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Pharma still not transparent about trial data, says BMJ

Companies under-reporting data from their clinical trials

Pharma companies are still under-reporting data from the clinical trials they undertake despite efforts to boost transparency, according to a series of articles published in the British Medical Journal.

"Missing data about harm in trials can harm patients, and incomplete data about benefit can lead to futile costs to health systems," according to an editorial in the journal authored by BMJ staffers Richard Lehman and Elizabeth Loder.

There has been concern that pharmaceutical firms may be selectively reporting data from studies for years, and a few years back this led to regulatory requirements for publication, including the FDA Amendments Act of 2007 which mandated publication of summary results on the clinicaltrials.gov registry within a year of completing a trial.

Despite this mandate - and public commitments to adhere to it from many of the top pharma companies - another study reported in the BMJ found that more than half of the trials uploaded to the registry remain incomplete after 30 months.

"When the word 'mandatory' turns out to mandate so little, the need for stronger mechanisms of enforcement becomes very clear," according to the BMJ editorial.

Another article in the edition looks at the effect of incorporating unpublished data into 41 meta-analyses of nine drugs approved by the FDA in 2001 and 2002 found that the conclusions drawn would have been the same in just three cases.

Interestingly, the remaining 38 cases were evenly split, with the efficacy of the drug reduced by the addition of the missing data in half of the cases, as might be expected, but increased in the other half.

Selective and under-reporting of clinical trial data is "a threat to the integrity of evidence-based medicine", according to the BMJ, which calls for the setting up of a global database - perhaps run by the World Health Organization - for all raw data from human trials.

Meanwhile, an article in the open-access journal PLoS Medicine calls for greater transparency in the reporting of patient recruitment targets for trials to registries such as clinicaltrials.gov, as so many studies are terminated early.

Final recruitment figures should be made available, as well as information on issues that could have affected recruitment, say the authors, as this data will be of interest to patient organisations, sponsors and clinical investigators.

5th January 2012

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