captain ben and his crew…

Posted on Sunday 15 May 2016

There are times when being wrong is just fine. When I first read about Ben Goldacre‘s COMPare Project, I didn’t think it would have much of an impact. What he was proposing to do was put together an army of medical students who would look over Clinical Trial papers and when they found one that didn’t follow the a priori Protocol, they’d start writing letters to the Journal, calling it "outcome switching." While I certainly agree with the sentiment, I thought his campaign was too simplistic – more parrying than combat…
Retraction Watch
by Alison McCook
May 15, 2016

A major medical journal has updated its instructions to authors, now requiring that they publish protocols of clinical trials, along with any changes made along the way.

We learned of this change via the COMPare project, which has been tracking trial protocol changes in major medical journals — and been critical of the Annals of Internal Medicine‘s response to those changes. However, Darren Taichman, the executive deputy editor of the journal, told us the journal’s decision to publish trial protocols was a long time coming…
    This change was something we planned prior to COMPARE and were intending to implement with an update of our online journal that is in process. However, the barrier COMPARE encountered in obtaining a protocol for one of the studies in their audit prompted us to implement it earlier…
Read the whole thing. It’s the real deal – a success that could be bigger than Ben’s AllTrials campaign. So I guess that one moral of the story is Don’t bet against Ben Goldacre. His TED talk was a landmark as was his AllTrials campaign. He seems to have the gift of both method and timing – something of a swashbuckler in an age of plodders.

While I still believe that Data Transparency is the ultimate goal to combat the rampant corruption, I realized when we were writing our RIAT paper that we needed a preventive strategy as well – something to head off the deceit in the first place. In the original Paxil Study 329, the Celexa Study in my last post [this tawdry era…], and for that matter, the overwhelming majority of the distorted RCTs I’ve looked at over the years, deviating from the a priori Protocol and/or the Statistical Analysis Plan to find something to call significant has been a ubiquitous practice, and the standard means for turning all those sow’s ears into silk purses.

It’s simple, up front, something that happens at the level of the journal publications where it needs to happen, and he’s brought it off in a major journal. So my hat’s off to Captain Ben and his crew…
  1.  
    Susan Molchan
    May 16, 2016 | 8:50 AM
     

    COMPare is a great project, and Ben and company there post they are looking for others to canvas their own specialty’s journals (they look at the top 5 medical journals). I’d be interested in helping (w/ JAMA Psych, AJP, J Clin Psych, J Amer Acad Child & Adol, what else?) if there were others interested too

  2.  
    James OBrien, M.D.
    May 19, 2016 | 1:19 AM
     

    It’s a start, but it will be whack a mole. If the major journals come around to this, look for even more junk in the lower tier publications.

    I wouldn’t hold my breath about J AACAP given recent history.

    I’m glad some of this energy is being directed away from pharma to the academic-publishing complex, which has far higher margins and is increasingly a repository for academic mediocrity. Pearson lately has been pushing all my buttons, as they are not only heavily involved in compulsory monopolies like MOC and Common Core and textbooks. Another Ayn Rand novel villain, IMHO.

    http://thestatetimes.com/2013/11/20/the-pearson-monopoly/

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