Direct download as pdf
- ECRIN Calendar
- Activities of ECRIN working parties
- ECRIN International Trials' Day celebrations
- ICTD celebrations around the world
- Update of the CONSORT Statement
- LEAN Trial - ECRIN pilot project
- 6S Trial - ECRIN pilot project
- ECRIN in the news
- ECRIN people
- Where is the top of the health care evidence hierarchy?
ECRIN Newsletter April 2010
Dear ECRIN NEWS readers,
Welcome to the April 2010 issue of ECRIN NEWS. In this issue we feature the ECRIN annual meeting, International Clinical Trials’ Day celebrations in Stockholm on May 20th which is open to everyone, we bring you up- to-date on the activities and developments in the ECRIN working parties, we bring you news of ECRIN’s publications, and more.
We warmly welcome the Polish clinical research network as a new ECRIN partner. Slawomir Majewski is the Polish National Coordinator and Cesary Szmigielski is the member of the ECRIN Network Committee. We also welcome Natascha Trzepizur as a new ECRIN European Correspondent in Austria. We send thanks and best wishes to Ravy Dolique Hor and Roxane Brachet who moved to new positions earlier this year, and to Diana Winter who will remain involved with the working party on education.
Best wishes, The Editorial Team
ECRIN Calendar
ECRIN WP8 Quality Assurance meeting
April 8th 2010, Barcelona.
ECRIN WP8 Pharmacovigilance Group meeting
April 9th 2010, Barcelona.
Newsletter, Issue 7 ISSN 1903-1521
Website Core Group training
April 13th 2010, Paris.
ECRIN European Correspondents meeting
April 29th 2010, Paris.
Network Committee and European Correspondents meeting
April 30th 2010, 09h00-12h00, Paris.
ECRIN WP3 Financial Plan Group meeting
April 30th 2010, 12h00-16h30, Paris.
ECRIN Network Committee meeting
May 20th 2010, 11h00-13h00, Stockholm.
ECRIN celebration of International Clinical Trials’ Day
May 20th 2010, 13h00 to15h50, Berns Salonger, Stockholm.
Speakers include Pierre Lafolie, Eva Nilsson Bågenholm, Cor Oosterwijk, and David Moher. Everyone is welcome.
Swedish celebration of International Clinical Trials’ Day
May 20th 2010, 11h00-18h00, Stockholm. All day, outdoor event in Kungsträdgården. Everyone is welcome and we hope you help us break a world record.
ECRIN Annual meeting
May 21st 2010, 08h00-16h30, Stockholm. Plenary sessions and break-out sessions.
ECRIN Users’ meeting
June 21st 2010, Brussels.
Activities of ECRIN working parties
WP2 Legal status and governance is finalising the details of the ECRIN-ERIC statutes. The statutes will be presented to the pertinent Ministries in the different ECRIN countries together with the ECRIN business plan. Also, the group is embarking on writing the “Rules of internal procedures”. This document will describe in depth how the ECRIN-ERIC Members and bodies will interact; input and comments on these documents will be sought from stakeholders in ECRIN.
WP3 Financial plan has completed a survey of ECRIN users in all ECRIN countries. The results and impact of this survey are being discussed and the group will provide feedback to be used in the ECRIN business plan and the ‘Technical annex’ of the business plan.
WP4 Good manufacturing practice (GMP) facilities is circulating a questionnaire to be completed by biopharmaceutical manufactures. The purpose is to get an overview of the existing resources in terms of GMP facilities for biopharmaceuticals and biotherapies.
WP5 Education is organising the European Correspondents’ Summer School, on the 13th to 15th September in Valsesia, Italy. The agenda is being finalised. There will be further work on the ECRIN campus electronic learning tool, specifically on the section on ‘Competent authority interaction’ and a new section on Ethics committees.
WP 7 Capacity building has visited representatives of clinical research networks in Portugal, Hungary, and Poland. Following these meetings ‘Capacity Building reports’ are circulated to the ECRIN Network Committee. Poland will join ECRIN as a new partner. A meeting was held on April 12th with representatives of the POLCRIN network and with the ECRIN working parties WP5 Education and WP6 Extension. Portugal is very interested in joining ECRIN.
WP 8 Quality Assurance is currently developing ‘Instructions’ which describe how ECRIN works internally and ‘Policies’ which describe what ECRIN requires from the institution providing the services. WP8 has recently approved the instruction documents on ‘The overall role, responsibilities and communication of European Correspondents in clinical trials within ECRIN’ and ‘Management of the e-learning tool ECRIN campus’ and the policy document on ‘Support given by ECRIN partners for multinational clinical trials with regard to interaction with Competent Authorities and Ethics committees’. The group met face-to-face on the 8th April in Barcelona and discussed the status and the future strategy of the group.
