The reanalysis of Study 329 illustrates the necessity of making primary trial data and protocols available to increase the rigour of the evidence base.
Access to primary data from trials has important implications for both clinical practice and research, including that published conclusions about efficacy and safety should not be read as authoritative.
Jon Jueridini and colleagues have reanalysed SmithKline Beecham’ infamous Study 329 (published by Keller and colleagues in 2001), the primary objective of which was to compare the efficacy and safety of paroxetine and imipramine with placebo in the treatment of adolescents with unipolar major depression.
The reanalysis under the restoring invisible and abandoned trials (RIAT) initiative was done to see whether access to and reanalysis of a full dataset from a randomised controlled trial would have clinically relevant implications for evidence based medicine.
Their analysis finds that neither paroxetine nor high dose imipramine showed efficacy for major depression in adolescents, and there was an increase in harms with both drugs.
More on Study 329 from The BMJ
- Study 329, doi.org/10.1136/bmj.h4973, 17 September 2015.
- Restoring Study 329: efficacy and harms of paroxetine and imipramine in treatment of major depression in adolescence, doi.org/10.1136/bmj.h4320, 16 September 2015.
- No correction, no retraction, no apology, no comment: paroxetine trial reanalysis raises questions about institutional responsibility, doi.org/10.1136/bmj.h4629, 16 September 2015.
- Restoring Study 329: efficacy and harms of paroxetine and imipramine in treatment of major depression in adolescence, doi.org/10.1136/bmj.h4320, 16 September 2015.
- Restoring invisible and abandoned trials: a call for people to publish the findings, doi.org/10.1136/bmj.f2865, June 28, 2013.
More on Study 329 from Dr David Healy’s blog
- The Ghost of Research Future.
- Study 329: Big Risk.
- Study 329: BMJ Transparency.
- Study 329: 50 Shades of Gray.
- Study 329: Conflicts of Interest.
- Study 329 in Japan.
- Study 329: By the Standards of the Time.
- Study 329: Minions No Longer.
- Study 329: Data Wars.
- Study 329: MK, HK, SK, GSK & History.
- Study 329: MK, HK, SK and GSK.
- Study 329.
- Study 329: The Data.
- The Troubled Life of Study 329: Consequences of Failure to Retract.
- Original Study 329 Team.
- Study329.org: Science with a Conscience.
- Study 329: The Timelines.
- Study329.org: The Panorama Files.
- A Milestone in the Battle for Truth in Drug Safety.
More on Study 329
- Initial – 1st – Study 329, jaacap, July 2001.
- Restoring Study 329, website.
- About : Documenting Seroxat : An Epic Medical Scandal, truthman30/.
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