Search Results - "data monitoring"

The Data Monitoring Experience in Empagliflozin Randomized Clinical Trials Between 2011 and 2024.

Welty FK; Division of Cardiology, Beth Israel Deaconess Medical Center, 330 Brookline Ave, Boston, MA, 02215, USA. francinewelty@gmail.com., Parhofer KG; Ludwig-Maximilians University Munich, Munich, Germany., Konstam M; The CardioVascular Center, Tufts Medical Center and Tufts University School of Medicine, Boston, MA, USA., Palmer MK; N Zero 1 Ltd, Wilmslow, UK., Greenberg B; Division of Cardiology, University of California at San Diego, La Jolla, CA, USA., Daher R; Cooper University Healthcare, Camden, NJ, USA., Clayton T; Department of Medical Statistics, London School of Hygiene & Tropical Medicine, London, UK.

Journal Article; Review , 2025

Monitoring in pragmatic trials lessons from the NIH pragmatic trials collaboratory.

Curtis LH; Duke University School of Medicine, Department of Population Health Sciences, Durham, NC, USA. Electronic address: lesley.curtis@duke.edu., Morain S; Johns Hopkins Bloomberg School of Public Health, Johns Hopkins Berman Institute of Bioethics, Baltimore, MD, USA., O'Rourke PP; Harvard Medical School (Retired), Boston, MA, USA., Staman K; Duke Clinical Research Institute, Durham, NC, USA., Jarvik JG; Department of Radiology and Clinical Learning, Evidence, and Research (CLEAR) Center, University of Washington, School of Medicine, Seattle, WA, USA., Cheville A; Mayo Clinic Comprehensive Cancer Center, Rochester, MN, USA., Dailey DL; Department of Physical Therapy, St. Ambrose University, Davenport, IA, Department of Physical Therapy and Rehabilitation Science, Carver College of Medicine, Iowa City, IA, USA; Department of Physical Therapy and Rehabilitation Science, Carver College of Medicine, Iowa City, IA, USA., Sluka KA; Department of Physical Therapy and Rehabilitation Science, Carver College of Medicine, Iowa City, IA, USA., Heagerty P; University of Washington, School of Public Health, Seattle, WA, USA., Melnick ER; Yale School of Medicine, Department of Emergency Medicine, New Haven, CT, USA., Chakraborty H; Duke University School of Medicine, Department of Biostatistics, Durham, NC, USA., Tulsky JA; Harvard Medical School, Boston, MA, USA; Department of Supportive Oncology, Dana-Farber Cancer Institute, Boston, MA, USA; Department of Medicine, Brigham and Women's Hospital, Boston, MA, USA., Volandes A; Harvard Medical School, Boston, MA, USA; Department of Medicine, Massachusetts General Hospital, Boston, MA, USA; ACP Decisions, Boston, MA, USA., Simon GE; Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA.

Journal Article , 2025

Pragmatic monitoring of emerging efficacy data in randomized controlled trials.

Bangdiwala SI; Population Health Research Institute (PHRI), Faculty of Health Sciences, McMaster University and Hamilton Health Sciences, Hamilton, ON, Canada.; Department of Health Research Methods, Evidence, and Impact, Faculty of Health Sciences, McMaster University, Hamilton, ON, Canada., Yusuf S; Population Health Research Institute (PHRI), Faculty of Health Sciences, McMaster University and Hamilton Health Sciences, Hamilton, ON, Canada.; Department of Health Research Methods, Evidence, and Impact, Faculty of Health Sciences, McMaster University, Hamilton, ON, Canada.; Department of Medicine, Faculty of Health Sciences, McMaster University, Hamilton, ON, Canada.

Journal Article , 2025

A Sponsor's Best Practice and Operating Principles to Manage Data Monitoring Committees.

Birck MM; Safety Surveillance, Novo Nordisk A/S, Copenhagen, Denmark., Rasmussen JS; Safety Surveillance, Novo Nordisk A/S, Copenhagen, Denmark., Helmark IC; Medical & Science, Novo Nordisk A/S, Copenhagen, Denmark., Lollike K; Global Patient Safety, Novo Nordisk A/S, Copenhagen, Søborg, 2860, Denmark. kalo@novonordisk.com.

Journal Article , 2025

Interim Clinical Trial Data: Who Can See What, and When?

Ellenberg SS; Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, 19104, USA. sellenbe@pennmedicine.upenn.edu., Li Y; Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, 19104, USA.