WP 8 Pharmacovigilance met face-to-face in Barcelona on April 9th. Topics included finalising the policy document, discussing the creation of ECRIN central safety desks, and benchmarking activities. Invited speakers, Caridad Pontes from Spain (commercial sponsor) and Nathalie Dubois of EORTC (academic sponsor) presented their viewpoints and experiences of pharmacovigilance in Europe and helped the group to envision the role of ECRIN in multinational pharmacovigilance.
WP8 Ethics group and WP8 Regulation group are in the process of submitting further articles to peer-reviewed journals. The Regulation group sent a response to the public consultation paper on the functioning of the Directive 2001/20/EC. The resulting report from the European Commission is available on the ECRIN website
WP8 Monitoring group has finalised the self assessment sheet aimed at clinical trial units and research centres which perform monitoring services for clinical trials. The policy document ‘Support given by ECRIN partners for monitoring clinical trials’ is in the final state of discussion.
WP9 Communication has uploaded the programme, posters and podcast for this year’s International Clinical Trials’ Day celebrations on the ECRIN website and have sent out postal invitations to patient organisations and disease oriented networks. The Website core group has launched the updated ECRIN website. Usability tests have provided useful feedback. The group was trained on how to edit and upload in the website and then trained the European Correspondents to manage the internal section. Usability tests have provided useful feedback. The group was trained on how to edit and upload in the website and then trained the European Correspondents to manage the internal section.
WP10 Data centres met face-to-face in March in Brussels to discuss data management and information technology requirements for certification of ECRIN data centres. The document ‘Requirements for certification of ECRIN data centres’ is under revision.
WP11 Pilot projects the 6S trial and LEAN trial have been accepted by the ECRIN Scientific Board as ECRIN pilot projects. The 6S project is a phase IV clinical trial in people with severe sepsis and has randomised 50 participants. The LEAN trial is a phase II trial that will involve participants with non-alcoholic steatohepatitis. In total, there have been 8 projects judged as eligible for ECRIN support and currently 5 projects are in the acceptance phase.
ECRIN International Clinical Trials’ Day celebrations
This year ECRIN will celebrate the International Clinical Trials’ Day (ICTD) in style, at Berns Salonger in Stockholm. The programme of talks and discussion will be held in the Kammarsalen conference room in Berns Salonger in Berzeli Park. This venue has been a Stockholm landmark since 1863.
All are invited to this event!
13.00-13.05 Christian Gluud, ECRIN Network Committee, DCRIN, and the Copenhagen Trial Unit, Denmark.
Welcome - why are we here?
13.05-13.10 Pierre Lafolie, ECRIN Network Committee, SweCRIN, and Karolinska Trial Alliance, Stockholm, Sweden.
Welcome to Stockholm - Public celebrations of ICTD: ‘Research and Health’.
13.10-14.00 Eva Nilsson Bågenholm, President Swedish Medical Association, Stockholm, Sweden.
The Declaration of Helsinki 2008 and ongoing work regarding the use of placebo in trials.
14.00-14.30 Cor Oosterwijk, Secretary General EGAN, European Genetic Alliances’ Network, Soest, The Netherlands.
Will patient involvement change the clinical trial landscape? Findings from the European Patient-Partner project.
14.30-15.20 David Moher, Director of the University of Ottawa, Canada.
Lots of money spent, lots of trials conducted and analyzed: how far are we with reporting them?
15.20-15.45 Panel discussion.
ICTD celebrations around the world
Italy The Mario Negri Institute in Milan will host an event to celebrate the International Clinical Trials‘ Day (ICTD) 2010. The event will take place on the 19th of May. The theme is “Which research for which health? The centrality of citizens and patients in the debate on the social dimension of health”. http://www.marionegri.it/mn/it/docs/aggiorname nto/news/Clinical_day_2010.pdf
Sweden On the 20th of May there will be an all-day outdoor fair in Kungsträdgården, Stockholm. The event is open to everyone, so come and enjoy the entertainment, debates, lectures, and the grand finale: a toga party! ECRIN will have a tent for you to visit during the day.
