title: Challenges to Data Monitoring Committees When Regulatory Authorities Intervene.
authors.affiliation: From the Department of Molecular and Clinical Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden (K.S.); the National Heart and Lung Institute, Imperial College London (K.S.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.P.) - both in London; the Division of Cardiovascular Medicine, Howard Gilman Institute for Heart Valve Disease and Schiavone Institute for Cardiovascular Translational Research, State University of New York Downstate Medical Center, New York (J.S.B.); the University of Michigan School of Medicine, Ann Arbor (B.P.); and the Institut de Cardiologie de Montréal, Université de Montréal, Montreal (J.R.).
authors.forename: Karl
authors.initials: K
authors.lastname: Swedberg
authors.affiliation: From the Department of Molecular and Clinical Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden (K.S.); the National Heart and Lung Institute, Imperial College London (K.S.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.P.) - both in London; the Division of Cardiovascular Medicine, Howard Gilman Institute for Heart Valve Disease and Schiavone Institute for Cardiovascular Translational Research, State University of New York Downstate Medical Center, New York (J.S.B.); the University of Michigan School of Medicine, Ann Arbor (B.P.); and the Institut de Cardiologie de Montréal, Université de Montréal, Montreal (J.R.).
authors.forename: Jeffrey S
authors.initials: JS
authors.lastname: Borer
authors.affiliation: From the Department of Molecular and Clinical Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden (K.S.); the National Heart and Lung Institute, Imperial College London (K.S.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.P.) - both in London; the Division of Cardiovascular Medicine, Howard Gilman Institute for Heart Valve Disease and Schiavone Institute for Cardiovascular Translational Research, State University of New York Downstate Medical Center, New York (J.S.B.); the University of Michigan School of Medicine, Ann Arbor (B.P.); and the Institut de Cardiologie de Montréal, Université de Montréal, Montreal (J.R.).
authors.forename: Bertram
authors.initials: B
authors.lastname: Pitt
authors.affiliation: From the Department of Molecular and Clinical Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden (K.S.); the National Heart and Lung Institute, Imperial College London (K.S.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.P.) - both in London; the Division of Cardiovascular Medicine, Howard Gilman Institute for Heart Valve Disease and Schiavone Institute for Cardiovascular Translational Research, State University of New York Downstate Medical Center, New York (J.S.B.); the University of Michigan School of Medicine, Ann Arbor (B.P.); and the Institut de Cardiologie de Montréal, Université de Montréal, Montreal (J.R.).
authors.forename: Stuart
authors.initials: S
authors.lastname: Pocock
authors.affiliation: From the Department of Molecular and Clinical Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden (K.S.); the National Heart and Lung Institute, Imperial College London (K.S.) and the Department of Medical Statistics, London School of Hygiene and Tropical Medicine (S.P.) - both in London; the Division of Cardiovascular Medicine, Howard Gilman Institute for Heart Valve Disease and Schiavone Institute for Cardiovascular Translational Research, State University of New York Downstate Medical Center, New York (J.S.B.); the University of Michigan School of Medicine, Ann Arbor (B.P.); and the Institut de Cardiologie de Montréal, Université de Montréal, Montreal (J.R.).
authors.forename: Jean
authors.initials: J
authors.lastname: Rouleau
mesh_terms: D000577:Amides / Q000009:adverse effects* / Q000627:therapeutic use; D000806:Angiotensin-Converting Enzyme Inhibitors / Q000627:therapeutic use; D026661:Clinical Trials Data Monitoring Committees; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D005650:Fumarates / Q000009:adverse effects* / Q000627:therapeutic use; D033161:Government Regulation; D006333:Heart Failure / Q000188:drug therapy; D006801:Humans; D016032:Randomized Controlled Trials as Topic; D000092502:Renin Inhibitors
chemical_list: D000577:Amides; D000806:Angiotensin-Converting Enzyme Inhibitors; D005650:Fumarates; D000092502:Renin Inhibitors; C446481:aliskiren