Final Report Summary - ECRAN (European Communication on Research Awareness Needs) Executive Summary:The ECRAN - European Communication on Research Awareness Needs - project has been designed to develop a portfolio of open educational resources for the general population about the challenges raised by independent clinical research. It has been designed to support the strategy of the European Commission to fund independent (investigator-driven) multinational clinical trials. Independent clinical trials are considered of critical importance for improving the effectiveness, safety, and cost-effectiveness of health care. The target audiences of the ECRAN project were primarily patients and citizens, but also policymakers, healthcare professionals, researchers, and journalists. All the ECRAN materials have been developed to be simple, not technical, readable for all the targets, and easy to be used in the clinical practice. At the beginning of the ECRAN project an online survey on Learning Needs Assessment has been carried out on the public’s needs, the results have allowed to guide the development of ECRAN tools and materials. All the material and tools have been developed under Creative Common License and are freely available at the website of the project, http://www.ecranproject.eu. The materials and tools have been translated to cover 3/4 of the European population.The main results obtained by the ECRAN project are:- A website developed after a revision of the existing websites, in six European languages with some parts in 23 languages. All the tools developed are available on the website.- An animated film about clinical trials titled “Clinical research matters to you: do you want to know more?”. The film is available in 23 European languages.- A searchable online dynamic database where have been systematically collected, identified and catalogued communication materials and tools designed to convey the importance of clinical research to the public. The database is searchable in all 23 European languages. - Two serious/educational games to capture the interest of young European citizens and students. ECRAN Lab and ECRAN Maze are a cross platform games available in six European languages for iPad, Android Tablet and Windows 8. - A Media section dedicated to journalists to disseminate the contents of the ECRAN project uniformly across countries. - Interactive sibling websites of Testing Treatments Interactive in six languages. Testing Treatments is a book written for the public addressing many questions related to clinical research of interest for the ECRAN project. - A revision of existing Wikipedia pages related to clinical trials issues.Two months before the end of the project the Consortium has been organized a Celebrating event in Luxembourg. This was a joint initiative – ECRAN, ECRIN-ERIC (European Clinical Research Infrastructures Network), ICTD (International Clinical Trials’ Day) and CRP (Centre de recherché public) - to promote a transnational communication event on multinational clinical trials with the objective of facilitating better clinical research relevant to the needs of patients and highlight the important role of patients in clinical research. During the ECRAN project other dissemination activities have been: articles on magazines and newsletters, congresses at local and international level, learning activities, website links, blogs, twitters discussion lists, announce letter to ad hoc mailing lists of consumers and patients associations, distribution of the ECRAN brochure, an Open letter to all European Ministers of Education, European heads of schools, European teachers, and parents. Moreover networks such as ECRIN, Cochrane Consumers Network, PartecipaSalute and European AIDS Treatment Group widely disseminated the ECRAN project. The ECRAN project has achieved all its goals and now citizens, patients and all people involved in research have valuable tools and material to facilitate the understanding and the participation in clinical research. Project Context and Objectives:The European Commission funded in 2012 the two-years ECRAN project - European Communication on Research Awareness Needs - to improve the EU citizens’ knowledge about clinical research, and to support their participation in independent and multinational clinical trials. ECRAN’s principal aim was to inform citizens and patients, but also healthcare professionals, researchers, and journalists, about the importance of independent clinical trials driven by healthcare needs, the need for transparency and optimal use of data, and the importance or multinational cooperation, taking advantage of Europe’s population size and diversity.The ECRAN project has been designed to support the strategy of the European Commission to fund independent (investigator-driven) multinational clinical trials, as a major component of the FP7 cooperation health priority work programme. For the first time in 2011, 152M€ were allocated to 26 independent multinational clinical trials. Simultaneously, through its capacity programme, the Commission supported the development of ECRIN (www.ecrin.org) to provide an infrastructure for multinational clinical trials, initially through FP7 infrastructure funding for its preparatory phase (2008-2011), then through an integrating activity (2012-2015). Although the concept of randomised trials emerged from academic institutions, clinical trials are now central to the development of innovative health products seeking marketing authorisation from competent authorities. Industry-sponsored pre-licensing trials (commercial trials) account for more than 70% of all the clinical trials on medicinal products in Europe. However, a growing number of clinical trials are conducted independently of manufacturers, thanks to the development of appropriate infrastructures and to the availability