ABPI promotes trial transparency checklist

08 September 2013

The Association of the British Pharmaceutical Industry (ABPI) has released an online clinical trial disclosure toolkit to help drugmakers comply with growing transparency requirements. 

In a timely addition to the ongoing debate over clinical trial transparency, ABPI has posted eleven documents on its website. Included are: 

Points to consider when managing disclosure; 

Process flow maps to map companies’ disclosure processes relating to trial registration and results disclosure; 

A template standard operating procedure on clinical trial registry; and 

Self-training and Q&A documents.

ABPI hopes the documents will help drug makers navigate the research landscape, which has become an obstacle course in recent months with regard to data transparency. 

However, the group, which represents more than 180 pharma companies, stresses the toolkit 'is not intended and should not be construed as regulatory or legal advice'.

ABPI notes that its code of practice already requires members to register current and future trials within 21 days of enrolling the first patient. The organization also requires members to publish trial results within a year of a drug’s marketing authorization or a year post-study completion for products already on the market.

Debate over trial transparency has seen an upsurge as various stakeholders continue to push and pull on the need for more trial data. Recently, the European Medicines Agency released a draft policy paper on its plans to proactively publish data submitted for product approvals in the EU.  

'Research is a truly global activity, with the UK supplying less than two percent of patients to global clinical trials,' said ABPI Chief Executive Stephen Whitehead. '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.'