Improving public health by improving clinical trial guidelines and their application

• Published in: European heart journal 2017-06, Vol.38 (21), p.1632-1637
• Main Authors: Landray, Martin J, Bax, Jeroen J, Alliot, Laurence, Buyse, Marc, Cohen, Adam, Collins, Rory, Hindricks, Gerhard, James, Stefan K, Lane, Sile, Maggioni, Aldo P, Meeker-O'Connell, Ann, Olsson, Gunnar, Pocock, Stuart J, Rawlins, Michael, Sellors, Jonathan, Shinagawa, Kaori, Sipido, Karin R, Smeeth, Liam, Stephens, Richard, Stewart, Murray W, Stough, Wendy Gattis, Sweeney, Fergus, Van de Werf, Frans, Woods, Kerrie, Casadei, Barbara
• Format: Article
• Language: English
• Subjects: Cardiology - education; Cardiology - ethics; Cardiology - standards; Cardiovascular diseases; Clinical trials; Current Opinion; Diffusion of Innovation; Disclosure; Humans; Informed Consent; Patient Safety; Practice Guidelines as Topic; Pragmatic clinical trials; Public Health - standards; Quality Assurance, Health Care; Randomized controlled trials; Randomized Controlled Trials as Topic - ethics; Randomized Controlled Trials as Topic - standards; Risk Assessment
• ISSN: 0195-668X; 1522-9645; 1522-9645
• DOI: 10.1093/eurheartj/ehx086

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.