The Association of the British Pharmaceutical Industry has unveiled new measures to help boost compliance with data transparency clauses in its Code of Practice, as promised by chief executive Stephen Whitehead at last night's PharmaTimes head-to-head debate with Bad Pharma author Ben Goldacre.
As per the Code, all companies are required to register a trial within 21 days of the first patient being admitted, and post the results within one year of marketing authorisation.
But in his address at the debate, Whitehead conceded that compliance with the ABPI's data transparency provisions "was never properly monitored," which has prompted the introduction of a new process to ensure that pharma fulfils these obligations.
Under the process, an independent, third party service provider will be appointed to ensure compliance with data transparency provisions within the Code, and the ABPI will report any breaches to its policing arm, the Prescription Medicines Code of Practice Authority.
In addition, a new toolkit will be available from the third quarter of this year to encourage greater compliance, providing good practice guidelines, compliance checklists and template standard operating procedures for pharmaceutical firms, the Association said.
The ABPI will also will host workshops with relevant stakeholders to explore how to address the issue of disclosing historical data, to improve transparency and boost access to data crucial to advancing certain types of research.
A collaborative approach
Whitehead said that the ABPI is keen to ensure a collaborative approach 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".
The industry has long accepted the importance of making data more transparent, "but all parties must now decide together how exactly this is achieved,” he stressed.
The European Union is currently revising the Clinical Trials Directive (2001/20/EC), and proposed regulation by the European Commission will require sponsors to submit a “summary of results” to the EU’s clinical-trial database within one year of a clinical trial ending.
The benefits of greater transparency are clear, but the UK’s BioIndustry Association recently warned that too stringent requirements for the publication of clinical-trial data could put investment in early-stage research at risk.