On bitopertin and sharing data from clinical trials

While modern antipsychotics are doing an OK job improving the positive symptoms of schizophrenia – such as auditory hallucinations or fixed delusional ideas – there is a lot left to be desired in term of how these medications – or any psychotropics for that matter – work against negative symptoms. colorful-pillsThe negative symptoms of schizophrenia, including deficits in a variety of mental functions such as will power, ability to enjoy things, express emotions, or associate with others, have been an elusive target from a treatment perspective. In other words, available medications for schizophrenia might help a patient deal with “the voices,” but, because they do not also improve that patient’s negative symptoms, his ability to return to a meaningful and productive life is not substantially helped.

A promising new medication for negative symptoms — almost

Not surprisingly, any intervention that promises to improve negative symptoms makes the news. This was exactly what happened with bitopertin, a new Roche medication aimed at negative symptoms, which generated enough enthusiasm during its preliminary testing (Phase I and II clinical trials) to move to Phase III trials.

So, one wonders, why didn’t a brand new bitopertin study (ClinicalTrials.gov identifier NCT00616798), with a solid design and impressive action on negative symptoms get any attention – from the media, psychiatrist gurus, patient’s advocates, anyone? The study, which just came out in the flagship psychiatric journal (JAMA Psychiatry) generated no press/media coverage that I am aware off.

Actually, this rather surprising silent treatment is not an accident.

It turns out that this study has been preempted by a press announcement that Roche made this last January stating that  bitopertin did not hold up to its promise following its Phase III testing.  Meaning that… the just published JAMA Psychiatry study — the very study which generated enough enthusiasm to justify the seemingly well-deserved promotion bitopertin received further down the pipeline — is old, outdated news.

To summarize: on one hand, great positive results from a just published study, which, as it turns out, are actually quite old. On the other hand, negative results in Phase III testing, according to a news conference, but no publications to date.

The result: bitopertin is at the center of what is essentially a skewed and likely misleading state of affairs – at least from the point of view of official scientific validation via publication in peer reviewed journals.

How did we get here?

It seems that this bitopertin situation is the predictable result of a series of unfortunate events including:

  1. delays in reporting NCT00616798 study results : the original study, according to the official clinicaltrials.gov data, was completed in February 2010, more than 3 1/2 years prior to submission for  publication (original submission date August 30, 2013)
  2. an extremely lengthy peer review process: only a bit shy of 1/2 year: the original submission date was August 30, 2013; final revision received January 24, 2014; accepted January 24, 2014.
  3. No shared public data for any of the relevant studies that have been completed.

There is a fairly straightforward solution to prevent such complications: opening up the data from clinical trials to the public.alltrials_basic_logo2 Europe is already  pursuing an initiative to make reporting of all clinical trials data mandatory. This is an important step forward. But real progress will not occur unless and until patient level data is made available to the general public as close in time as possible to the date of data collection completion. Adrian Preda, M.D.



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