Pharma companies in the UK now have access to a set of guidelines on how to disclose trial data from clinical studies in order to fit transparency requirements.
The toolkit from trade body the Association of the British Pharmaceutical Industry (ABPI) comes in the wake of growing calls for improved access to trial data in order to better assess the effectiveness of drugs in an independent manner.
This campaign has been led by AllTrials – a group that has received backing from organisations such as NICE, IQWIG and even GlaxoSmithKline (GSK), but has been dismissed by the ABPI as “PR-driven initiative”, with the trade body claiming to have had plans to improve transparency long before AllTrials was launched.
It seems that the industry is on its way to greater access to data in some form, after commitments from the European Federation of Pharmaceutical Industries and Associations (EFPIA) and plans in place from the European Medicines Agency (EMA), although there is still great debate on this can be implemented.
The ABPI toolkit is designed to improve the transparency process based on current guidance and follows a commitment made in February 2013 to improve compliance through the use of an independent third party to monitor member companies and report infractions to UK pharma’s self-regulatory body the Prescription Medicines Code of Practice Authority (PMCPA).
The clinical trial disclosure toolkit expands on that by proving guidance in 11 areas, including good practice guidelines, disclosure checklists and template standard operating procedure.
Specific topics include the registrations of clinical trials with the European database EudraCT as well as a definition of constitutes the sort of patient level data that research organisations need access to for meta-analysis.
“These documents are intended as an additional support to guide companies of all sizes through the different steps of the disclosure process,” said the ABPI.