British Pharma Group Promotes Trial Transparency Checklist

A UK industry group 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, the Association of the British Pharmaceutical Industry (ABPI) has posted 11 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 drugmakers 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.

And last month, PhRMA and the European Federation of Pharmaceutical Industries and Associations released a joint set of principles for sharing clinical trial data.

In the midst of all this, ABPI has been a key player in discussions with regulators, industry stakeholders and patient advocacy groups on balancing the need for more trial transparency against the need to protect trial participants and intellectual property.

“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.”

If you want your drug or device to earn trust on the market, sharing trial data will prove that you have left no stone unturned in the safety-testing process. Preparing for Expanded Clinical Trial Data Transparency US and EU Initiatives on the Horizon will inform and instruct you on how to comply with upcoming U.S. and EU trial transparency moves, so sign up to participate in this webinar today.