder groups across 16 countries who took part in a rigorous Delphi process to distil their combined expertise into distinct steps.

It outlines how to apply 6 quality dimensions (building blocks) to each stage of the lifecycle of a study. This accessible step-by-step INQUIRE framework can make futile, wasteful research become obsolete.

The full article,"Academic response to improving value and reducing waste: A comprehensive framework for INcreasing QUality In patient- oriented academic clinical REsearch (INQUIRE)", is available through open access from PLOS Medicine.

Find out more at the Department of Clinical Research, University of Basel.

You can also download the framework summarised as a user-friendly graphic guide.   

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In line with our goal of supporting the successful development of new therapies and improving existing treatments, the SCTO has established eight platforms. These platforms are to serve as centres of excellence and focus on eight key fields: auditing, data management, education, project management, monitoring, regulatory affairs, safety, and statistics and methodology. 

Each centre of excellence consists of a team with expertise, skills, and knowledge related to one key aspect of clinical research. Their members aim to not only provide leadership and to share resources, but also to inspire one another, revitalise their fields, and keep apace with trends and best practices.

To find out more about the platforms, their concrete projects and who is involved with them, browse our Fact Sheet under SCTO Platforms.

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With the "Young Talents in Clinical Research" program, the SAMS and the Gottfried and Julia Bangerter-Rhyner Foundation aim at encouraging young medical doctors to venture into clinical research.

For the period 2017 – 2020, CHF 1 million per year is made available by the Bangerter Foundation to support young physicians working in Switzerland with “protected time for research” and “project grants”.

The next submission deadline is 30 June 2018. The participation requirements can be found at www.samw.ch.

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The Swiss Medical Weekly recently published "The impact of clinical trial units on the value of clinical research in Switzerland".

This study draws upon expertise and reflection from the SCTO and the CTU Basel, as it is authored by Dr Belinda von Niederhäusern, formerly with the CTU Basel, SCTO managing director Annette Magnin and new president of SCTO Prof. Christiane Pauli-Magnus.

“A decade ago, Swiss stakeholders established constructive initiatives to improve the quality of clinical research, including a national Clinical Trial Unit (CTU) Network, predominantly rooted in university hospitals. At the 10th anniversary of this network (2007–2017), we reflect on the CTUs’ trajectory and review whether – and how – they have been successful in improving the value of clinical research conducted in Switzerland.”

Access the full article under www.scto.ch.

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The Swiss Ethics Committees on research involving humans (swissethics) have released a more comprehensive form for the reporting of serious adverse events (SAEs) for medicinal products in clinical trials.

The template follows relevant international guidelines.
To download the template, visit www.swissethics.ch.

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Members of the conect4children (c4c) initiative have launched a large collaborative paediatric network to facilitate the development of new drugs and other therapies for the entire paediatric population in Europe.

The conect4children (collaborative network for European clinical trials for children) consortium aims to enhance the competitiveness of Europe for developing medicines for children by using existing expertise, patient access, and developing common processes to be applied to disease natural history studies, registries, studies of new therapies, and comparisons of existing therapies. 

This consortium is a novel collaboration between academic and private sectors that includes 33 academic and 10 industry partners from 20 European countries, more than 50 third parties and around 500 affiliated partners. The Swiss Research Network of Clinical Pediatric Hubs (SwissPedNet) serves as the Swiss contact. The six-year project is a pioneering opportunity to build capacity for the management of multinational paediatric clinical trials across Europe while ensuring the voices of children, young people, and their families are heard.

Read the full press release under conect4children.org

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At its 9th General Assembly on 23 April 2018, the Steering Board of the Swiss Clinical Trial Organisation (SCTO) elected Prof. Christiane Pauli-Magnus, formerly serving as vice-president, as the new president of the SCTO.

She is Co-Head of the Department of Clinical Research and Head of the Clinical Trial Unit at the University Hospital Basel. Prof. Pauli-Magnus accepted her appointment as president with immediate effect.

We wish to express warm thanks to Prof. Gregor Zünd, President of the University Hospital Zurich Executive Board, for his dedicated, successful service as president of the SCTO.

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Subsequent to several incidents and scandals relating to medical devices, the EU has revised its current medical device legislation.

The EU Commission has proposed two new, more stringent Ordinances to replace the previous Directives: one for medical devices and the other for in vitro diagnostics. The proposed revisions should ultimately improve quality and safety of medical devices and harmonise their implementation in the EU, thereby enhancing their safety for patients.

Due to a Mutual Recognition Assessment between Switzerland and the EU market, Switzerland must follow suite, proposing adaptations to its legal framework so that Swiss-based patients can also benefit from better patient safety and greater transparency regarding medical devices. Accordingly, the Therapeutic Products Act (TPA) and the Human Research Act (HRA) must also both be adjusted. The Federal Council is calling for public input on these two acts. The deadline for submissions is 11 June 2018.