Journal Article; Letter , 2025

Data Monitoring Committee Reports: Telling the Data's Story.

Zeng L; The Biostatistics Center, Milken Institute School of Public Health, The George Washington University, Rockville, USA., Hamasaki T; The Biostatistics Center, Milken Institute School of Public Health, The George Washington University, Rockville, USA.; Department of Biostatistics and Bioinformatics, Milken Institute School of Public Health, The George Washington University, Washington, D.C., USA., Evans SR; The Biostatistics Center, Milken Institute School of Public Health, The George Washington University, Rockville, USA. sevans@bsc.gwu.edu.; Department of Biostatistics and Bioinformatics, Milken Institute School of Public Health, The George Washington University, Washington, D.C., USA. sevans@bsc.gwu.edu.

Journal Article; Review , 2025

Inside the Mind of the DMC: A Review of Principles and Issues with Case Studies.

Ge L; The Biostatistics Center, Milken Institute School of Public Health, The George Washington University, Rockville, MD, USA.; Department of Biostatistics and Bioinformatics, Milken Institute School of Public Health, The George Washington University, Washington, DC, USA., Hamasaki T; The Biostatistics Center, Milken Institute School of Public Health, The George Washington University, Rockville, MD, USA.; Department of Biostatistics and Bioinformatics, Milken Institute School of Public Health, The George Washington University, Washington, DC, USA., Evans SR; The Biostatistics Center, Milken Institute School of Public Health, The George Washington University, Rockville, MD, USA. sevans@bsc.gwu.edu.; Department of Biostatistics and Bioinformatics, Milken Institute School of Public Health, The George Washington University, Washington, DC, USA. sevans@bsc.gwu.edu.

Journal Article; Review , 2025

Ethical Issues Faced by Data Monitoring Committees: Results from an Exploratory Qualitative Study.

Shah SK; Founder's Board Professor of Medical Ethics and the director of the Pediatric Research Ethics and Policy Program at the Ann & Robert H. Lurie Children's Hospital and Northwestern University., Ibrahim A; Program manager at the Ann & Robert H. Lurie Children's Hospital., Hinga A; Social scientist and bioethicist and a postdoctoral researcher at the Kenya Institute of Medical Research-Wellcome Trust Research Programme in Kenya., Vintimilla D; Student at the Chicago School of Psychology., Jones M; Manager of research operations at the Stanley Manne Children's Research Institute at the Ann & Robert H. Lurie Children's Hospital., Rid A; Faculty member and the director of Global Health Ethics at the National Institutes of Health Clinical Center Department of Bioethics and is cross-appointed with the Fogarty International Center., Eckstein L; Bioethicist and program director of CT:IQ, which is hosted by Bellberry, Ltd, a provider of human research ethics services., Kamuya D; Social scientist and bioethicist and the head of the Health Systems and Research Ethics Department at the Kenya Institute of Medical Research-Wellcome Trust Research Programme in Kenya.

Journal Article , 2024

Stakeholders' Perspectives on Current Issues in Data Monitoring Committees.

Cartwright MJ; Parexel International Ltd., Sheffield, UK., Friede T; Department of Medical Statistics, University Medical Center Göttingen, Göttingen, Germany.; DZHK (German Center for Cardiovascular Research), Göttingen, Germany., Lawrence D; Analytics, Novartis Pharma AG, Basel, Switzerland., May E; ICON PLC, Reading, UK.; BioNTech SE, Mainz, Germany., Mütze T; Analytics, Novartis Pharma AG, Basel, Switzerland., Roes K; Radboud University Medical Center, Nijmegen, The Netherlands.

Journal Article; Review , 2024

Training the Next Generation of Data Monitoring Committee Members: An Initiative of the Heart Failure Collaboratory.

