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Study 329 : Why is it so important? Therapeutics Initiative (University of British Columbia)

Description

Therapeutics Letter 101 explores the reanalysis of Study 329 by the Restoring Invisibile and Abandoned Trials (RIAT) Initiative. Conclusions: Independent analysis of Study 329 demonstrated serious harms and a lack of efficacy for acute and longer-term use of paroxetine and imipramine for adolescents with major depression. This example of the RIAT initiative reveals that the current methods of trial conduct, analysis and publication are unacceptable. Published conclusions about efficacy and safety of drugs without independent analysis cannot be accepted as trustworthy. It is essential that primary trial data and protocols for all clinical trials be made available for independent analysis.

Item Metadata

Title
Study 329 : Why is it so important?
Alternate Title
Therapeutics Letter 101
Creator
Therapeutics Initiative (University of British Columbia)
Date Issued
2016-08
Description
Therapeutics Letter 101 explores the reanalysis of Study 329 by the Restoring Invisibile and Abandoned Trials (RIAT) Initiative. Conclusions: Independent analysis of Study 329 demonstrated serious harms and a lack of efficacy for acute and longer-term use of paroxetine and imipramine for adolescents with major depression. This example of the RIAT initiative reveals that the current methods of trial conduct, analysis and publication are unacceptable. Published conclusions about efficacy and safety of drugs without independent analysis cannot be accepted as trustworthy. It is essential that primary trial data and protocols for all clinical trials be made available for independent analysis.
Subject
Adolescent; Antidepressive Agents; Depression; Depressive Disorder, Major; Imipramime; Paroxetine; Publication Bias
Genre
Other
Type
Text
Language
eng
Notes
The UBC TI is funded by the BC Ministry of Health to provide evidence-based information about drug therapy. We neither formulate nor adjudicate provincial drug policies.
Date Available
2023-06-20
Provider
Vancouver : University of British Columbia Library
Rights
Attribution-NonCommercial-NoDerivatives 4.0 International
DOI
10.14288/1.0433680
URI
http://hdl.handle.net/2429/85090
Affiliation
Medicine, Faculty of; Anesthesiology, Pharmacology and Therapeutics, Department of
Peer Review Status
Reviewed
Scholarly Level
Faculty; Researcher
Rights URI
http://creativecommons.org/licenses/by-nc-nd/4.0/
Aggregated Source Repository
DSpace

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Attribution-NonCommercial-NoDerivatives 4.0 International