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Letters | August 27, 2008

Guest Authorship, Mortality Reporting, and Integrity in Rofecoxib Studies—Reply

Bruce M. Psaty, MD, PhD; Richard A. Kronmal, PhD
JAMA. 2008;300(8):900-906. doi:10.1001/jama.300.8.904-b.
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In Reply: Drs Johnson and Lassere emphasize the importance of prespecified analyses in the reporting and interpretation of randomized clinical trials. The protocol for a trial serves as the centerpiece, and its analysis plan needs to specify not only the type and method of analysis but the efficacy and safety outcomes as well. Information about amendments, their timing, and the rationales should become part of the protocol. Ideally, this full protocol should be available to reviewers and editors when the manuscript for the corresponding trial is submitted to a journal. As Johnson and Lassere point out, the FDA Amendments Act requirement to post “the full protocol or such information on the protocol for the trial as may be necessary to help to evaluate the results of the trial”1 may prove especially useful.

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Country-Specific Mortality and Growth Failure in Infancy and Yound Children and Association With Material Stature

Use interactive graphics and maps to view and sort country-specific infant and early dhildhood mortality and growth failure data and their association with maternal

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August 27, 2008
Guest Authorship, Mortality Reporting, and Integrity in Rofecoxib Studies
Kent R. Johnson, MD; Marissa N. D. Lassere, MBBS, PhD
JAMA. 2008;300(8):900-906. doi:10.1001/jama.300.8.900-a.
August 27, 2008
Guest Authorship, Mortality Reporting, and Integrity in Rofecoxib Studies
Garret A. FitzGerald, MD
JAMA. 2008;300(8):900-906. doi:10.1001/jama.300.8.900-b.
August 27, 2008
Guest Authorship, Mortality Reporting, and Integrity in Rofecoxib Studies
Carlo Patrono, MD
JAMA. 2008;300(8):900-906. doi:10.1001/jama.300.8.901-a.
August 27, 2008
Guest Authorship, Mortality Reporting, and Integrity in Rofecoxib Studies
Christopher J. Hawkey, DM
JAMA. 2008;300(8):900-906. doi:10.1001/jama.300.8.901-b.
August 27, 2008
Guest Authorship, Mortality Reporting, and Integrity in Rofecoxib Studies
Steven Ferris, PhD; Douglas Galasko, MD; Louis Kirby, MD
JAMA. 2008;300(8):900-906. doi:10.1001/jama.300.8.901-c.
August 27, 2008
Guest Authorship, Mortality Reporting, and Integrity in Rofecoxib Studies
Richard Balon, MD
JAMA. 2008;300(8):900-906. doi:10.1001/jama.300.8.902-a.
August 27, 2008
Guest Authorship, Mortality Reporting, and Integrity in Rofecoxib Studies
Serban-Dan Costa, MD, PhD
JAMA. 2008;300(8):900-906. doi:10.1001/jama.300.8.902-b.
August 27, 2008
Guest Authorship, Mortality Reporting, and Integrity in Rofecoxib Studies
Hervé Maisonneuve, MD
JAMA. 2008;300(8):900-906. doi:10.1001/jama.300.8.903-a.
August 27, 2008
Guest Authorship, Mortality Reporting, and Integrity in Rofecoxib Studies
Hean T. Ong, MBBS; Jin S. Cheah, MBBS
JAMA. 2008;300(8):900-906. doi:10.1001/jama.300.8.903-b.
August 27, 2008
Guest Authorship, Mortality Reporting, and Integrity in Rofecoxib Studies
Peter A. Lachenbruch, PhD; Ronald Wasserstein, PhD
JAMA. 2008;300(8):900-906. doi:10.1001/jama.300.8.904-a.
August 27, 2008
Guest Authorship, Mortality Reporting, and Integrity in Rofecoxib Studies—Reply
Joseph S. Ross, MD, MHS; David S. Egilman, MD, MPH; Harlan M. Krumholz, MD, SM
JAMA. 2008;300(8):900-906. doi:10.1001/jama.300.8.904-c.
August 27, 2008
Guest Authorship, Mortality Reporting, and Integrity in Rofecoxib Studies—Reply
Catherine D. DeAngelis, MD, MPH; Phil B. Fontanarosa, MD, MBA
JAMA. 2008;300(8):900-906. doi:10.1001/jama.300.8.905.
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