AllTrials campaign releases manifesto
The UK clinical trial transparency initiative AllTrials has released its first detailed manifesto as it looks to ramp up pressure on researchers to release all study data.
The manifesto, written by the AllTrials initiatuve that includes Sense about Science, the British Medical Journal and Dr Ben Goldacre, has published a four-point plan of what it wants to see from pharma and academic researchers.
This includes having planned clinical trials being registered with a summary of the trial protocol before the first participant is recruited. It also wants past trials that were not registered to be registered retrospectively.
The second point is that a summary of results should be publicly available where the trial was registered, within one year of completion of the trial. “Summary results from all past trials of medicines currently in use should be made publicly available on a register now,” the manifesto says.
The third wants trial sponsors or others who produce a full report for marketing authorisation or any other purpose to make this publicly available, while the fourth point reiterates that AllTrials is not calling for individual patient data to be made publicly available.
The transparency debate has become one of the biggest topics for pharma in 2013, but the industry is still fighting the requirement for all data to be released.
During the PharmaTimes debate in February, chief executive of the ABPI Stephen Whitehead said AllTrials was nothing but a ‘PR initiative’, adding that the lobby group would not be signing the register.
The two main pharma pressure groups – EFPIA in Europe and PhRMA in the US have both said they welcome elements of transparency, but are against full disclosure, arguing that it could impact patient confidentiality.
Jean-Michel Crossery, the UK head of Lilly, said recently that patients would rather have their money spent on developing new medicines, than having it used collecting data for old medicines, showing pharma’s attitude toward the initiative.
But the juggernaut of transparency is not slowing down, with swathes of the public signing the AllTrials register and pharma being attacked by observers over its defensive stance.
Dr Goldacre, author of Bad Pharma, told Pharmafile: “While some are still looking for excuses to avoid transparency, this document sets out what “all trials registered, all results reported” looks like in detailed, practical terms. I hope everyone interested in moving forward will engage and improve this document.”
The AllTrials register now has over 56,500 signatures and has gained big names and big backing – including over 80 patient groups as well as NICE, IQWiG, the BMA and, most importantly GlaxoSmithKline, currently the only pharma firm or group to sign.
The campaign wants one million signatures on the register, adding that with every 10,000 new signatures, the campaign will send the petition to health ministers in every country, and to regulators.
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