of national public and charitable funding. Industry is not interested in investing in these trials, either because the product is already marketed, or because comparative data with alternative interventions is not currently required, or because the potential market is too narrow, or because of lack of other incentives. Until recently, multinational cooperation in independent clinical trials has been restricted by a lack of multinational funding. The FP7 initiative thus represents a major development in this field. Clinical trials refer to clinical research assessing the benefits and harms of interventions, such as medicinal products, medical devices, and therapeutic procedures such as surgery, physical and psychological therapies. Independent clinical trials are of critical importance for improving the effectiveness, safety, and cost-effectiveness of health care. They also help to establish the relative efficacy of interventions, and thus their position in the therapeutic armamentarium, and they foster affordability for the health services. Most drug and device clinical trials in Europe and elsewhere are sponsored by the health industry, working in close collaboration with academic investigators and clinicians. These trials are product-oriented, aimed at providing evidence for the benefits of a given health product (does this product merit a marketing authorization?). However, a very large number of clinical research questions are of little or no interest to commercial sponsors, yet they need to be addressed because of their importance in promoting the health of the public and improving diagnosis and therapy for large, medium-sized, and small patient groups. This large number of clinical research questions deals not only with drugs and devices, but also with new biomedical interventions, surgery, physiotherapy, psychology, rehabilitation, training, etc. Such healthcare-oriented research questions (what is the best therapeutic option for this disease, this patient or this group of patients?) are clearly critical for patients, healthcare professionals, healthcare systems, reimbursement policies and payers. They are usually addressed through the initiative of clinical investigators or patient groups. The need to support such independent (investigator-initiated and healthcare-driven) clinical research in addition to commercially-sponsored research has been recognized by the European Science Foundation (Investigator-Driven Clinical Trials 2009 Implementation of Clinical Research in Clinical Practice 2011), and the European Union.On the basis of these issues, the ECRAN project has been designed considering that:- Randomized clinical trials are a milestone of evidence-based medicine, but still citizens don’t have enough knowledge and awareness of the importance of this method.- Even if European Commission is allocating substantial funding to independent, investigator-driven clinical trials, the participation of citizens and patients in clinical research projects is still difficult.- A pan-European infrastructure for clinical trials (ECRIN) is available to design, coordinate, and facilitate inter-European clinical trialists, but without a shared package of information tools for general population and patients.The objective of the ECRAN project was to develop a portfolio of open educational resources to communicate key messages to general population - but also healthcare professionals, researchers, policymakers and journalists – about:- The importance of public understanding of need and basic principles of clinical trials, fostering active involvement of citizens/patients in trials and of their representatives in trial design;- The need for independent clinical trials, not only on drugs [!], driven by healthcare and patients needs, to optimise strategies, to support evidence-based clinical practice and to reduce healthcare inequalities.- The need for transparency and optimal use of data to allow their use in analysis and meta-analysis, but also to prevent bias in presenting and analysing results.- The need for multinational cooperation, taking advantage of Europe’s population size, diversity and medical expertise.Primary target of the ECRAN project: EU citizens, as tax payers, users of healthcare systems, and potential future patients, including school students, to raise awareness of clinical trials; patients and other participants in clinical trials; representatives of patient organizations. To ensure efficient dissemination, all the communication tools developed in the project have been translated and dubbed to reach at least 3/4 of the European citizens.Secondary target of the ECRAN project: Healthcare professionals; health and science policy makers, members of parliaments; members of research ethics committees; communicators, including journalists; and scientific community.In most of the European countries clinical trials are rarely the subject of debate among citizens or consumers or patients organizations. Still more rarely are the research priorities discussed a priori in an open debate between researchers, clinicians, and patients. The involvement of European citizens in supporting independent clinical trials as a method to lead health care assistance decisions varies among countries. Studies have shown that misconceptions about clinical trials are frequent, and that the level of participation in clinical trials is low. As a consequence, it is important to empower citizens and health consumers on the crucial aspects of clinical research, and increase their awareness of independent clinical trials. The ECRAN project aims to address this situation through a number of concerted activities.Project Results:The ECRAN project has achieved all its goals and now citizens, patients and all people involved in research have valuable tools and material to facilitate the understanding