Clinical trial data – is transparency too much to ask?

A new survey has found that many medical publication professionals are aware of unpublished negative data from clinical trials.  In fact, 58% of respondents were aware of negative data from clinical trials remaining unpublished.

It is easy to understand why companies, scientists, and even publications would not wish to publish negative data.  Firstly, it opens the work up to greater criticism and scrutiny.  But with the increasing numbers of late stage drug failures (up 29% from last year), isn’t greater scrutiny a good thing, especially in the earlier stages of drug development?  After all, the number one reason that drugs fail in late stage clinical trials is that they fail to show efficacy over the placebo.  If greater scrutiny by academic peers (rather than in-house scientists who are often too close to the problem to see the forest from the trees) leads to the discovery of inefficacy at an earlier stage, aren’t the savings in time and development costs worth the extra criticism?

Secondly, negative data doesn’t tell a nice, neat story with a happy ending.  Medical research is never as tidy as journal publications would have us believe, and the whole story is often convoluted and full of possibilities for misinterpretation.  The concern is that somewhere in the twists and turns, the reader will lose the plot.  But there was a time when negative data was considered useful and important, not something to be swept under the rug during the tidying process.  Publications should seek to foster transparency in the reporting of clinical trials, to require the whole story, good and bad.

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