title: Independent academic Data Monitoring Committees for clinical trials in cardiovascular and cardiometabolic diseases.
abstract: Data Monitoring Committees (DMCs) play a crucial role in the conducting of clinical trials to ensure the safety of study participants and to maintain a trial's scientific integrity. Generally accepted standards exist for DMC composition and operational conduct. However, some relevant issues are not specifically addressed in current guidance documents, resulting in uncertainties regarding optimal approaches for communication between the DMC, steering committee, and sponsors, release of information, and liability protection for DMC members. The Heart Failure Association (HFA) of the European Society of Cardiology (ESC), in collaboration with the Clinical Trials Unit of the European Heart Agency (EHA) of the ESC convened a meeting of international experts in DMCs for cardiovascular and cardiometabolic clinical trials to identify specific issues and develop steps to resolve challenges faced by DMCs.The main recommendations from the meeting relate to methodological consistency, independence, managing conflicts of interest, liability protection, and training of future DMC members. This paper summarizes the key outcomes from this expert meeting, and describes the core set of activities that might be further developed and ultimately implemented by the ESC, HFA, and other interested ESC constituent bodies. The HFA will continue to work with stakeholders in cardiovascular and cardiometabolic clinical research to promote these goals.
authors.affiliation: National and Kapodistrian University of Athens, School of Medicine, Athens University Hospital Attikon, Athens, Greece.
authors.forename: Gerasimos S
authors.initials: GS
authors.lastname: Filippatos
authors.affiliation: Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Centre Groningen, Groningen, the Netherlands.|Dutch Medicines Evaluation Board (CBG-MEB), Utrecht, the Netherlands.
authors.forename: Pieter
authors.initials: P
authors.lastname: de Graeff
authors.affiliation: Department of Cardiology, Leiden University Medical Centre, Leiden, the Netherlands.
authors.forename: Jeroen J
authors.initials: JJ
authors.lastname: Bax
authors.affiliation: Medicines Authority, Malta.
authors.forename: John-Joseph
authors.initials: JJ
authors.lastname: Borg
authors.affiliation: National Heart and Lung Institute, Royal Brompton and Harefield Hospitals, Imperial College, London, UK.
authors.forename: John G F
authors.initials: JG
authors.lastname: Cleland
authors.affiliation: Cardiology Department, Western Infirmary, Glasgow, Scotland, UK.
authors.forename: Henry J
authors.initials: HJ
authors.lastname: Dargie
authors.affiliation: Norfolk and Norwich University Hospitals NHS Foundation Trust and Norwich Medical School, University of East Anglia, Norfolk, UK.
authors.forename: Marcus
authors.initials: M
authors.lastname: Flather
authors.affiliation: Robertson Centre for Biostatistics, University of Glasgow, Glasgow, UK.
authors.forename: Ian
authors.initials: I
authors.lastname: Ford
authors.affiliation: Department of Medical Statistics, University Medical Centre Göttingen, Germany.|DZHK (German Centre for Cardiovascular Research), partner site Göttingen, Göttingen, Germany.
authors.forename: Tim
authors.initials: T
authors.lastname: Friede
authors.affiliation: University of California at San Diego, CA, USA.
authors.forename: Barry
authors.initials: B
authors.lastname: Greenberg
authors.affiliation: Servier, Suresnes, France.
authors.forename: Cécile
authors.initials: C
authors.lastname: Henon-Goburdhun
authors.affiliation: Minneapolis, MN, USA.
authors.forename: Richard
authors.initials: R
authors.lastname: Holcomb
authors.affiliation: Boston Scientific, St Paul, MN, USA.
authors.forename: Bradley
authors.initials: B
authors.lastname: Horst
authors.affiliation: National and Kapodistrian University of Athens, School of Medicine, Athens University Hospital Attikon, Athens, Greece.
authors.forename: John
authors.initials: J
authors.lastname: Lekakis
authors.affiliation: Novartis Pharma AG, Basel, Switzerland.
authors.forename: Guenther
authors.initials: G
authors.lastname: Mueller-Velten
authors.affiliation: Department of Biological Chemistry, Medical School, National and Kapodistrian University of Athens, Athens, Greece.|National Ethics Committee for Clinical Trials, Athens, Greece.
authors.forename: Athanasios G
authors.initials: AG
authors.lastname: Papavassiliou
authors.affiliation: UK Medicines and Healthcare Products Regulatory Agency, London, UK.|St Thomas' Hospital, London, UK.
authors.forename: Krishna
authors.initials: K
authors.lastname: Prasad
authors.affiliation: IRCCS San Raffaele Hospital Roma, Rome, Italy.|Cardiovascular and Cell Sciences Institute, St George's University of London, London, UK.
authors.forename: Giuseppe M C
authors.initials: GM
authors.lastname: Rosano
authors.affiliation: Novartis Pharma AG, Basel, Switzerland.
authors.forename: Thomas
authors.initials: T
authors.lastname: Severin
authors.affiliation: LoneStar Heart, Irvine, CA, USA.
authors.forename: Warren
authors.initials: W
authors.lastname: Sherman
authors.affiliation: Campbell University College of Pharmacy and Health Sciences, Cary, NC, USA.
authors.forename: Wendy Gattis
authors.initials: WG
authors.lastname: Stough
authors.affiliation: Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.|National Heart and Lung Institute, Imperial College, London, UK.
authors.forename: Karl
authors.initials: K
authors.lastname: Swedberg
authors.affiliation: GVM Care and Research, ES Health Science Foundation, Maria Cecilia Hospital, Cotignola, Italy.
authors.forename: Luigi
authors.initials: L
authors.lastname: Tavazzi
authors.affiliation: 1st Department of Cardiology, Hippokration Hospital, University of Athens, Athens, Greece.
authors.forename: Dimitris
authors.initials: D
authors.lastname: Tousoulis
authors.affiliation: Department of Cardiology, Heraklion University Hospital, Crete, Greece.
authors.forename: Panagiotis
authors.initials: P
authors.lastname: Vardas
authors.affiliation: Department of Cardiology, Heart Failure Clinic and Transplantation, University Heart Centre Zurich, Zurich, Switzerland.
authors.forename: Frank
authors.initials: F
authors.lastname: Ruschitzka
authors.affiliation: Innovative Clinical Trials, Department of Cardiology and Pneumology, University Medical Centre Göttingen (UMG), Robert-Koch-Strasse 40, D-37075, Göttingen, Germany.
authors.forename: Stefan D
authors.initials: SD
authors.lastname: Anker
mesh_terms: D035843:Biomedical Research; D002318:Cardiovascular Diseases; D026661:Clinical Trials Data Monitoring Committees / Q000458:organization & administration*; D002986:Clinical Trials as Topic / Q000458:organization & administration*; D017408:Guidelines as Topic; D006801:Humans; D008659:Metabolic Diseases
keywords: Cardiovascular diseases; Clinical trials; Clinical trials as topic; Data Monitoring Committees; Data safety monitoring board