ABPI moves to improve compliance
pharmafile | February 28, 2013 | News story | Sales and Marketing | ABPI, NHS, alltrials, goldaccre, whiehead
The ABPI has fired its latest salvo in the clinical trial transparency debate by announcing it will appoint a new body to monitor pharma’s compliance with the trial-related parts of the Code of Practice.
An ‘independent, third party service provider’ will be appointed, with the ABPI reporting any non-compliance with trial registration and posting of summary results to the PMCPA, which enforces the Code.
Pharma companies are currently expected to register current and future trials within 21 days of enrolling the first patient.
Results must be published within one year of marketing authorisation or one year from completion for marketed products, the Code says.
The ABPI announcement comes a day after Roche said it was increasing third-party access to its own data.
“Hiring a third party provider to ensure that companies fulfil their obligations in the ABPI Code of Practice to register clinical trials and publish summary results, is a significant step and illustrates how seriously we take this issue,” said ABPI chief executive Stephen Whitehead.
From July this year, a new toolkit will be launched containing good practice guidelines, compliance checklists and template standard operating procedures for pharma companies. ABPI will also hold workshops on how to address the issue of disclosing historical data.
“We also want to ensure that we work collaboratively with all health stakeholders and international colleagues to agree a pragmatic approach which is in the interests of patients while protecting the commercial research model,” Whitehead added.
Pharma has “always accepted that making data more transparent is important”, he insisted. “All parties must now decide together how exactly this is achieved,” Whitehead added.
The ABPI has been under fire over the past year from campaigners such as Bad Pharma author Ben Goldacre.
The AllTrials campaign is calling for clinical trials to be registered and the disclosure of their results plus clinical study reports (CSRs) to help improve transparency and aid research.
Speaking at this week’s PharmaTimes head-to-head debate, Whitehead was scathing of the attacks on pharma. “We’ve been on trial for several months,” he said. “It’s a complete travesty of the truth. I’m tired of seeing my industry attacked.”
He was also at pains to emphasise ABPI has been working towards data transparency for some time: “We were on this journey before Bad Pharma was a twinkle in the delightful Ben Goldacre’s eyes,” Whitehead said pointedly.
The ABPI would not respond to what he called “PR-driven initiatives such as AllTrials”, he said.
In a pointed reference to Goldacre’s high profile on social media, Whitehead added: “I recognise the value of Twitter as a campaign tool but this issue cannot be summarised in 140 characters. We agree that summary trial evidence should be made available for both new and existing medicines. Mechanisms for doing so are still being finalised,” he concluded.
Yet momentum towards disclosure is growing: earlier this month GlaxoSmithKline announced its support for AllTrials – the first pharma company to do so.
The European Medicines Agency is already working on exactly how it will release clinical trial data. Reports from its working parties are expected in April.
However, European pharma trade body EFPIA is against what it calls ‘indiscriminate’ transparency.
And EFPIA board member and UCB chief executive Roch Doliveux yesterday warned of what he called data ‘voyeurism’.
Adam Hill
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