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

In: Data Monitoring in Clinical Trials

Author

Listed:
  • David L. DeMets

    (University of Wisconsin, Department of Biostatistics and Medical Informatics)

  • George W. Williams

    (Amgen Inc.)

  • Byron W. Brown Jr.

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.

Suggested Citation

  • David L. DeMets & George W. Williams & Byron W. Brown Jr., 2006. "The Nocturnal Oxygen Therapy Trial Data Monitoring Experience: Problem With Reporting Lags," Springer Books, in: David L. DeMets & Curt D. Furberg & Lawrence M. Friedman (ed.), Data Monitoring in Clinical Trials, chapter 0, pages 292-301, Springer.
    • Handle: RePEc:spr:sprchp:978-0-387-30107-5_28
    DOI: 10.1007/0-387-30107-0_28
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