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Implementation of Medical Research in Clinical Practice

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Implementation of Medical Research in Clinical Practice FORWARD LOOK Implementation of Medical Research in Clinical Practice www.esf.org European Science Foundation European Medical Research Councils The European Science Foundation (ESF) is an independ- The European Medical Research Councils (EMRC) is the ent, non-governmental organisation, the members of membership organisation for all the Medical Research which are 78 national funding agencies, research per- Councils in Europe under the ESF. forming agencies, academies and learned societies from The mission of EMRC is to promote innovative medical 30 countries. research and its clinical application towards improved The strength of ESF lies in its influential membership human health. EMRC offers authoritative strategic advice and in its ability to bring together the different domains for policy making, research management, ethics and of European science in order to meet the challenges of better health services. In its activities, EMRC serves as the future. a voice of its Member Organisations and the European Since its establishment in 1974, ESF, which has its scientific community through its science policy. headquarters in Strasbourg with offices in Brussels and EMRC has an important role in the future development of Ostend, has assembled a host of organisations that span medical research in Europe and it invites the European all disciplines of science, to create a common platform Commission, the European Research Council, learned for cross-border cooperation in Europe. societies, universities and academic medical centres ESF is dedicated to promoting collaboration in scientific for debate and action to bring its recommendations to research, funding of research and science policy across fruition. Europe. Through its activities and instruments ESF has www.esf.org/emrc made major contributions to science in a global context. ESF covers the following scientific domains: • Humanities • Life, Earth and Environmental Sciences Forward Looks • Medical Sciences The flagship activity of ESF’s strategic arm, Forward • Physical and Engineering Sciences Looks enables Europe’s scientific community, in interac- • Social Sciences tion with policy-makers, to develop medium- to long-term • Marine Sciences views and analyses of future research developments • Materials Science and Engineering with the aim of defining research agendas at national • Nuclear Physics and European levels. Forward Looks are driven by ESF’s • Polar Sciences Member Organisations and, by extension, the European • Radio Astronomy research community. Quality assurance mechanisms, • Space Sciences based on peer review where appropriate, are applied at www.esf.org every stage of the development and delivery of a Forward Look to ensure its quality and impact. www.esf.org/flooks Chair and Co-Chairs: Professor Liselotte Højgaard, EMRC Chair, Denmark Professor Stig Slørdahl, RCN, Norway Dr Edvard Beem, ZonMw, The Netherlands ESF Chief Executive: Professor Marja Makarow, ESF, France EMRC Chair: Professor Liselotte Højgaard, EMRC Chair, Denmark Coordination: Dr Stephane Berghmans, ESF, France Dr Kirsten Steinhausen, ESF, France Science writer: Mr Simon Hadlington, United Kingdom Support: Mrs Janet Latzel, ESF, France Cover pictures: © iStockphoto; GettyImages Dr Maria Manuela Nogueira, ESF, France “I have been impressed with the urgency of doing. Knowing is not enough; we must apply. Being willing is not enough; we must do!” Leonardo da Vinci (1452-1519) and Johann Wolfgang von Goethe (1749-1832) Contents Executive Summary 3 Foreword 5 Acknowledgements 6 1. Introduction 7 2. Knowledge Generation 12 3. Knowledge Interpretation 22 4. Knowledge Implementation in Clinical Practice 25 5. Perspectives from General Practice 33 6. Patient and Public Involvement in Research 37 7. Diversity Across Europe 40 8. Recommendations 41 9. Implementation Plan 44 10. Conclusions 47 Annexes 49 Annex 1: Committee Members, Speakers and Participants 51 Annex 2: Glossary 55 Annex 3: Future Outlook: Emerging Innovative Approaches for Effective Integration 58 of Medical Research in Clinical Practice Annex 4: How Regulators can Help 62 Annex 5: Best Practice Example – TMF, Berlin, Germany 63 Annex 6: Patient and Public Involvement 64 Annex 7: References 66 2 | Forward Look – Implementation of Medical Research in Clinical Practice Executive Summary Medical care has improved beyond recognition over government agencies; the different approaches have the past half century. An important contribution to this advantages and disadvantages. However, in general improvement has been through clinical research. Clinical there is little evidence relating to the best way to ensure research includes different stages from basic-oriented that research is implemented and research in this area research, disease-oriented research with animal models, is needed. For the future, systematic clinical practice translational research, patient-oriented research and guidelines of the highest quality is the way to go, to outcome research. assure implementation of the right research results in When clinical research has been successfully imple- clinical practice – so that EbM is used in each and every mented in clinical practice it can answer important patient treatment, everywhere. questions relevant to practitioners and provide the evi- A key way to improve quality of care is through audit dence necessary to underpin practice. and feedback. Quality indicators can be valuable but need to be constructed with caution. Registries can It is important however, not to remain complacent also provide a rich source of information and they can and to strive for continual improvement. There is still be used for the generation of new research. much clinical decision-making that is not informed by evidence, and research which is carried out in a way Primary care has a key role to play in both research that is not methodologically robust. and implementation, given that family doctors encounter almost the whole population, whereas fewer people go This Forward Look examines how the quality of into hospital. Research results derived from special- research can be improved, and how research results can ist areas of medicine can be difficult to implement into better be implemented in practice. These issues were general practice because people who see their family comprehensively analysed and finally discussed and doctor often have a multiplicity of medical conditions debated by more than 90 leading experts from Europe that influence each other. There is a need to gain better and the rest of the world in a series of workshops culmi- knowledge relating to primary care. nating in a consensus conference held in October 2010 at the Council of Europe in Strasbourg. We need greater involvement of the public at all stages of research, and healthcare professionals should be well After rigorous debate and discussion, identifying gaps equipped to communicate about research – including and highlighting best practice, a number of recommen- issues such as risk. Funding agencies should require dations and conclusions were drawn, the principal of researchers to report their plans for involving patients which were as follows: and the public in their research project. Patient-oriented research questions should be framed The ten recommendations in this Forward Look are so that they address problems that are relevant to end- our attempt to summarise the many relevant and impor- users of research: patients and the public. It is important tant recommendations in this report – gathered and not to waste resources on duplicating research – seeking developed to improve the quality of research and to to answer questions that have already been answered; improve the quality of patient treatment and healthcare, this can be avoided by carrying out systematic reviews for patients and the public – here in Europe and globally. of the literature. The full set of recommendations can be found in the Research must be methodologically sound so that report (page 41). the answers it delivers can be viewed with confidence and used with confidence. The protocols and results of all clinical trials should be made publicly available and reported in an unbiased way and with adequate detail. There need to be more studies on the comparative effectiveness of drugs and other technologies and toxico- logical and clinical information should be made public. Education and training for clinical researchers are not well developed and there is an insufficient number of professionals with expertise in methodology, or an understanding of evidence-based medicine (EbM), health technology assessment and health economics. Clinical practice guidelines are one important way to implement research findings. Various models exist to produce guidelines, including those produced by sci- entific learned societies and those produced by central Forward Look – Implementation of Medical Research in Clinical Practice | 3 Executive Summary The top recommendations to strengthen implementation of medical research in clinical practice are the following: 1. Strengthen European work, collaboration on, coordination in and funding of systematic reviews of existing evidence, comparative effectiveness research, health technology assessments, and clinical practice guidelines. 2. Foster transparency and require evidence on comparative effectiveness and costs of drugs and other new technologies to demonstrate added value before approval. 3. Improve education and training of and career structure for health professionals. 4. When relevant, inform
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