Improving public health by improving clinical trial guidelines and their application.
Evidence generated from randomized controlled trials forms the foundation of cardiovascular therapeutics and has led to the adoption of numerous drugs and devices that prolong survival and reduce morbidity, as well as the avoidance of interventions that have been shown to be ineffective or even unsafe. Many aspects of cardiovascular research have evolved considerably since the first randomized trials in cardiology were conducted. In order to be large enough to provide reliable evidence about effects on major outcomes, cardiovascular trials may now involve thousands of patients recruited from hundreds of clinical sites in many different countries. Costly infrastructure has developed to meet the increasingly complex organizational and operational requirements of these clinical trials. Concerns have been raised that this approach is unsustainable, inhibiting the reliable evaluation of new and existing treatments, to the detriment of patient care. These issues were considered by patients, regulators, funders, and trialists at a meeting of the European Society of Cardiology Cardiovascular Roundtable in October 2015. This paper summarizes the key insights and discussions from the workshop, highlights subsequent progress, and identifies next steps to produce meaningful change in the conduct of cardiovascular clinical research.
Clinical Trial Service Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.
Martin J
MJ
Landray
Department of Cardiology, Leiden University Medical Center, Leiden, The Netherlands.
Jeroen J
JJ
Bax
Servier, Paris, France.
Laurence
L
Alliot
IDDI and CluePoints, Louvain-la-Neuve, Belgium.|University of Hasselt, Hasselt, Belgium.
Marc
M
Buyse
Centre for Human Drug Research, Leiden, The Netherlands.
Adam
A
Cohen
Clinical Trial Service Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.
Rory
R
Collins
Department of Electrophysiology, Heart Center, University of Leipzig, Leipzig, Germany.
Gerhard
G
Hindricks
Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden.
Stefan K
SK
James
Sense About Science, London, UK.
Sile
S
Lane
ANMCO Research Center, Florence, Italy.
Aldo P
AP
Maggioni
Johnson & Johnson, New Brunswick, New Jersey, USA.
Ann
A
Meeker-O'Connell
Board Member (advisory) of European Society of Cardiology, Sweden.
Gunnar
G
Olsson
Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, UK.
Stuart J
SJ
Pocock
Medicines and Healthcare products Regulatory Agency, London, UK.
Michael
M
Rawlins
LLP, Howard Kennedy, London, UK.
Jonathan
J
Sellors
Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
Kaori
K
Shinagawa
Department of Cardiovascular Sciences, Experimental Cardiology, KU Leuven, University of Leuven, Leuven, Belgium.
Karin R
KR
Sipido
Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, UK.
Liam
L
Smeeth
Consumer Lead, National Cancer Research Institute, London, UK.
Richard
R
Stephens
GlaxoSmithKline, Philadelphia, PA, USA.
Murray W
MW
Stewart
Campbell University College of Pharmacy and Health Sciences, North Carolina, USA.
Wendy Gattis
WG
Stough
European Medicines Agency, London, UK.
Fergus
F
Sweeney
Department of Cardiovascular Sciences, University Hospitals, Leuven, Belgium.
Frans
F
Van de Werf
National Institute for Health Research, National Health Service, London, UK.
Kerrie
K
Woods
Radcliffe Department of Medicine, Division of Cardiovascular Medicine, John Radcliffe Hospital, University of Oxford, Level 6, West Wing, Oxford, OX3 9DU, UK.
Barbara
B
Casadei
D002309:Cardiology / Q000193:education / Q000941:ethics / Q000592:standards*; D004059:Diffusion of Innovation; D030881:Disclosure; D006801:Humans; D007258:Informed Consent; D061214:Patient Safety; D017410:Practice Guidelines as Topic; D011634:Public Health / Q000592:standards*; D011785:Quality Assurance, Health Care; D016032:Randomized Controlled Trials as Topic / Q000941:ethics / Q000592:standards*; D018570:Risk Assessment
Cardiovascular diseases; Clinical trials; Pragmatic clinical trials; Randomized controlled trials