Relevant documentation is available from the Federal Office of Public Health website in French, German, and Italian, plus an overview in English. Please consult our tables in French and German, summarising proposed changes to the TPA and HRA.

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The CORBEL partners launch an Open Call for Advanced Research Projects and offer all academic and industrial scientists in Europe the unique chance to accelerate their research.

CORBEL is an initiative of thirteen new biological and medical research infrastructures (BMS RIs) and has received funding from the European Union’s Horizon 2020. Supported by the Open Call project managers, successful applicants will be offered open access to cutting-edge technologies and services available at more than 20 service providers from 10 European research infrastructures.

For more information about the call and the application process view the flyer below or visit www.corbel-project.eu.

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Funding for "Investigator initiated clinical trials" (IICT) continues to be in high demand. But preparing applications requires intense preparations.

With the special IICT programme, the Swiss National Science Foundation (SNSF) is promoting clinical studies in under-researched areas that do not attract industry interest. Projects of the first call in 2015 will be completed in 2019.

The SNSF has now published the evaluation results of the 2016 call, listing the successful projects as well as the main reasons why the other proposals were rejected. Read the evaluation at www.snf.ch.

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A multi-stakeholder task force developed a consensus document on providing access to individual participant data from clinical trials. The task force used a broad interdisciplinary approach after examining major issues associated with sharing of individual clinical trial data.

The adoption of the recommendations in this document would help to promote and support data sharing and reuse among researchers, adequately inform trial participants and protect their rights, and provide effective and efficient systems for preparing, storing and accessing data. The recommendations now need to be implemented and tested in practice. Further work needs to be done to integrate these proposals with those from other geographical areas and other academic domains.

This consensus-building process involved a wide range of experts like researchers, patient representatives, methodologists, information technology experts, and representatives from funders, infrastructures and standards development organisations. The project was coordinated by the European Clinical Research Infrastructure Network (ECRIN), thus, the focus was on non-commercial trials and the perspective mainly European.

Read the full article at bmjopen.bmj.com.

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In its 8th Forum “Clinical Research” on 31 January 2018, the SCTO followed the topical thread of its last Symposium: "Creating greater value and efficiency in clinical research". Close to 90 participants attended the successful event in Bern.

A summary report of the Forum 2018 will follow shortly. The presentations can be accessed as of now under Forum 2018.

The SCTO regularly organises events in order to shed light on current issues and challenges in clinical research from a Swiss perspective and to find common solutions.

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With the increasing globalisation of medicines development, the International Council for Harmonisation (ICH) adopted a major Guideline on the planning and design of multi-regional clinical trials at its meeting in mid-November 2017.

The ICH E17 Guideline will facilitate the acceptability of multi-regional clinical trials as part of global regulatory submissions in ICH and non-ICH regions. This is expected to have a direct public health benefit, in particular by encouraging more predictability and planning security around the approval of trials and the use of clinical trial data from a greater variety of countries and regions in the authorisation process.

In Switzerland, the ICH Guidelines are deemed to be the documents representing the current state of science and technology once they have been approved by consensus within the ICH organisation. Swissmedic will apply the ICH E17 Guideline accordingly when it is published on the ICH website.

For more information, view the press release.

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Together with the coordination centres for clinical studies in Germany and Austria, we warmly invite you to the second tri-national congress on clinical trials.

Since the overwhelming response to the first such congress –  more than 550 participants attending the DACH Symposium of March 2016 held in Freiburg (D) – participants of this year’s event can again expect a richly diverse programme. As a special highlight, a live randomisation is planned at the close of the first day, intending to demonstrate in an amusing and expressive way how “flexible” study results can be.

The congress is aimed at all who are active in the field of clinical research, including professional groups working at trial sites as well as those in regular contact with trial site staff. Patients are welcome, too. Use this unique platform to exchange experiences within your field of expertise with hundreds of colleagues!

The 2nd DACH Symposium takes place on 11 and 12 June 2018 at the University of Zurich. The presentations and discussions at the three-nation congress are mainly held in German.

To learn more about the themes of the presentations and workshops that follow, which exhibitors are presenting their services and products onsite, and how to register, visit symposium-klinische-pruefungen.com.

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The Federal Office of Public Health (FOPH) is responsible for evaluating the efficacy of the Human Research Act (HRA). The results of this evaluation form the basis of any suggested improvements.

The FOPH conducts individual departmental research projects to monitor the impact of the law. As part of these departmental research efforts into human research, the FOPH commissions studies on specific issues. The findings form the basis of the evaluation of the law.

An overview of the projects so far can be found as of now under www.bag.admin.ch.

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