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From the Director General

Welcome to ECRIN's first newsletter. Each issue will bring you updates on ECRIN-supported clinical trials, collaborative projects, events and publications, and additional trial support activities - from tools development to data centre certification and more. We hope you enjoy hearing from us!

Sincerely,
Jacques Demotes
Director General, ECRIN

Spotlight

International Clinical Trials Day (ICTD) 2016

ECRIN held a meeting on "Clinical trials in the era of personalised medicine" on May 20th, 2016 in honour of International Clinical Trials Day (ICTD).

The event, which brought together around 150 participants, was organised in collaboration with ECRIN's Czech national scientific partner (CZECRIN), and held at the Senate of the Parliament in Prague, Czech Republic. 

The ICTD conference first addressed the unclear definition of personalised medicine, a phrase used in three distinct situations: individualised medicine, targeted therapy and stratified medicine.

The personalised medicine approach refers to healthcare strategies where the treatment option depends on decision trees involving identification of genomic biomarkers, epigenetic factors, phenotypic characteristics, and psychological, social and environmental determinants. Personalised medicine however appears as a quantitative rather than qualitative change in medical practice: treatment decision is based on a more complex and comprehensive diagnostic procedure, more closely related to the molecular and cellular mechanisms underpinning the disease.
 
Such increased complexity is expected to result in improved accuracy of treatment, enhancing safety and/or efficacy. However, targeting a protein or signaling pathway may not necessarily lead to the expected therapeutic action. Treatments still have to be tested in interventional trials to demonstrate their superiority in terms of efficacy and safety when compared to the standard of care. This raises many issues regarding the sample size, multiple analyses and trial design.
 
Access to patients and to medical expertise is anyway critical to provide evidence for the efficacy and safety such healthcare strategies. Therefore, international cooperation, and access to multinational funding sources is crucial for the development of this therapeutic approach.

Read the full text here

Clinical Trial Update

The FAIR-PARK II trial (Conservative Iron Chelation as a Disease-Modifying Strategy in Parkinson's Disease, PD) has held site initiation visits at all participating sites in France (sponsor country). The first patient was enrolled in February 2016. 

Following regulatory and ethical approval in the additional participating countries (UK, Germany, Austria, Spain, Portugal, the Netherlands, Czech Republic), site initiation visits are expected to be held at all sites and initiation of patient recruitment in September 2016 in these countries.

Funded by Horizon 2020, FAIR-PARK II is coordinated by France (CHRU Lille, Prof. Devos); ECRIN provides operational services to the sponsor for the conduct of the multinational trial (regulatory and ethical submissions, monitoring and local pharmacovigilance) upon delegation.
 FAIR-PARK II has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement no. 633190.

For more information on ECRIN-supported trials (non-exhaustive list), click here

CORBEL User Survey


ECRIN has prepared a short survey for medical research communities on their use of research infrastructures (RIs) in Europe. 

The survey will make it possible to capture the needs of these communities in terms of tools and services, and to drive the development of RIs to facilitate work and foster collaboration.

Please answer the survey before 31 July 2016.

This survey has been developed as part of the CORBEL project. CORBEL will establish a framework for the collaborative and sustainable development of shared services between the European Strategy Forum on Research Infrastructures (ESFRI) Biological & Medical Research Infrastructures (BMS RIs). (ECRIN is one of 12 such organisations.) CORBEL is funded by the European Union Horizon 2020 research and innovation programme (grant agreement no. 654248).

The results of the survey will be discussed at a CORBEL meeting, hosted by ECRIN in Paris on 12 October 2016.

Upcoming Event

CORBEL Meeting on Patient-Level Data-Sharing

ECRIN will organise the second workshop of the patient-level data task force in Milan from 6 to 7 October 2016. The task force aims to develop a common framework to provide access to anonymised, patient-level clinical trial data for re-analysis / meta-analysis in Europe. This initiative is in line with a recent editorial from the International Committee of Medical Journal Editors requesting a data-sharing plan as part of the study protocol (N Engl J Med 2016; 374:384-386).

Data Centre Certification Call

ECRIN is now accepting applications from CTUs within its Member Countries (France, Germany, Hungary, Italy, Norway, Portugal, Spain) to become certified as ECRIN data centres.

For more information and to access the application form, click here

Publication

ECRIN has contributed to a new scientific publication entitled "Evidence-based clinical practice: Overview of threats to the validity of evidence and how to minimise them". 

The article is one of the outcomes of the ECRIN Integrating Activity (ECRIN-IA) methodology workshop held in Milan in 2013. Other guidance papers on methodology will follow soon.

ABOUT ECRIN

The European Clinical Research Infrastructure Network (ECRIN) is a non-profit intergovernmental organisation that supports multinational clinical trials in Europe.

With a focus on investigator-led studies, we provide diverse services and tools for the preparation, validation and implementation of trials. We also participate in projects aiming to facilitate and enhance collaboration on clinical research in Europe and globally. 
EUCOS & NATIONAL SCIENTIFIC PARTNERS

Based in Paris, ECRIN has European Correspondents (EuCos) in its nine Member and Observer Countries.

Experts in clinical research, EuCos oversee the trial portfolio in-country in close coordination with ECRIN's national scientific partners (networks of clinical trial units, or CTUs):
FUNDING CALLS

ECRIN can support investigators to develop EU funding applications for multinational clinical trials, and then provide trial management services. 

ECRIN is now supporting applications for select calls from the Horizon 2020 'Health, Demographic Change and Well-being' work programme 2016-2017, including:
ECRIN QUICK LINKS
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