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trials

Improving trial publications: where do we start?

Carl Heneghan
Last edited 3rd May 2010

There has been considerable interest in the transparent publication of trial results in both the media and the big journals. Whilst calls for drug companies to be more open with research findings are on the increase.

Delamothe argues:
‘that patients should demand as a condition of their participation in trials that their anonymised data should be made available to anyone who asks for them and that ethics committees should back them up, insisting that protocols allow for data sharing.'

Half of trials supporting FDA applications go unpublished 5 years after approval. A further example of the controversy in action, is the recent Cochrane review on Tamiflu in adults, which Fiona Godlee, editor of the BMJ questions ‘Why don’t we have all the evidence on oseltamivir?’

But, the problem is once we have all this data who is going to look at it? Even one trial alone is going to take a year’s work. Who is independent enough to do this work and who will fund it? There are only a few epidemiologists in the world barmy enough to do this sort of work. I should know I’m one of them.

A recent systematic review published in BMC trials of pharmacological interventions for acute ischaemic stroke that were completed, revealed of 940 trials 125 (20%) were completed but not published in full. Gibson who led the work states: ‘Responsibility for non-publication lies with investigators, but pharmaceutical companies, research ethics committees, journals and governments can all encourage the timely publication of trial data. ‘

Therefore the question right now is not ‘let us have the raw data’ but, ‘let’s get the stuff published in the first place.' My standpoint would be to have a two year maximum to publication from the end of the trial outcome assessment. Otherwise trial registration should be removed from which ever organisation registered the trial in the first place.

Only simple solutions will make a differnce and its where we should start.

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