Neville Jackson1, Dan Atar2, Maria Borentain3, Günter Breithardt4, Martin van Eickels5, Matthias Endres6, Uwe Fraass7, Tim Friede8, Hakima Hannachi9, Salim Janmohamed10, Jörg Kreuzer11, Martin Landray12, Dominik Lautsch9, Chantal Le Floch13, Peter Mol14, Huseyin Naci15, Nilesh J Samani16, Anders Svensson17, Cathrine Thorstensen1, Jan Tijssen18, Victoria Vandzhura13, Andrew Zalewski19, Paulus Kirchhof20. 1. Pfizer, Inc., Groton, CT, USA. 2. Oslo University Hospital Ulleval and University of Oslo, Oslo, Norway. 3. Bristol-Myers Squibb, Paris, France. 4. Department of Cardiovascular Medicine, Universitätsklinikum Münster, Münster, Germany Centre for Cardiovascular Sciences, School of Clinical and Experimental Medicine, University of Birmingham and Sandwell and West Birmingham Hospitals National Health Service Trust, Wolfson Drive, Birmingham B15 2TT, UK. 5. Bayer Healthcare, Berlin, Germany. 6. Charité-Universitätsmedizin, Berlin, Germany. 7. Amgen, Inc., Munich, Germany. 8. Department of Medical Statistics, University Medical Center, Göttingen, Germany DZHK (German Centre for Cardiovascular Research), Partner Site Göttingen, Göttingen, Germany. 9. Merck Inc., Cokesbury, NJ, USA. 10. GlaxoSmithKline, Heathrow, London, UK. 11. Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim, Germany. 12. University of Oxford, Oxford, UK. 13. Servier, Paris, France. 14. Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands Dutch Medicines Evaluation Board, Utrecht, The Netherlands. 15. London School of Economics and Political Science, London, UK. 16. University of Leicester, Leicester, UK. 17. Roche, Inc., Basel, Switzerland. 18. Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands. 19. GlaxoSmithKline, King of Prussia, PA, USA. 20. Centre for Cardiovascular Sciences, School of Clinical and Experimental Medicine, University of Birmingham and Sandwell and West Birmingham Hospitals National Health Service Trust, Wolfson Drive, Birmingham B15 2TT, UK Atrial Fibrillation Competence NETwork (AFNET) e.V., Münster, Germany p.kirchhof@bham.ac.uk.
Abstract
AIMS: Cardiovascular disease is the most common cause of mortality and morbidity in the world, but the pharmaceutical industry's willingness to invest in this field has declined because of the many challenges involved with bringing new cardiovascular drugs to market, including late-stage failures, escalating regulatory requirements, bureaucracy of the clinical trial business enterprise, and limited patient access after approval. This contrasts with the remaining burden of cardiovascular disease in Europe and in the world. Thus, clinical cardiovascular research needs to adapt to address the impact of these challenges in order to ensure development of new cardiovascular medicines. METHODS AND RESULTS: The present paper is the outcome of a two-day workshop held by the Cardiovascular Round Table of the European Society of Cardiology. We propose strategies to improve development of effective new cardiovascular therapies. These can include (i) the use of biomarkers to describe patients who will benefit from new therapies more precisely, achieving better human target validation; (ii) targeted, mechanism-based approaches to drug development for defined populations; (iii) the use of information technology to simplify data collection and follow-up in clinical trials; (iv) streamlining adverse event collection and reducing monitoring; (v) extended patent protection or limited rapid approval of new agents to motivate investment in early phase development; and (vi) collecting data needed for health technology assessment continuously throughout the drug development process (before and after approval) to minimize delays in patient access. Collaboration across industry, academia, regulators, and payers will be necessary to enact change and to unlock the existing potential for cardiovascular clinical drug development. CONCLUSIONS: A coordinated effort involving academia, regulators, industry, and payors will help to foster better and more effective conduct of clinical cardiovascular trials, supporting earlier availability of innovative therapies and better management of cardiovascular diseases. Published on behalf of the European Society of Cardiology. All rights reserved.
AIMS: Cardiovascular disease is the most common cause of mortality and morbidity in the world, but the pharmaceutical industry's willingness to invest in this field has declined because of the many challenges involved with bringing new cardiovascular drugs to market, including late-stage failures, escalating regulatory requirements, bureaucracy of the clinical trial business enterprise, and limited patient access after approval. This contrasts with the remaining burden of cardiovascular disease in Europe and in the world. Thus, clinical cardiovascular research needs to adapt to address the impact of these challenges in order to ensure development of new cardiovascular medicines. METHODS AND RESULTS: The present paper is the outcome of a two-day workshop held by the Cardiovascular Round Table of the European Society of Cardiology. We propose strategies to improve development of effective new cardiovascular therapies. These can include (i) the use of biomarkers to describe patients who will benefit from new therapies more precisely, achieving better human target validation; (ii) targeted, mechanism-based approaches to drug development for defined populations; (iii) the use of information technology to simplify data collection and follow-up in clinical trials; (iv) streamlining adverse event collection and reducing monitoring; (v) extended patent protection or limited rapid approval of new agents to motivate investment in early phase development; and (vi) collecting data needed for health technology assessment continuously throughout the drug development process (before and after approval) to minimize delays in patient access. Collaboration across industry, academia, regulators, and payers will be necessary to enact change and to unlock the existing potential for cardiovascular clinical drug development. CONCLUSIONS: A coordinated effort involving academia, regulators, industry, and payors will help to foster better and more effective conduct of clinical cardiovascular trials, supporting earlier availability of innovative therapies and better management of cardiovascular diseases. Published on behalf of the European Society of Cardiology. All rights reserved.
Keywords:
Cardiovascular; Cardiovascular disease burden; Clinical trials; Drug development; Health technology assessment; New therapies; Personalized medicine
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