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|Title: ||Improving public health by improving clinical trial guidelines and their application|
|Authors: ||Landray, Martin J.|
Bax, Jeroen J.
James, Stefan K.
Maggioni, Aldo P.
Pocock, Stuart J.
Sipido, Karin R.
Stewart, Murray W.
Stough, Wendy Gattis
Van de Werf, Frans
|Issue Date: ||2017|
|Publisher: ||OXFORD UNIV PRESS|
|Citation: ||EUROPEAN HEART JOURNAL, 38(21), p. 1632-1637b|
|Abstract: ||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.|
|Notes: ||[Landray, Martin J.; Collins, Rory] Univ Oxford, Nuffield Dept Populat Hlth, Clin Trial Serv Unit, Oxford, England. [Bax, Jeroen J.] Leiden Univ, Med Ctr, Dept Cardiol, Leiden, Netherlands. [Alliot, Laurence] Servier, Paris, France. [Buyse, Marc] IDDI, Louvain La Neuve, Belgium. [Buyse, Marc] CluePoints, Louvain La Neuve, Belgium. [Buyse, Marc] Univ Hasselt, Hasselt, Belgium. [Cohen, Adam] Ctr Human Drug Res, Leiden, Netherlands. [Hindricks, Gerhard] Univ Leipzig, Heart Ctr, Dept Elect, Leipzig, Germany. [James, Stefan K.] Uppsala Univ, Uppsala Clin Res Ctr, Dept Med Sci Cardiol, Uppsala, Sweden. [Lane, Sile] Sense Sci, London, England. [Maggioni, Aldo P.] ANMCO Res Ctr, Florence, Italy. [Meeker-O'Connell, Ann] Johnson & Johnson, New Brunswick, NJ USA. [Olsson, Gunnar] European Soc Cardiol, Jonkoping, Sweden. [Pocock, Stuart J.; Smeeth, Liam] London Sch Hyg & Trop Med, Dept Med Stat, London, England. [Rawlins, Michael] Med & Healthcare Prod Regulatory Agcy, London, England. [Sellors, Jonathan] Howard Kennedy, LLP, London, England. [Shinagawa, Kaori] Pharmaceut & Med Devices Agcy, Tokyo, Japan. [Sipido, Karin R.] Univ Leuven, KU Leuven, Dept Cardiovasc Sci Expt Cardiol, Leuven, Belgium. [Stephens, Richard] Natl Inst Canc Res, Consumer Lead, London, England. [Stewart, Murray W.] GlaxoSmithKline, Philadelphia, PA USA. [Stough, Wendy Gattis] Campbell Univ, Coll Pharm & Hlth Sci, Buies Creek, NC 27506 USA. [Sweeney, Fergus] European Med Agcy, London, England. [Van de Werf, Frans] Univ Hosp, Dept Cardiovasc Sci, Leuven, Belgium. [Woods, Kerrie] Natl Inst Hlth Res, Natl Hlth Serv, London, England. [Casadei, Barbara] Univ Oxford, John Radcliffe Hosp, Div Cardiovasc Med, Radcliffe Dept Med, Level 6,West Wing, Oxford OX3 9DU, England.|
|ISI #: ||000402720300006|
|Type: ||Journal Contribution|
|Appears in Collections: ||Research publications|
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