Skip to main content
Duke University Libraries
DukeSpace Scholarship by Duke Authors
  • Login
  • Ask
  • Menu
  • Login
  • Ask a Librarian
  • Search & Find
  • Using the Library
  • Research Support
  • Course Support
  • Libraries
  • About
View Item 
  •   DukeSpace
  • Duke Scholarly Works
  • Scholarly Articles
  • View Item
  •   DukeSpace
  • Duke Scholarly Works
  • Scholarly Articles
  • View Item
JavaScript is disabled for your browser. Some features of this site may not work without it.

Issues in regulatory guidelines for data monitoring committees.

Thumbnail
View / Download
1.9 Mb
Date
2004
Authors
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
Show More
(19 total)
Repository Usage Stats
198
views
458
downloads
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.
Type
Journal article
Subject
Clinical Trials Data Monitoring Committees
Clinical Trials as Topic
Guidelines as Topic
Humans
Research Support as Topic
United States
United States Food and Drug Administration
Permalink
https://hdl.handle.net/10161/11006
Published Version (Please cite this version)
10.1191/1740774504cn019xx
Publication Info
DeMets, David; Califf, Robert; Dixon, Dennis; Ellenberg, Susan; Fleming, Thomas; Held, Peter; ... Whitley, Richard (2004). Issues in regulatory guidelines for data monitoring committees. Clin Trials, 1(2). pp. 162-169. 10.1191/1740774504cn019xx. Retrieved from https://hdl.handle.net/10161/11006.
This is constructed from limited available data and may be imprecise. To cite this article, please review & use the official citation provided by the journal.
Collections
  • Scholarly Articles
More Info
Show full item record

Scholars@Duke

Califf

Robert M. Califf

Adjunct Professor of Medicine
Robert Califf, MD MACC, is an Adjunct Professor of Medicine in the Division of Cardiology and remains a practicing cardiologist. Dr. Califf was the Commissioner of Food and Drugs in 2016-2017 and Deputy Commissioner for Medical Products and Tobacco from February 2015 until his appointment as Commissioner in February 2016. Prior to joining the FDA, Dr. Califf was a professor of medicine and vice chancellor for clinical and translational research at Duke University. He also served as direc
This author no longer has a Scholars@Duke profile, so the information shown here reflects their Duke status at the time this item was deposited.
Rockhold

Frank Wesley Rockhold

Professor of Biostatistics & Bioinformatics
Frank is a full time Professor of Biostatistics and Bioinformatics and Faculty Director for Biostatistics at Duke University Medical Center, Affiliate Professor of Biostatistics at Virginia Commonwealth University, and Strategic Consultant at Hunter Rockhold, Inc.  His 40+-year career includes senior research positions at Lilly, Merck, and GlaxoSmithKline, where he retired as Chief Safety Officer and Senior Vice President of Global Clinical Safety and Pharmacovigilance.  He h
Alphabetical list of authors with Scholars@Duke profiles.
Open Access

Articles written by Duke faculty are made available through the campus open access policy. For more information see: Duke Open Access Policy

Rights for Collection: Scholarly Articles


Works are deposited here by their authors, and represent their research and opinions, not that of Duke University. Some materials and descriptions may include offensive content. More info

Make Your Work Available Here

How to Deposit

Browse

All of DukeSpaceCommunities & CollectionsAuthorsTitlesTypesBy Issue DateDepartmentsAffiliations of Duke Author(s)SubjectsBy Submit DateThis CollectionAuthorsTitlesTypesBy Issue DateDepartmentsAffiliations of Duke Author(s)SubjectsBy Submit Date

My Account

LoginRegister

Statistics

View Usage Statistics
Duke University Libraries

Contact Us

411 Chapel Drive
Durham, NC 27708
(919) 660-5870
Perkins Library Service Desk

Digital Repositories at Duke

  • Report a problem with the repositories
  • About digital repositories at Duke
  • Accessibility Policy
  • Deaccession and DMCA Takedown Policy

TwitterFacebookYouTubeFlickrInstagramBlogs

Sign Up for Our Newsletter
  • Re-use & Attribution / Privacy
  • Harmful Language Statement
  • Support the Libraries
Duke University