Jan 15, 2011

The importance of publishing negative trials

Mankind history is written by winners. Similarly, the history of psychopharmacology is written by winning drugs. And yet, there is little we can learn from victories and much to be learnt from failure.

Hence, the problem of publication bias, where positive studies are considered by editors – and,
probably, by many scientific readers – as particularly appealing whilst negative studies are seen as dull and irrelevant, has to be considered not only from a legal perspective but also from an academic one. Nowadays, publication bias constitutes a solid barrier not only to our pharmacological practice but, specially, to clinical trials design improvement.
To begin with, lack of publication of clinical trials with negative outcomes is depriving us from improving our clinical practice by learning what not to do – i.e. wrong titration or dose – and who not to treat – by allowing us to identify a nonresponder profile. Moreover, and maybe worse than that, publication bias is depriving us to learn on what went wrong on a certain trial and, hence, improving our clinical trial designing. This is particularly important in the case of negative studies of drugs that have latter received agencies approval because of other positive studies and in the case of failed studies – where a design problem blunted outcomes both of the experimental drug and the comparator. Hence, the distinction between negative and failed studies is important and, to make it possible, three-arm designs (including placebo, an active comparator and the experimental drug) should be priorized (1) and subsequently published regardless of outcome.

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