Improving clinical trials for cardiovascular diseases: a position paper from the Cardiovascular Round Table of the European Society of Cardiology

Autor: Dominik Lautsch, Nilesh J. Samani, Guenter Breithardt, Dan Atar, Matthias Endres, Peter G. M. Mol, Hakima Hannachi, Maria Borentain, Anders Svensson, Andrew Zalewski, Paulus Kirchhof, Chantal Le Floch, Uwe Fraass, Salim Janmohamed, Jackson Neville Colin, Huseyin Naci, Martin J Landray, Jan G.P. Tijssen, Joerg Kreuzer, Tim Friede, Cathrine Thorstensen, Martin van Eickels, Victoria Vandzhura
Přispěvatelé: Real World Studies in PharmacoEpidemiology, -Genetics, -Economics and -Therapy (PEGET), Cardiology
Jazyk: angličtina
Rok vydání: 2015
Předmět:
Technology Assessment
Biomedical
MONOCLONAL-ANTIBODY
030204 cardiovascular system & hematology
Cardiovascular
PLACEBO-CONTROLLED TRIAL
DOUBLE-BLIND
0302 clinical medicine
Clinical trials
Cost of Illness
Drug Discovery
Medicine
030212 general & internal medicine
Precision Medicine
Health technology assessment
Drug Approval
New therapies
Societies
Medical
Pharmaceutical industry
Clinical Trials as Topic
Cardiovascular disease burden
Data Collection
Therapies
Investigational
Health technology
C-REACTIVE PROTEIN
Europe
KEY DATA ELEMENTS
Drug development
Cardiovascular Diseases
Costs and Cost Analysis
Cardiology
Cardiology and Cardiovascular Medicine
medicine.medical_specialty
Drug Industry
Interprofessional Relations
HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA
03 medical and health sciences
Internal medicine
Humans
CORONARY-HEART-DISEASE
ASSOCIATION TASK-FORCE
business.industry
SUBTILISIN/KEXIN TYPE 9
Information technology
Personalized medicine
Clinical trial
HIGH-RISK
Cardiovascular agent
Position paper
business
Zdroj: European Heart Journal, 37(9), 747-754. Oxford University Press
European heart journal, 37(9), 747-754. Oxford University Press
ISSN: 1522-9645
0195-668X
Popis: 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.
Databáze: OpenAIRE
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