and the participation in clinical research. An overview of the ECRAN project is reported in the figure below. All the material and tools have been developed under Creative Common License and are freely available at the website of the project. The survey The first step of the ECRAN activities has been to undertake a Learning Needs Assessment, which was integrated into the task of collecting online materials related to understanding clinical trials. A survey of public users of health information to obtain information about the public’s need for information on clinical trials was carried out. The survey has been distributed using two main channels: (a) PatientView, an organization that keeps a database of patient groups via whom we were able to email to 20,000 English-speaking patient groups across Europe, and (b) NHS Choices, a website funded by the UK Department of Health, dedicated to informing the public on health issues. A total of 1852 completed the survey. The survey provided a glimpse into the lack of public understanding about how clinical trials are conducted. While the overall reason for conducting such trials may be understood, there is little further understanding of the process.The online dynamic database A searchable online dynamic database where have been systematically collect, identify and catalogue communication materials and tools that are designed to convey the importance of clinical research to the public. One hundred and eighty one unique online learning resources were identified through English-speaking patient groups, and an additional forty five unique resources through NHS Choices patient website, and seventy nine through ECRAN partner organisations. The database is searchable for resources in all 23 European Languages and it includes open educational resources, websites, videos, books, interactive applications, and others. The website The ECRAN website (http://ecranproject.eu) has been developed after a careful revision of the existing websites, in six languages, with some parts in 23 languages. The website is addressed to the general public, patients and participants in clinical trials as primary targets and to health professionals, policy makers, and communicators, as secondary targets. It provides plain language information on the project (key topics and messages of the project), access to all the communication material produced, updates and results of the ECRAN project. The style of communication taken into account the primary target, paying a constant attention to plain - matching easiness to precision, as necessary especially when referring to technical/scientific terms - and attractive - friendly and even with direct speech - style. The ECRAN website includes several sections:- Homepage it includes navigation tools and a presentation of the main sections, the links to ECRAN accounts on Twitter (https://twitter.com/EcranProject) and Facebook (https://www.facebook.com/ecran.project); in the footer there are the newsletter subscription, badges, survey and contacts.- “About clinical trials” is a core section of the website and it has been developed as an “on-line book” organized in two levels of titles with a clickable table of contents at the footer of each webpage. This solution offers the opportunity to easily add new contents during the whole life of the website. The following contents have been developed: information about clinical studies (e.g FAQs, tutorial, see WP6); glossaries in different languages selected using the information collected by means of the Inventory of resource and the websites analysis (an ECRAN glossary has not been developed firstly because many good quality glossaries are already available, but also for budget reasons); valuable materials for ECRAN key-messages communication to the public - “ECRAN film” - dubbed in 23 languages, complete sequence divided in the 8 modules-, “Inventory of resources” with a dedicated searchable online dynamic database, “Serious games”, “Testing Treatments Interactive” - Media center, section dedicated to journalists- ECARN Newsletter- Links to partners’ or international relevant initiatives on independent and multinational clinical research themes.- Downloadable badges to facilitate online dissemination.The final ECRAN website represents a distinct novelty in the European context, in terms of number of languages available and contents or objects.The animated film One of the most effective ways to convey information, in particular health information, is produce a film. For this reason the ECRAN Consortium decided to produce a film as a flagship of communicative tools, thanks also to the collaboration of RAI the Italian public television service and Studio Bruno Bozzetto. The text of the film was written on the basis of the key words of the project and through some interviews. This text has been translated in a story board, where images were associated with phrases. The story board has been discussed and reviewed among ECRAN partners several times and then the film was produced, first in Italian and in English. The film starts with the story of Scottish naval surgeon James Lind in his determined effort to treat scurvy, set up an experiment cheered today as one of the earliest clinical trial. The dubbing process produced 23 versions of the film. The dubbing process involved professional translators, but also colleagues from different countries and networks (as ECRIN and EATG) that review the text and the first version of the film. Now the film is available and free in 23 official European. Norwegian and Luxembourgish version are also available because two independent research groups decided to invest funds for dub the film in their language. It is possible to view the whole film (less than 5 minutes) but also have access to the 8 different modules regarding important aspects of clinical