Following a change to the ABPI Code of Practice in 2012, companies are obliged to publish all clinical trial results within one year of marketing authorisation and publically register new clinical trials within 21 days of the first patient being enrolled. This is in line with the International Federation of Pharmaceutical Manufacturers and Associations Code of Practice. The ABPI also commissioned research into clinical trial transparency to assess rates of clinical trial disclosure by industry.
Indeed, the pharmaceutical industry has been and continues to be committed to evolving and addressing the issues relating to transparency in clinical research. The first joint position relating to clinical trial transparency was launched in 2005 and was last updated in 2009.
It is important to recognise that research is a truly global activity, with the UK supplying less than 2% of patients to global clinical trials. 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 on-going discussions around clinical trial transparency.
In February 2013 the ABPI committed to providing a disclosure toolkit for companies to help them meet their requirement for trial transparency under the Code of Practice.
This toolkit provides good practice guidelines, disclosure checklists and a template standard operating procedure for pharmaceutical companies. These materials will be updated regularly in line with changes to international regulatory requirements.
The clinical trial disclosure toolkit has been updated in view of recent changes on EU Clinical Trial Regulations and the new European Medicines Agency (EMA) policy on the publication of clinical trial data.
The information provided in this toolkit for companies is provided in good faith, and every reasonable effort is made to ensure that it is accurate. The toolkit is not intended and should not be construed as regulatory or legal advice. The ABPI cannot in any circumstances accept responsibility for any errors or omissions and users should satisfy themselves as to their legal obligations.
The disclosure toolkit consists of the following 12 documents: