The Nocturnal Oxygen Therapy Trial Data Monitoring Experience: Problem With Reporting Lags

David L. DeMets, George W. Williams and Byron W. Brown
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David L. DeMets: University of Wisconsin, Department of Biostatistics and Medical Informatics
George W. Williams: Amgen Inc.

Chapter Case 22 in Data Monitoring in Clinical Trials, 2006, pp 292-301 from Springer

Abstract: Abstract The Nocturnal Oxygen Therapy Trial (NOTT) was a randomized controlled trial designed to evaluate the role of continuous oxygen compared to only nocturnal use for patients with advanced chronic obstructive pulmonary disease. The data monitoring committee for the NOTT had to consider issues of multiple outcomes, extension of patient recruitment, and problems with reporting lags in key outcome data. While statistical methods are very useful, they do not address all of the issues that must be considered. The data monitoring committee had to be alert to unanticipated problems and react accordingly.

Keywords: Chronic Obstructive Pulmonary Disease; Chronic Obstructive Pulmonary Disease Patient; Data Monitoring Committee; Nocturnal Hypoxemia; Continuous Oxygen (search for similar items in EconPapers)
Date: 2006
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DOI: 10.1007/0-387-30107-0_28

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