research: A clinical trial, Ethics committees, Randomization, Double blinding, Analysing the data, One trial is not enough... Outcomes have to be important to patients, Some pitfalls of trials.Serious games To capture the interest of young European citizens and students two serious/educational games have been developed. ECRAN Lab and ECRAN Maze are a cross platform games available in 6 languages for iPad, Android Tablet and Windows 8. According to a conventional classification ECRAN Lab - a game dealing with the 4 phases of clinical trials - belong to action games, which includes ability games, chase, fighting, while ECRAN Maze - a game aimed at improving knowledge and transferring information - belong to puzzle games which include quizzes and labyrinth and are particularly useful in transferring information and knowledge. Since April to June 2014, the ECRAN serious games and, more extensively, the ECRAN project as a whole, were presented to the students of a secondary school in Milan. This activity represented a good opportunity to test communication materials on a sample, even of limited size, of young European citizens, one of the main target of the ECRAN project.Media Section A section dedicated to journalists to disseminate the contents of the ECRAN project uniformly across countries This section, addressed to journalists/peer-to-peer, has been conceived as a professional toolkit to introduce different aspects of knowledge and awareness about clinical trials (methodological aspects, how to get reliable information, how to report results, how to explain technical terms using a plain language, …) and has been written by a group of expert professionals, able to communicate in a shared language. The organization of the media centre section in ECRAN website has taken as model the website dedicated to the media journalists. More specifically:- A professional guide (e.g. "Guide to the critical interpretation of clinical trials") suited for journalists and showing all the tricks useful for the job.- A list of FAQs for professional.- A quick presentation of ECRAN project.- Several collections of valuable materials.- The ECRAN newsletter. Sibling Websites An interactive sibling web page under the title Testing Treatments. Testing Treatments is a book written for the public addressing many questions related to clinical research. A first edition was published by the British Library in 2006, and a second edition by Pinter and Martin in 2011. The book has been a great success, and has been translated into several languages. Preparation of the books was done as one element of the work of the James Lind Initiative, a programme of work coordinated by Iain Chalmers, an ECRAN partner, and funded by the English National Institute for Health Research. The English texts of both editions of the book are available for free download from Testing Treatments interactive (TTi) English – and translations are available in sibling TTi websites in other languages. All of the TTi websites also contain audio materials, videos, cartoons and other materials to enhance general knowledge of fair tests of treatments. It has to be highlighted that ECRAN website includes a direct link to each TTi sibling site available in a European language (English, Croatian, French, German, Italian, Norwegian, Polish, Portuguese, Spanish) and another link to TTi homepage (http://www.testingtreatments.org/) where users can search all the available translations. Wikipedia The Wikipedia is far larger than any printed encyclopaedia, thus it is important reviewing pages related to the ECRAN keywords in terms of completeness, reliability, and readability of information reported. In the framework of the ECRAN project the revision of the existing Wikipedia pages in English, German, French, Italian, and Spanish has been performed. The revision of the pages language by language suggested that most key words are not covered by many languages and the availability of information on clinical trials is not uniform among the different languages considered. A new Wikipedia page on “independent clinical trials” covering the above topics has been setup in English and translated in Italian, French, Spanish, and German. ECRAN Celebrating event Last May a Celebrating event in Luxembourg - where the ECRAN project and its tools and materials were officially presented – has been organized. This was a joint initiative – ECRAN, ECRIN-ERIC (European Clinical Research Infrastructures Network), ICTD (International Clinical Trials’ Day) and CRP (Centre de recherché public) - to promote a transnational communication event on multinational clinical trials with the objective of facilitating better clinical research relevant to the needs of patients and highlight the important role of patients in clinical research. In order to facilitate the participation of citizens and patients associations a bursary was available to cover travel expenses. A total of 36 bursaries has been paid.Finally, the last activity promoted by ECRAN partner is an open letter (petition) to all European Ministers of Education, European heads of schools, European teachers, and parents. The letter regards the introduction to clinical research as part of the school education for all European school pupils for three consecutive years around the ages of 14, 15, and 16 years, see at http://www.ecranproject.eu/en/node/319.Potential Impact:The aim of the ECRAN project was to develop materials and tools on independent clinical trial reaching most of the European citizens with a core information in different European languages.Throughout the project there have been many opportunities to disseminate its contents and the materials. The interest on the issues considered by the project is very large at different levels: from the clinicians and the researchers directly involved in clinical research, citizens and to consumers and patients associations, to journalists or representatives of Ethics Committee. The ECRAN activities have been promoted through:- Congresses and meetings at local and international level, learning activities.