11h15-12h00 Political hearing
12h00-12h30 Entertainment
12h30-16h40 Debates and lectures (topics: cardiology, women’s health, clinical research and society, transparency)
16h40-19h30 Alzheimer’s disease theme
17h30-18h00 Toga party world record for Alzheimer’s disease.
United Kingdom Huddersfield and Calderdale Royal Hospitals are hosting celebrations of the ICTD on May 20th. The initiative highlights some of the clinical trials currently underway, particularly in the areas of oncology, stroke, haematology, and obstetrics and gynaecology. Specialised research nurses will be available at the stands.
Update of the CONSORT statement
Schulz KF, and co-workers. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. Trials 2010 Mar 24;11(1):32.
The CONSORT (Consolidated Standards of Reporting Trials) statement is a guideline for the reporting of clinical trials. The CONSORT Statement includes a checklist and a flow chart, to help authors communicate their clinical trial as clearly as possible, with all the pertinent details.
It was originally published in 1996 and first updated in 2001. With new methodological evidence and accumulating experience of performing and reporting trials, 2010 sees the second update of the CONSORT Statement. Developing and updating the CONSORT Statement follows an evidence-based approach.
A key part of performing clinical research is reporting it. “To assess a trial accurately, readers of a published report need complete, clear, and transparent information on its methodology and findings.” David Moher, author and member of the CONSORT group, will talk about reporting of clinical trials in Stockholm on May 20th for the 2010 International Clinical Trials' Day celebrations.
Changes to the CONSORT Statement 2010 include: requirement for more explicit descriptions of how the trial was performed; clearer description of, and reasons for, any changes made to the methods or to the outcome measures during the trial.
LEAN trial – ECRIN pilot project
Current treatment options for patients with non-alcoholic steatohepatitis (NASH) are limited in efficacy, so there is a need to develop more effective options.
The LEAN (Liraglutide efficacy and action in non-alcoholic steatohepatitis) trial will study the effects of the drug Liraglutide, a long- acting glucagon-like peptide-1 agonist, in overweight patients with NASH, in the presence or absence of type II diabetes.
The primary objective of the LEAN trial is to investigate whether 48 weeks treatment with once-daily injections of Liraglutide results in an improvement in liver histology. The secondary objectives are to assess the clinical safety profile of Liraglutide and to investigate whether Liraglutide improves non-invasive markers of liver/metabolic disease and quality of life in patients with NASH.
LEAN is a multinational, multi-centre trial with centres including Birmingham, in the UK and Bochum, in Germany. The trial is an academic collaboration between experts in the field of diabetes and liver medicine. LEAN is supported by the global charity, The Wellcome Trust.
LEAN is registered with ‘Current Controlled Trials’ ISRCTN number 85774727 http://www.controlled- trials.com/ISRCTN85774727/
6S trial – ECRIN pilot project
The 6S trial - Scandinavian starch for severe sepsis/septic shock trial - studies the effects of one type of starch solution (hydroxyethyl starch) compared with a balanced crystalloid solution, on mortality and kidney failure in patients with severe sepsis. ClinicalTrials.gov identifier NCT00962156.
In January 2010 the 6S trial started randomising trial participants and to date has randomised 50 participants in 7 centres in Denmark. By May, Finnish and Icelandic centres will also be screening and randomising participants. There is now confirmed approval from pertinent ethics committees in Norway, so after the summer, 3 Norwegian centres will be able to start recruiting participants as well. The 6S sponsor-investigator or project manager will visit each randomising centre during May and June 2010.
ECRIN in the news
Stankovski L, Kubiak C, Demotes-Mainard J. ECRIN: making multinational clinical trials in Europe easier. EJHP Practice. 2009;vol.15 (6):61-2.
This article discusses the need for EU-wide infrastructure networks to overcome the obstacles of multinational clinical research. ECRIN’s three-stage development, European extension, and partnering with worldwide clinical research infrastructures is presented. The role of the national ECRIN European Correspondents in providing services and consultancy to sponsors and investigators in clinical research, acting as the interface between the national clinical research networks and the ECRIN coordination, is described.
To date, ECRIN has had a considerable impact on structuring of clinical research in Europe through contributions to the Impact on Clinical Research of European Legislation (ICREL) project, consultation on the European Directive 2001/20/EC, and participation in education policies through the Innovative Medicines Initiative.
The article concludes that ECRIN will not only benefit the academic scientific community but also small and medium sized enterprises and pharmaceutical companies, therefore increasing the competitiveness and attractiveness of Europe for clinical research activities.
