To date, those who develop and trial medicines have not been obliged to report the results to trial participants and the public, once a trial is completed. This lack of transparency will be a thing of the past, from the second half of 2020 onwards.

To this end, a “Roadmap Initiative to Good Lay Summary Practices” has been put in motion by the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the European Forum for Good Clinical Practice (EFGCP).

This Roadmap, which is being drafted through 2019 by representatives from academia, industry, and patient engagement, is tackling the following topics:

• the principles and processes of Lay Summary implementation beyond existing guidances;
• competencies required for developing and translating the lay summaries;
• dissemination, including technologies, of the summaries within and beyond the European Medicines’ Agency (EMA) portal;
• suitable processes and technology to reach patients, the health-interested public, and healthcare professionals;
• issues related to creating, translating, and funding the dissemination of the summaries, particularly for academia and small-to-medium enterprises; and
• matters of pertinence to paediatric clinical trials.  

The Clinical Trial Regulation EU 536/2014, which is set to come into effect in the second half of 2020, requires that a lay summary of trial results be disseminated in accessible language within 12 months after the end of the study and even earlier, within 6 months, for paediatric trials. Such feedback will give patients better, more understandable, and reliable access to the results of clinical trials. General awareness about this progress is low, not only among commercial and non-commercial sponsors (who will have to produce these lay summaries), but also among patients and patient organisations.

The EFPIA and EFGCP began preparing in 2015, in anticipation of these changes. The Roadmap underway builds on this foundation.

The SCTO is contributing to this process and will keep our readers informed, as this development is of importance to Switzerland.

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About 150 participants attended the event on 12 June 2019 in Geneva, organised in collaboration with the Geneva University Hospitals (HUG) and the University of Geneva. Local and international speakers shared their perspectives and developments on innovations in methodologies and outcome measurements, and their daily application in clinical research.

One of our key strategic goals at the SCTO is to promote value in clinical research. Clinical research must be of high impact and patient-relevant. Accordingly, we believe in bringing people together to learn, discuss, and compare practices, and to network.

The summary report and the presentations of the event are available under Symposium 2019.

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Since 2014, the ECRIN Data Centre Certification programme has been identifying non-commercial clinical trials units (CTUs) in Europe that have demonstrated safe, secure, compliant, and efficient management of clinical research data. The CTU Basel of our CTU Network is currently undergoing its audit to become the first Certified ECRIN Data Centre in Switzerland. 

So far, 11 centres across Europe have been certified. Subject to a successful audit, CTUs may be designated as Certified ECRIN Data Centres. Audits are based on standard requirements developed by ECRIN in three areas: IT, data management, and general.

Read more about ECRIN's Data Centre Certification.

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The European Clinical Research Infrastructure Network (ECRIN) and its French scientific partner F-CRIN organised a conference in Paris on 20 May 2019 to mark the International Clinical Trials Day (ICTD) 2019.

Besides ECRIN’s members and partners, scientists and policymakers from countries within and outside Europe were engaged in discussions on issues related to multinational clinical trials and the clinical research landscape in Europe. A specific focus was given to the challenges raised by patient stratification studies. Stratification is the grouping of study participants and results by a factor other than the treatment given, e.g. by gender, age, or other demographic factors.

For more information, visit www.ecrin.org.

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In April, our Regulatory Affairs Platform has launched issue 1 of Regulatory Affairs Watch. Subscribe to Regulatory Affairs Watch and learn more about the platform under SCTO Platforms.  

This email newsletter will deliver unique and credible information at regular intervals on regulatory topics pertinent to clinical research, existing and in development, in Switzerland and in other countries. Read in the first issue’s deep dive about the European General Data Protection Regulation (GDPR) and its interactions with clinical research.

The SCTO Platforms serve different clients with a range of needs. As centres of excellence, our platforms aim to be the first point of contact when questions arise regarding any topic related to clinical research. 

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With the Young Talents in Clinical Research programme, the Swiss Academy of Medical Sciences (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 research programme thereby contributes to implementing the Roadmap for developing the next generation of clinical researchers of the Federal Office of Public Health.

Grantees are expected to gain formal knowledge in clinical research by attending courses, e.g. of the CTU Network, which best fit their clinical specialty and career objectives.

The next submission deadline is 30 June 2019. Learn more about the participation requirements at www.sams.ch.

