The toolkit is comprised of 11 elements, including good practice guidelines, disclosure checklists and template standard operating procedure. These documents are intended as an additional support to guide companies of all sizes through the different steps of the disclosure process.
Commenting on the launch of the toolkit, ABPI Chief Executive Stephen Whitehead said:
"The ABPI is a strong advocate for transparency in clinical trial information. Earlier this year we committed to providing a clinical trial disclosure toolkit to companies and I am delighted that this is now available on our website for any company to use. The pharmaceutical industry has been, and continues to be, committed to addressing the issues relating to transparency in clinical research.
"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 ongoing discussions around clinical trial transparency."
The toolkit is available to download from the ABPI website.
Notes to Editor
The ABPI represents innovative research-based biopharmaceutical companies, large, medium and small, leading an exciting new era of biosciences in the UK.
Our industry, a major contributor to the economy of the UK, brings life-saving and life-enhancing medicines to patients. Our members supply 90 per cent of all medicines used by the NHS, and are researching and developing over two-thirds of the current medicines pipeline, ensuring that the UK remains at the forefront of helping patients prevent and overcome diseases.
The ABPI is recognised by government as the industry body negotiating on behalf of the branded pharmaceutical industry, for statutory consultation requirements including the pricing scheme for medicines in the UK.
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.