title: Improving clinical trials for cardiovascular diseases: a position paper from the Cardiovascular Round Table of the European Society of Cardiology.
abstract: OBJECTIVE
  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.
  
  
  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.
authors.affiliation: Pfizer, Inc., Groton, CT, USA.
authors.forename: Neville
authors.initials: N
authors.lastname: Jackson
authors.affiliation: Oslo University Hospital Ulleval and University of Oslo, Oslo, Norway.
authors.forename: Dan
authors.initials: D
authors.lastname: Atar
authors.affiliation: Bristol-Myers Squibb, Paris, France.
authors.forename: Maria
authors.initials: M
authors.lastname: Borentain
authors.affiliation: 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.
authors.forename: Günter
authors.initials: G
authors.lastname: Breithardt
authors.affiliation: Bayer Healthcare, Berlin, Germany.
authors.forename: Martin
authors.initials: M
authors.lastname: van Eickels
authors.affiliation: Charité-Universitätsmedizin, Berlin, Germany.
authors.forename: Matthias
authors.initials: M
authors.lastname: Endres
authors.affiliation: Amgen, Inc., Munich, Germany.
authors.forename: Uwe
authors.initials: U
authors.lastname: Fraass
authors.affiliation: Department of Medical Statistics, University Medical Center, Göttingen, Germany DZHK (German Centre for Cardiovascular Research), Partner Site Göttingen, Göttingen, Germany.
authors.forename: Tim
authors.initials: T
authors.lastname: Friede
authors.affiliation: Merck Inc., Cokesbury, NJ, USA.
authors.forename: Hakima
authors.initials: H
authors.lastname: Hannachi
authors.affiliation: GlaxoSmithKline, Heathrow, London, UK.
authors.forename: Salim
authors.initials: S
authors.lastname: Janmohamed
authors.affiliation: Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim, Germany.
authors.forename: Jörg
authors.initials: J
authors.lastname: Kreuzer
authors.affiliation: University of Oxford, Oxford, UK.
authors.forename: Martin
authors.initials: M
authors.lastname: Landray
authors.affiliation: Merck Inc., Cokesbury, NJ, USA.
authors.forename: Dominik
authors.initials: D
authors.lastname: Lautsch
authors.affiliation: Servier, Paris, France.
authors.forename: Chantal
authors.initials: C
authors.lastname: Le Floch
authors.affiliation: Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands Dutch Medicines Evaluation Board, Utrecht, The Netherlands.
authors.forename: Peter
authors.initials: P
authors.lastname: Mol
authors.affiliation: London School of Economics and Political Science, London, UK.
authors.forename: Huseyin
authors.initials: H
authors.lastname: Naci
authors.affiliation: University of Leicester, Leicester, UK.
authors.forename: Nilesh J
authors.initials: NJ
authors.lastname: Samani
authors.affiliation: Roche, Inc., Basel, Switzerland.
authors.forename: Anders
authors.initials: A
authors.lastname: Svensson
authors.affiliation: Pfizer, Inc., Groton, CT, USA.
authors.forename: Cathrine
authors.initials: C
authors.lastname: Thorstensen
authors.affiliation: Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
authors.forename: Jan
authors.initials: J
authors.lastname: Tijssen
authors.affiliation: Servier, Paris, France.
authors.forename: Victoria
authors.initials: V
authors.lastname: Vandzhura
authors.affiliation: GlaxoSmithKline, King of Prussia, PA, USA.
authors.forename: Andrew
authors.initials: A
authors.lastname: Zalewski
authors.affiliation: 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.
authors.forename: Paulus
authors.initials: P
authors.lastname: Kirchhof
mesh_terms: D002318:Cardiovascular Diseases / Q000188:drug therapy* / Q000191:economics; D002986:Clinical Trials as Topic / Q000191:economics / Q000592:standards*; D017281:Cost of Illness; D003365:Costs and Cost Analysis / Q000191:economics; D003625:Data Collection; D017277:Drug Approval / Q000191:economics / Q000331:legislation & jurisprudence; D055808:Drug Discovery / Q000191:economics; D004345:Drug Industry / Q000191:economics; D005060:Europe; D006801:Humans; D007400:Interprofessional Relations; D057285:Precision Medicine / Q000191:economics; D012955:Societies, Medical; D013673:Technology Assessment, Biomedical / Q000191:economics; D035703:Therapies, Investigational / Q000191:economics
keywords: Cardiovascular; Cardiovascular disease burden; Clinical trials; Drug development; Health technology assessment; New therapies; Personalized medicine