Frewer LJ, Coles D, Champion K, Demotes-Mainard J, Goetbuget N, Ihrig K, Klingmann I, Kubiak C, Lejeune SA, McDonald F, Apperley J. Has the European Clinical Trials Directive been a success? BMJ 2010;340:c1862.
This editorial expresses concerns of the impact of the European Clinical Trials Directive (EU 2001/20/EC) and sets out possible solutions. There is evidence that the directive has had a negative effect on clinical research. The editorial describes the work done and the solutions proposed by 9 organisations (including ECRIN) to the most important obstacles to clinical trials in Europe.
Recommendations include:
- Require only one clinical trials authorisation (CTA) for all multinational clinical trials
- Simplify and harmonise the procedures for clinical trial approval and safety reporting
- Better define and harmonise the roles and review processes of ethics committees and competent authorities
- Adopt a risk based approach—adapt the regulatory requirements to consider the risk associated with the trial with regard to safety reporting, data monitoring, insurance, application dossiers, substantial amendments
- Allow co-sponsorship in the case of multinational trials
- Better define terms and concepts
- Increase public financial support for investigator-driven clinical trials
- Harmonise insurance.
The directive will be reviewed in October 2010; the recommendations of these 9 organisations will contribute to this review.
http://www.bmj.com/cgi/content/extract/340/apr09_1/c1862
ECRIN People
As my degree is in Information Technologies, my activities are usually behind the scenes. During my studies at the Institute for Chemical Oncology at University Hospital Düsseldorf,
Germany I learned to combine computer systems and medicine. For one project I programmed a medical database with an online gateway for faster result transfer. In the beginning of 2004 I started work at Coordination Centre for Clinical Trials of the Medical Faculty of the Heinrich-Heine University Düsseldorf. Since 2007 I have been the head of the workgroup in data management. The Coordination Centre for Clinical Trials Düsseldorf operates a GCP-compliant remote data entry and adverse event reporting system for which I am the system and database administrator.
Data management not only means receiving data with case report forms (CRFs), it is also the process of developing electronic CRFs, programming databases and plausibility checks. I am responsible for the coordination of these processes with principal investigators and project managers. Additionally, from 2006 to 2009 I was director of Penguin Trials Ltd. & Co KG who controlled PhOSCo (Pharma Open Source Community).
My first contact with ECRIN was during a brainstorming session on the ECRIN Website in July 2005. After this I started programming on static public internet sites. As the need for dynamic content grew I am now administrator of one of the most powerful open source content management systems.
Gerd Felder
Where is the top of the health care evidence hierarchy?
Ioannidis JPA. Integration of evidence from multiple meta-analyses: a primer on umbrella reviews, treatment networks and multiple treatments meta-analyses. CMAJ. 2009;vol.181(8):488-93.
Randomised clinical trials and systematic reviews with meta-analyses of such trials are usually at the very top of the evidence hierarchy. John PA Ioannidis discusses an additional layer. Even a perfectly conducted meta-analysis with perfect data on one treatment comparison may offer a short- sighted view of the evidence. Usually there are many treatments and many outcomes to consider. Ioannidis suggests one should also consider alternative treatments and what their effects are on beneficial and harmful outcomes. If the trial results are compatible, the overall picture can help one to better appreciate the relative merits of all available interventions.
There are two main methods used to integrate evidence across multiple meta-analyses: umbrella reviews and multiple treatments meta-analysis. An umbrella review can provide a wider picture on many treatments. A limitation is that they rely on the availability, comprehensiveness, and quality of pre- existing reviews. The integration is also limited by different eligibility criteria, different evaluation methods, etc between the reviews.
A multiple treatments meta-analysis groups all the treatment comparisons performed for a specific condition. A limitation is that this analysis makes the assumption that all of the data can be analysed together.
The quarterly ECRIN NEWS is written and edited by the ECRIN staff in the Copenhagen Trial Unit, Denmark, the UK Cancer Research Network, UK, and in the Medical University of Vienna, Austria. It is published in electronic form on the ECRIN website www.ecrin.org. Editorial staff are Christian Gluud, Chief Editor; Helen Howard, Editor; Johannes Pleiner, Editor; Diana Winter, Editor; Kate Whitfield, Managing Editor. Postal address: Copenhagen Trial Unit, Centre for Clinical Intervention Research, Dept 3344, Blegdamsvej 9, DK 2100, Copenhagen, Denmark. Tel. +45 3545 7169 or 68, Fax. +45 3545 7101, E-mail kate.whitfield@ctu.rh.dk