Fleming TR; Department of Biostatistics, University of Washington, Seattle, Washington, USA., Wittes J; Wittes LLC, Washington, DC, USA., Fiuzat M; Division of Cardiology, Duke University, Durham, North Carolina, USA. Electronic address: mona.fiuzat@duke.edu., Bristow MR; Division of Cardiology, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA., Rockhold FW; Department of Biostatistics and Bioinformatics, Duke University School of Medicine and Duke Clinical Research Institute, Durham, North Carolina, USA., Connor JT; ConfluenceStat LLC, Cooper City, Florida, USA; University of Central Florida College of Medicine, Orlando, Florida, USA., Saville BR; Adaptix Trials, LLC, Austin, Texas, USA; Vanderbilt University Department of Biostatistics (adjoint faculty), Nashville, Tennessee, USA., Claggett B; Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, Massachusetts, USA., Cavagna I; Inova Schar Heart and Vascular, Fall Church, Virginia, USA., Abraham WT; Division of Cardiovascular Medicine and the Davis Heart and Lung Research Institute, The Ohio State University College of Medicine/Ohio State University Wexner Medical Center, Columbus, Ohio, USA., Cook TD; Biostatistics and Medical Informatics, University of Wisconsin, Madison, Wisconsin, USA., Lindenfeld J; Division of Cardiovascular Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA., O'Connor C; Inova Schar Heart and Vascular, Fall Church, Virginia, USA., DeMets DL; Department of Biostatistics and Medical Informatics, University of Wisconsin, Madison, Wisconsin, USA.

Heart Failure Collaboratory

Journal Article; Review , 2024

Ethical preparedness of data monitoring committees (DMCs) to oversee international clinical trials: a qualitative descriptive study.

Hinga A; Health Systems and Research Ethics Department, KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya Ahinga@kemri-wellcome.org., Ibrahim A; Mary Ann & J. Milburn Smith Child Health Outcomes, Research, and Evaluation Center, Stanley Manne Children's Research Institute, Ann & Robert H Lurie Children's Hospital, Chicago, Illinois, USA., Vintimilla D; Chicago Department of Public Health, Chicago, Illinois, USA., Jones M; Mary Ann & J. Milburn Smith Child Health Outcomes, Research, and Evaluation Center, Stanley Manne Children's Research Institute, Ann & Robert H Lurie Children's Hospital, Chicago, Illinois, USA., Eckstein L; School of Law, University of Tasmania, Hobart, Tasmania, Australia., Rid A; Department of Bioethics, The Clinical Center & Division of International Science Policy, Planning and Evaluation, Fogarty International Center, National Institutes of Health, Bethesda, Maryland, USA., Shah SK; Mary Ann & J. Milburn Smith Child Health Outcomes, Research, and Evaluation Center, Stanley Manne Children's Research Institute, Ann & Robert H Lurie Children's Hospital, Chicago, Illinois, USA.; Department of Pediatrics, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA., Kamuya D; Health Systems and Research Ethics Department, KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya.; Nuffield Department of Clinical Medicine, Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, UK.

Journal Article , 2024

Data Safety Monitoring Boards: Overview of Structure and Role in Spinal Cord Injury Studies.

Blight AR; University of Plymouth, United Kingdom., Guest JD; School of Medicine, University of Miami, Miami, Florida., Hamer J; DP Clinical Inc., Rockville, Maryland., Hsieh JTC; Wings for Life, Toronto, Ontario., Jones L; Boulder, Colorado., Magnuson DSK; University of Louisville, Louisville, Kentucky., Pfleeger K; AbbVie Inc., North Chicago, Illinois.

Journal Article; Review , 2024

A Proposed Confidence Ellipse Approach for Benefit-Risk Assessment in Clinical Trials.

Zhang Y; Department of Biostatistics and Bioinformatics, Duke University School of Medicine, NC, Durham, USA. yinuo.zhang@duke.edu., Zhang X; Clinical Research Institute, Institute of Advanced Clinical Medicine, Peking University, Beijing, China., Wang P; Department of Biostatistics and Bioinformatics, Duke University School of Medicine, NC, Durham, USA., Wu Y; Clinical Research Institute, Institute of Advanced Clinical Medicine, Peking University, Beijing, China., Chow SC; Department of Biostatistics and Bioinformatics, Duke University School of Medicine, NC, Durham, USA.

Journal Article , 2025

Shedding light on data monitoring committee charters on ClinicalTrials.gov.

Fine AM; National Center for Biotechnology Information, National Library of Medicine, National Institutes of Health, Bethesda, MD, USA., Golfinopoulos E; National Center for Biotechnology Information, National Library of Medicine, National Institutes of Health, Bethesda, MD, USA., Tse T; National Center for Biotechnology Information, National Library of Medicine, National Institutes of Health, Bethesda, MD, USA.

Letter; Research Support, N.I.H., Intramural; Comment , 2024

Training New DMC Members: A Call to Action.

