Moving forward from drug-centred to patient-centred research
Authors: Denis Lacombe, Colm O'Morain, Barbara Casadei, Kate Hill, Elsa Mateus, Rik Lories, Guy Brusselle
Journal: European Respiratory Journal (2019)

Maximising the potential of precision medicine for patients and healthcare services is a major societal challenge. It requires a holistic approach to the development of therapeutic strategies and a re-thinking of the entire process, including the role of the respective stakeholders and the way they interact, from the early steps of drug development to access in real life. First, the new technologies that inform us about the biology of the disease and enable better treatments plead for a reversal of the "protocols search patients" approach, to "patients searching (the best possible) treatments and protocols". Second, new drugs reaching the market is not an end but a start. Information that is critical for the integration of new treatments in daily practice needs to be collected and analysed to optimise the use of resources and maximise patient benefits. Optimal dose, sequence, combination and duration of treatments as well as cut-off values of biomarkers and their clinical utility all represent crucial pieces of information not only for patients and doctors, but also for healthcare systems facing complex decisions on reimbursement and access. The gap that currently exists between market approval and real-life clinical practice, and that is not addressed by the commercial sector, requires a new infrastructure for applied clinical research which needs to be fully integrated into the cycle of drug development, market approval and clinical application. This process needs to be re-engineered in a such a way that it truly serves the needs of patients and generates the data needed to inform clinical practice. This paper discusses how to restructure the process of clinical research to maximise the potential of precision medicine <http://ow.ly/1ZCc30nuw2a> The authors thank the following people for their contribution to the article: Ioana Agache (President, EAACI), Peter Van Den Bergh (Member of European Affairs Subcommittee, EAN), Kristoff Muylle (President, EANM), Lale Tokgözoglu (President, EAS), Alberico Catapano (Past President, EAS), Anders Bjartell (Chairman of the EAU Research Foundation, EAU), Javier Gisbert (Clinical Research Committee, ECCO-IBD), Guy Joos (Past President, ERS), Roy Farquharson (Chairman, ESHRE), Tony Lahoutte (President, ESMI), Marc Benninga (Member and Treasurer of Gastroenterology Committee, ESPGHAN), Emmanuel Fragkoulis (Chair of the Science and Society Committee, FEBS), Isabel Varela Nieto (Member of the Science and Society Committee, FEBS), Frank Rümmele (Member of Research Board, UEG). Endorsed by the Board of Directors of Biomedical Alliance in Europe (BioMed Alliance; [www.biomedeurope.org][1]) and the Academic Clinical Trials Task Force which is composed of the following BioMed Alliance member societies: European Academy of Allergy and Clinical Immunology (EAACI; [www.eaaci.org][2]), European Academy of Neurology (EAN; [www.ean.org][3]), European Association for Study of the Liver (EASL; [www.easl.eu][4]), European Association for the Study of Obesity (EASO; [www.easo.org][5]), European Association of Nuclear Medicine (EANM; [www.eanm.org][6]), European Association of Urology (EAU; [www.uroweb.org][7]), European Atherosclerosis Society (EAS; [www.eas-society.org][8]), European CanCer Organisation (ECCO; [www.ecco-org.eu][9]), European Crohn's and Colitis Organisation (ECCO-IBD; [www.ecco-ibd.eu][10]), European Hematology Association (EHA; [www.ehaweb.org][11]), European League Against Rheumatism (EULAR; [www.eular.org][12]), European Organisation for Research and Treatment of Cancer (EORTC; [www.eortc.org][13]), European Respiratory Society (ERS; [www.ersnet.org][14]), European Society for Molecular Imaging (ESMI; [www.e-smi.eu][15]), European Society for Paediatric Gastroenterology Hepatology and Nutrition (ESPGHAN; [www.espghan.org][16]), European Society of Anaesthesiology (ESA; [www.esahq.org][17]), European Society of Cardiology (ESC; [www.escardio.org][18]), European Society of Human Reproduction and Embryology (ESHRE; [www.eshre.eu][19]), Federation of European Biochemical Societies (FEBS; [www.febs.org][20]), United European Gastroenterology (UEG; [www.ueg.eu][21]). The Biomedical Alliance in Europe (the BioMed Alliance) has 29 members, all of whom are scientific and professional medical associations, which are active in all aspects of their specialties across the whole of Europe. It was created in 2010 to establish a mechanism for biomedical and clinical researchers to provide a collective voice to the European Institutions in support of medical research. The BioMed Alliance's principal goals and objectives are to promote the best interests and values of researchers and of healthcare professionals, organised in non-for-profit scientific medical associations and organisations across all medical disciplines in Europe, in those general areas where common interest is identified. The BioMed Alliance's scientific societies collaborate closely with European-wide patient organisations in the respective disease domains in order to improve patient outcomes and to strengthen patient participation in clinical research. The BioMed Alliance has advocated for an increase in funding for Horizon Europe (particularly for health research) and for the implementation of structural measures to accommodate sustainability for research programmes and to streamline activities aiming to support basic research and collaborative translational biomedical research, and to close the gap between basic research and clinical practice. The BioMed Alliance has been advocating for bottom-up initiatives in designing health research programmes, for more visibility of EU research, and for precision medicine-based patient-centred solutions in designing and conducting clinical trials. [1]: http://www.biomedeurope.org [2]: http://www.eaaci.org [3]: http://www.ean.org [4]: http://www.easl.eu [5]: http://www.easo.org [6]: http://www.eanm.org [7]: http://www.uroweb.org [8]: http://www.eas-society.org [9]: http://www.ecco-org.eu [10]: http://www.ecco-ibd.eu [11]: http://www.ehaweb.org [12]: http://www.eular.org [13]: http://www.eortc.org [14]: http://www.ersnet.org [15]: http://www.e-smi.eu [16]: http://www.espghan.org [17]: http://www.esahq.org [18]: http://www.escardio.org [19]: http://www.eshre.eu [20]: http://www.febs.org [21]: http://www.ueg.eu