- Articles on magazines and newsletters.- Website links, Blogs, twitters discussion lists.- Letter to ad hoc mailing lists of consumers and patients associations, distribution of the ECRAN brochure.- Organized networks such as European Clinical Research Infrastructures Network (ECRIN), Cochrane Consumers Network, PartecipaSalute and European AIDS Treatment Group (EATG). - Network of clinicians such as ECRIN, Ethics Committees, clinical researchers groups has been invited to circulated the film, or to link of the film. The collaboration of some of the ECRAN partners or Advisory Board members has been requested as opinion leaders in networks of clinical researchers, or Ethics committees where they are involved.- Journalists and media have been also involved in dissemination process.- A Press release has been launched in January 2013. - An Open letter (petition) to all European Ministers of Education, European heads of schools, European teachers, and parents http://www.ecranproject.eu/en/node/319. - The Celebrating event in Luxembourg where ECRAN project was officially presented to scientific community, citizens and patients associations, and journalists.Moreover a scientific article titled “An European multi-language initiative to make aware general population on independent clinical research: the ECRAN project” to convey information to the scientific community is ready to be submitted to a peer review journal.This interest is witnessed by different articles published on magazines and newsletter, and by contributions on the different health information websites of associations of citizens and patients, by congress and meetings were ECRAN tools have been presented. At the level of clinicians and researchers ECRAN tools have been reported at conferences and congresses. Also in some large public events on science, such as Dusseldorf (research Night) or Genoa (Festival of Science) open meeting, the ECRAN tools has been disseminated. The brochure on the project has also been circulating in different countries.A summary of the dissemination activities is reported in the table below: NUMBER OF ACTIVITIES BY TARGET TOTAL NUMBER Scientific Community^ Lay people^ Several targetsCongresses, meetings, training courses 35 (n=25) (n=13) Social Media 14 (n=14)Radio, talk show 4 Websites 38 articles collected and reported in the Template A2 Links 1120 links from 85 sites Articles published in the popular press 23 (n=23)Mailing lists, correspondences 7 (n=4) (n=4)Brochures 1.200 in English2.000 in Italian200 in German 200 in Spanish200 in French200 in Polish ^ Some activities had both scientific community and lay people as targets.Regarding the ECRAN website, the last 8 months (January 2014-August 2014) of the project registered the audience reported in the figure below. The top languages used were: English, Polish, Italian, German, France, Spanish, and the top 10 countries visiting the ECRAN website were: Italy, Poland, German, UK, France, United States, Spain, Belgium, Switzerland, and India.Regarding the animated film, in the figure below is reported the number of views by languages for the period 2013 June to 2104 August: 13524 views on Vimeo. The film is available also through You Tube. During the ECRAN project tools and materials have been developed and have been widely disseminated. However the real impact of this dissemination process would need an hoc research activity. Considering the potential impact of the ECRAN project, together with the discussions that came out during the Celebrating event at the end of the project, some implications can be underline:- Independent clinical research – if easily presented as by ECRAN tools – is an important key issue for lay people and their representatives, such as citizens’ and patients’ associations- Clinical trial is a milestone of clinical research but still several aspects need to be discussed and shared among the different stakeholders- The knowledge on clinical research among the general population needs to be increased- European young people should be reach with ad hoc tools such as the ECRAN serious games to be involved in the health literacy process- The translation and dubbing process of most of the ECRAN tools and materials developed supports the equity of access to the information regarding independent clinical research - All stakeholders agreed on the importance to have a multidisciplinary discussion on clinical trials with the aims to increase the quality of clinical research, the dissemination of results, and the participation of patients- Conflict of interest, transparency, and information are considered key issues to promote clinical research corresponding to the needs of patients and society and to obtain results useful to really change the clinical course of illnessDuring the work conducted within the project, it has become increasingly clear that results obtained with ECRAN could contribute to the development of high quality clinical research, in particular with joint initiatives with clinical groups, such as ECRIN-ERIC, the European Clinical Research Infrastructures Network.Therefore, there were strong support among all participants of the ECRAN event to try to raise centralised funds for making an organisation like ECRAN viable for the future with its multi-stakeholder representation and a balanced view on evidence-based medicine and evidence-based clinical practise.List of Websites:www.ecranproject.euPaola Mosconi, Biol Sci DPublic HealthIRCCS-Mario Negri InstituteVia La Masa 19 20156 Milano Italypaola.mosconi@marionegri.it Documents connexes final1-ecran-final-report-24-months.pdf