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For the fifth time, the Swiss National Science Foundation (SNSF) is launching a call for targeted funding of investigator-initiated clinical studies that are outside the industry focus. The SNSF recommends drawing up the study protocol with help from local Clinical Trial Units. 

The special programme for Investigator Initiated Clinical Trials (IICTs) of the Swiss National Science Foundation supports clinical studies on documented but underresearched medical needs. Though important for patients, these study topics remain outside the industry focus. The IICT programme does not provide support for non-randomised and uncontrolled studies.

Submission deadline is 1 November 2019. Find out more about the call at www.snf.ch.

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With its 3rd call for proposals, Personalized Health and Related Technologies (PHRT) invites clinical scientists who have access to an extensive sample cohort, to create an inter-institutional, interdisciplinary consortium to formulate a well-defined clinical question to request funding to generate matched genomic, transcriptomic, and proteomic data by the two PHRT platforms. Data integration, data analysis and data interpretation form an important part of the project, as well.

The submission deadline for the proposals of the 3rd call is 27 May 2019. The relevant documents describing the characteristics of this pioneering project and its requirements, well as detailed description of the general goals, scope, mode of operation, and project types of PHRT can be found at PHRT. 

Who is behind PHRT?
PHRT is a strategic focus area of the ETH Domain that fosters personalised health research in collaboration with hospitals and clinics, with CHF 50 million for 2017-2020. It offers technological know-how, expertise, and capacity from the ETH Domain institutions to medical and clinical partners by supporting collaborative interdisciplinary research.

What is personalised medicine?
The primary objective of personalised medicine is to recognise a human disease as a complex system and to achieve an integral and comprehensive understanding of this system at the molecular level, to select optimised treatment for each individual. The study of disease systems in this framework generally requires interdisciplinary, inter-institutional cooperation between basic scientists, data scientists, clinicians, and other disciplines.

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The Biobanking and BioMolecular resources Research Infrastructure (BBMRI), the European Research Infrastructure for Translational Medicine (EATRIS), and the European Clinical Research Infrastructure Network (ECRIN) signed an agreement in the last week of February in Brussels to build a long-term sustainable collaboration strategy.

The agreement lays the ground for facilitating user access to pan-European medical research infrastructures and supporting the development of tools, joint services, and common approaches on quality, standards, and advocacy. As a result, the agreement will empower the three parties to provide even better services to the biomedical community and to facilitate a more cost-effective research and development process.

The SCTO has been chosen by the State Secretariat for Education, Research and Innovation (SERI) to represent Switzerland in the ECRIN consortium. The ECRIN European Correspondent (EuCo) for Switzerland is based at the SCTO and coordinates fee-based services and support for scientific partner institutions nationally and internationally.

To read the press release about the agreement, visit eatris.eu.

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The buzz words “patient engagement” are heard more and more often in research settings. But how is patient engagement really carried out, well and meaningfully? At the SCTO, our strategic objectives include prioritising patient empowerment and involvement, which incorporates identifying useful tools to this end.

To round off the past year, Patient Focused Medicines Development (PFMD) handpicked the five best key articles to help readers embark on patient-centred projects. The articles are published as 2018’s essential reads in patient engagement. They showcase the maturation of patient engagement and a collaborative, international move underway – from talking about it, to actually doing it.

Questions probed include:

• What does patient-led research really look like?
• What essential role can patients take in developing clinical recommendations that are fit for purpose?
• Can it be demonstrated that patient engagement activities can reduce protocol amendments and improve the recruitment, adherence, and retention of participants?
• And how can involving patients in trial design and in defining outcomes improve the quality and relevance of research to patients in tandem with their participation in trials?
   

To explore the answers to these questions, browse the 2018 essential reads at PFMD.

PFMD is an open, independent global coalition of health stakeholders. Founded in 2015, it aims to transform the way in which we understand, engage, and partner with patients globally in the design and development of research and medicines, by focusing on unmet patient needs.

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The SCTO is included in an important listing. The newly updated International Compilation of Human Research Standards (2019 Edition), published by the U.S. Department of Health & Human Services (HHS), is a listing of more than 1,000 laws, regulations, and guidelines on the protection of human subjects (participants). It includes regional and international organisations from 131 countries.

The SCTO is proud to have been included for our Guidelines for Good Operational Practice (GGOP), representing a framework of common standards for professional and operational practice in clinical research. 

To access the compilation, visit the HHS.
Learn more about our GGOP under Publications.

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