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Barbui C, Bighelli I. Regulatory science in Europe: the case of schizophrenia trials. Lancet . 2013 Jun 20 ; PubMed Abstract

Comments on Paper and Primary News
Comment by:  Stefan Leucht
Submitted 8 July 2013 Posted 8 July 2013

In their Lancet paper, Barbui and Bighelli criticize the current position of the European Medicines Agency (EMA), which does not ask pharmaceutical companies to submit all conducted trials and does not require trials to be registered in an international registry. The decision to install registers such as for the recording of clinical trials before their start was a major step forward in the combat of publication bias. So in my opinion, the EMA’s current position is a step backward.

I am more skeptical about the other major point made by the authors—that placebo-controlled trials should no longer be necessary for antipsychotic drugs. Despite all the problematic ethical issues with using placebo in schizophrenia, I think placebo control is still necessary. The most recent antipsychotics only yielded effect sizes of around 0.30-0.40 compared to placebo, similar to the effects of antidepressants compared to placebo in major depressive disorder. These differences are so small it could well be that both...  Read more

View all comments by Stefan Leucht

Comment by:  Wolfgang Fleischhacker
Submitted 3 December 2013 Posted 3 December 2013

The European Medicines Agency (EMA) and Schizophrenia Trials
In their critique of the EMA´s guidance for clinical trials in patients with schizophrenia, Drs. Barbui and Bighelli highlight some very pertinent points, such as that it should be mandatory for a sponsor to provide information on all clinical trials that have been performed and that all trials should be registered in an international repository of study protocols. However, they make a number of suggestions that appear problematic and curious.

First, they note that in a three-arm study, the experimental compound should not only be superior to placebo but also not inferior to an active comparator. Given that non-inferiority trials require a considerably larger number of patients (Fleischhacker et al., 2003), this would significantly enhance the cost of such studies and prolong the duration of innovative drug development. Second, the authors’ assumption that a non-inferiority trial tests “whether a new product is not unacceptably worse than a reference...  Read more

View all comments by Wolfgang Fleischhacker
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