ABPI publishes trial disclosure ‘toolkit’
pharmafile | August 15, 2013 | News story | Medical Communications, Sales and Marketing | ABPI, EFPIA, Goldacre, transparency
The ABPI has today launched a new clinical trial disclosure toolkit to help pharma companies meet data transparency requirements.
The toolkit is comprised of 11 elements including good practice guidelines, disclosure checklists and template standard operating procedure.
The UK pharma lobby group said that these documents are intended as an ‘additional support’ to “guide companies of all sizes through the different steps of the disclosure process”.
The ABPI added that it will also be holding workshops on how to address the issue of disclosing historical data – although it falls short of full disclosure of raw data sets.
It announced its creation of a toolkit in February this year, one day after the PharmaTimes head-to-head debate between the group’s chief executive Stephen Whitehead and Bad Pharma author Dr Ben Goldacre.
Pharma has been under intense pressure this year to publish more of its trial results from the campaign group AllTrials, which was created by Goldacre, the British Medical Journal and Sense about Science, among others.
The initiative, which now has over 56,500 signatures that include GlaxoSmithKline and NICE, released its manifesto last week saying it wants planned clinical trials being registered with a summary of the trial protocol before the first participant is recruited.
It has also said it wants to see a summary of results to be made publicly available where the trial was registered, within one year of completion of the trial. But AllTrials are clear that it does not want individual patient data to be published – something of a concern to pharma.
Whitehead has called AllTrials a ‘PR initiative’ and attacked the campaign for transparency, saying: “We’ve been on trial for several months. It’s a complete travesty of the truth. I’m tired of seeing my industry attacked.”
But it seems that the ABPI has now bowed to public pressure on taking an active role in releasing more data, although it still falls short of what AllTrials would like.
Speaking about the toolkit, Whitehead said: “The ABPI is a strong advocate for transparency in clinical trial information. Earlier this year we committed to providing a clinical trial disclosure toolkit to companies and I am delighted that this is now available on our website for any company to use. The pharmaceutical industry has been, and continues to be, committed to addressing the issues relating to transparency in clinical research.
“Research is a truly global activity, with the UK supplying less than 2% of patients to global clinical trials. As part of a global industry, we are actively engaging with our European and international counterparts, as well as many other stakeholders, to input into ongoing discussions around clinical trial transparency”.
New rules
This forms part of a voluntary agreement by ABPI members and is not a legal or regulatory policy.
The European Commission and the European Medicines Agency are currently working on new rules for next year that will mandate greater trial transparency for pharma firms marketing their medicines in the EU.
The European pharma lobby group EFPIA said last month it would rather see a more moderate data release plan in place, rather than full disclosure.
The toolkit will be available to download from the ABPI website and can be accessed here.
Ben Adams
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