Issues in regulatory guidelines for data monitoring committees.

David DeMets, Robert Califf, Dennis Dixon, Susan Ellenberg, Thomas Fleming, Peter Held, Desmond Julian, Richard Kaplan, Robert Levine, James Neaton, Milton Packer, Stuart Pocock, Frank Rockhold, Belinda Seto, Jay Siegel, Steve Snapinn, David Stump, Robert Temple, Richard Whitley

Research output: Contribution to journalArticle

13 Citations (Scopus)

Abstract

As clinical trials have emerged as the major research method for evaluating new interventions, the process for monitoring intervention safety and benefit has also evolved. The Data Monitoring Committee (DMC) has become the standard approach to implement this responsibility for many Phase III trials. Recent draft guidelines on the operation of DMCs by the Food and Drug Administration (FDA) have raised issues that need further clarification or discussion, especially for industry sponsored trials. These include, the time when DMCs are needed, the role of the independent statistician to support the DMC, and sponsor participation at DMC meetings. This paper provides an overview of these issues, based on the discussions at the January, 2003 workshop sponsored by Duke Clinical Research Institute.

Original languageEnglish (US)
Pages (from-to)162-169
Number of pages8
JournalClinical trials (London, England)
Volume1
Issue number2
StatePublished - 2004

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Clinical Trials Data Monitoring Committees
Guidelines
United States Food and Drug Administration
Industry
Clinical Trials
Safety
Education
Research

ASJC Scopus subject areas

  • Medicine(all)

Cite this

DeMets, D., Califf, R., Dixon, D., Ellenberg, S., Fleming, T., Held, P., ... Whitley, R. (2004). Issues in regulatory guidelines for data monitoring committees. Clinical trials (London, England), 1(2), 162-169.

Issues in regulatory guidelines for data monitoring committees. / DeMets, David; Califf, Robert; Dixon, Dennis; Ellenberg, Susan; Fleming, Thomas; Held, Peter; Julian, Desmond; Kaplan, Richard; Levine, Robert; Neaton, James; Packer, Milton; Pocock, Stuart; Rockhold, Frank; Seto, Belinda; Siegel, Jay; Snapinn, Steve; Stump, David; Temple, Robert; Whitley, Richard.

In: Clinical trials (London, England), Vol. 1, No. 2, 2004, p. 162-169.

Research output: Contribution to journalArticle

DeMets, D, Califf, R, Dixon, D, Ellenberg, S, Fleming, T, Held, P, Julian, D, Kaplan, R, Levine, R, Neaton, J, Packer, M, Pocock, S, Rockhold, F, Seto, B, Siegel, J, Snapinn, S, Stump, D, Temple, R & Whitley, R 2004, 'Issues in regulatory guidelines for data monitoring committees.', Clinical trials (London, England), vol. 1, no. 2, pp. 162-169.
DeMets D, Califf R, Dixon D, Ellenberg S, Fleming T, Held P et al. Issues in regulatory guidelines for data monitoring committees. Clinical trials (London, England). 2004;1(2):162-169.
DeMets, David ; Califf, Robert ; Dixon, Dennis ; Ellenberg, Susan ; Fleming, Thomas ; Held, Peter ; Julian, Desmond ; Kaplan, Richard ; Levine, Robert ; Neaton, James ; Packer, Milton ; Pocock, Stuart ; Rockhold, Frank ; Seto, Belinda ; Siegel, Jay ; Snapinn, Steve ; Stump, David ; Temple, Robert ; Whitley, Richard. / Issues in regulatory guidelines for data monitoring committees. In: Clinical trials (London, England). 2004 ; Vol. 1, No. 2. pp. 162-169.
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