Journal
EUROPEAN JOURNAL OF HEART FAILURE
Volume 19, Issue 6, Pages 718-727Publisher
WILEY
DOI: 10.1002/ejhf.809
Keywords
Heart failure; Clinical trial; Drug approval
Categories
Funding
- ResMed
- Boston Scientific
- Bayer
- Novartis
- Servier
- Pfizer
- AstraZeneca
- Medtronic
- St Jude Medical
- Vifor Resenius
- Vifor
- Vifor International
- Abbott Vascular
- Boehringer Ingelheim
- Merck Co., Inc.
- Amgen
- Takeda-Menarini
- Sanofi
- Menarini
- Ferring Pharmaceuticals
- Onyx Pharmaceuticals
- Stealth Peptides
- Cardiorentis
- Oxford University
- GlaxoSmithKline
- Theracos
- Abbvie
- DalCor
- Bristol Myers Squibb
- Kidney Research UK/Kings College Hospital London/Vifor-Fresenius Pharma
- Relypsa
- Genzyme Corporation
- Lilly USA
- Medicines Company
- Novo Nordisk
- Teva
- Thrasos
- Gilead
- Vifor Pharma
- Johnson Johnson
- Respicardia
- Coridea
- Celladon
- Singulex
- Biocontrol
- DD Device
- Viromed
- Ventrix
- European Society of Cardiology
- Heart Failure Association of the European Society of Cardiology
- Heart Failure Society of America
- Overcome [Cardiovascular Clinical Trialists (CVCT) and Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists [INI-(CRCT)]
- Celyad
Ask authors/readers for more resources
Despite the availability of a number of different classes of therapeutic agents with proven efficacy in heart failure, the clinical course of heart failure patients is characterized by a reduction in life expectancy, a progressive decline in health-related quality of life and functional status, as well as a high risk of hospitalization. New approaches are needed to address the unmet medical needs of this patient population. The European Medicines Agency (EMA) is undertaking a revision of its Guideline on Clinical Investigation of Medicinal Products for the Treatment of Chronic Heart Failure. The draft version of the Guideline was released for public consultation in January 2016. The Cardiovascular Round Table of the European Society of Cardiology (ESC), in partnership with the Heart Failure Association of the ESC, convened a dedicated two-day workshop to discuss three main topic areas of major interest in the field and addressed in this draft EMA guideline: (i) assessment of efficacy (i.e. endpoint selection and statistical analysis); (ii) clinical trial design (i.e. issues pertaining to patient population, optimal medical therapy, run-in period); and (iii) research approaches for testing novel therapeutic principles (i.e. cell therapy). This paper summarizes the key outputs from the workshop, reviews areas of expert consensus, and identifies gaps that require further research or discussion. Collaboration between regulators, industry, clinical trialists, cardiologists, health technology assessment bodies, payers, and patient organizations is critical to address the ongoing challenge of heart failure and to ensure the development and market access of new therapeutics in a scientifically robust, practical and safe way.
Authors
I am an author on this paper
Click your name to claim this paper and add it to your profile.
Reviews
Recommended
No Data Available