ABPI Sets Guidelines on Clinical Trial Disclosure - Pharmaceutical Technology

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ABPI Sets Guidelines on Clinical Trial Disclosure
ABPI toolkit provides guidance to pharmaceutical companies on how to meet clinical trial transparency requirements



The Association of the British Pharmaceutical Industry (ABPI), a trade association for pharmaceutical companies in the UK, has launched launched a clinical trial disclosure toolkit toolkit in response to calls for transparency in clinical trial data. Pharmaceutical companies in the UK have access to the toolkit, which consists of 11 elements on how to meet clinical trial transparency requirements, including good practice guidelines, disclosure checklists and a template standard operating procedure. These documents provide guidance to pharmaceutical companies on the different steps of the disclosure process and will be updated regularly according to changes in international regulatory requirements.

“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,” said Stephen Whitehead, chief executive of ABPI, in a press statement. “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.”

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