title: Enhancing the Scientific Integrity and Safety of Clinical Trials: Recommendations for Data Monitoring Committees.
authors.affiliation: Department of Emergency Medicine, Harbor-UCLA Medical Center, Torrance, California2Berry Consultants LLC, Austin, Texas.
authors.forename: Roger J
authors.initials: RJ
authors.lastname: Lewis
authors.affiliation: Office of Medical Policy, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland4Office of the Clinical Director, National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland.
authors.forename: Karim A
authors.initials: KA
authors.lastname: Calis
authors.affiliation: Department of Biostatistics and Medical Informatics, University of Wisconsin, Madison.
authors.forename: David L
authors.initials: DL
authors.lastname: DeMets
mesh_terms: D026661:Clinical Trials Data Monitoring Committees; D002986:Clinical Trials as Topic / Q000941:ethics* / Q000592:standards; D061214:Patient Safety; D016896:Treatment Outcome