Rockhold F; Duke University Medical Center, Durham, USA. frank.rockhold@duke.edu.; Duke Clinical Research Institute, Durham, USA. frank.rockhold@duke.edu., Mahaffey K; Stanford University Medical School, Stanford, USA., DeMets D; Unversity of Wisconsin, Madison, USA.

Journal Article , 2024

Data monitoring committees in pediatric randomized controlled trials registered in ClinicalTrials.gov.

Machado T; Laboratory of Clinical Pharmacology and Therapeutics, Faculdade de Medicina, Universidade de Lisboa, Lisbon, Portugal.; Instituto de Medicina Molecular João Lobo Antunes, Lisbon, Portugal., Mainoli B; Laboratory of Clinical Pharmacology and Therapeutics, Faculdade de Medicina, Universidade de Lisboa, Lisbon, Portugal.; Instituto de Medicina Molecular João Lobo Antunes, Lisbon, Portugal.; Clinical Research Unit, Research Center of IPO Porto (CI-IPOP), Porto, Portugal., Caldeira D; Laboratory of Clinical Pharmacology and Therapeutics, Faculdade de Medicina, Universidade de Lisboa, Lisbon, Portugal.; Instituto de Medicina Molecular João Lobo Antunes, Lisbon, Portugal., Ferreira JJ; Laboratory of Clinical Pharmacology and Therapeutics, Faculdade de Medicina, Universidade de Lisboa, Lisbon, Portugal.; Instituto de Medicina Molecular João Lobo Antunes, Lisbon, Portugal.; Campus Neurológico Sénior (CNS), Torres Vedras, Portugal., Fernandes RM; Laboratory of Clinical Pharmacology and Therapeutics, Faculdade de Medicina, Universidade de Lisboa, Lisbon, Portugal.; Instituto de Medicina Molecular João Lobo Antunes, Lisbon, Portugal.; Department of Pediatrics, Santa Maria Hospital, Centro Hospitalar Universitário Lisboa Norte, Lisbon, Portugal.

Journal Article , 2023

Bringing data monitoring committee charters into the sunlight.

DeMets DL; University of Wisconsin-Madison, Madison, WI, USA., Zarin DA; The MRCT Center of Brigham and Women's Hospital and Harvard, Cambridge, MA, USA., Rockhold F; Duke Clinical Research Institute/Duke University, Durham, NC, USA., Ellenberg SS; University of Pennsylvania, Philadelphia, PA, USA., Fleming T; University of Washington, Seattle, WA, USA., Wittes J; Wittes LLC, Washington, DC, USA.

Journal Article , 2023

The Data Monitoring Committee: A Collective or a Collection?

Wittes J; Wittes LLC, Washington, DC, USA. Janet@Wittesllc.com., Fleming T; University of Washington, Seattle, WA, USA., DeMets D; University of Wisconsin-Madison, Madison, WI, USA., Ellenberg S; University of Pennsylvania, Philadelphia, PA, USA., Gerstein H; Population Health Research Institute and Department of Medicine, McMaster University and Hamilton Health Sciences, Hamilton, Canada., Pfeffer M; Harvard Medical School and Brigham and Women's Hospital, Boston, MA, USA., Rockhold F; Duke University Medical Center and The Duke Clinical Research Institute, Durham, NC, USA., Yusuf S; Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, Canada., Hennekens C; Florida Atlantic University, Boca Raton, FL, USA.

Journal Article , 2023

Commentary on DeMets et al: The need for greater transparency regarding data monitoring committee charters.

Shah SK; Department of Pediatrics, Ann and Robert H Lurie Children's Hospital of Chicago, Chicago, IL, USA.; Department of Pediatrics, Northwestern University Feinberg School of Medicine, Chicago, IL, USA., Eckstein L; Department of Law, University of Tasmania, Hobart, TAS, Australia., Ibrahim A; Smith Child Health Outcomes, Research and Evaluation Center, Ann and Robert H Lurie Children's Hospital of Chicago, Chicago, IL, USA.

Journal Article; Research Support, Non-U.S. Gov't; Comment , 2023

DMC reports in the 21st century: towards better tools for decision-making.

Vandemeulebroecke M; Novartis Pharma AG, Basel, Switzerland., Baillie M; Novartis Pharma AG, Basel, Switzerland., Mirshani A; Novartis Institutes of Biomedical Research, Cambridge, USA., Lesaffre E; L-Biostat, KU Leuven, Leuven, Belgium. emmanuel.lesaffre@kuleuven.be.

Journal Article , 2023