These measures support the current requirement in the ABPI Code of Practice which stipulates that current and future trials must be registered within 21 days of enrolling the first patient, and results must be published within one year of marketing authorisation or one year from completion for marketed products.1
From quarter three this year, a new toolkit is also to be introduced that will provide good practice guidelines, compliance checklists and template standard operating procedures for pharmaceutical companies.
In addition, the ABPI will host a series of workshops with all relevant stakeholders to explore how best to address the issue of historical data, and disclosure requirements, to meet two distinct needs – firstly, improve transparency for patients, public and health care professionals in general and secondly, access to the relevant data that are necessary for the advance of certain types of research.
Commenting, Stephen Whitehead, Chief Executive of the ABPI, said:
“The ABPI is a strong advocate for transparency in clinical trial data and so I am pleased to announce the introduction of new measures which will encourage greater compliance. Hiring a third party provider to ensure that companies fulfil their obligations in the ABPI Code of Practice to register clinical trials and publish summary results, is a significant step and illustrates how seriously we take this issue.
“On the issue of historical data we also want to ensure that we work collaboratively with all health stakeholders and international colleagues to agree a pragmatic approach which is in the interests of patients while protecting the commercial research model. The pharmaceutical industry has always accepted that making data more transparent is important, but all parties must now decide together how exactly this is achieved.”
ABPI Press Office
Tel: +44 (0) 20 7747 1410
Mobile: +44 (0) 7850 312064
Notes to editors
Specifically, these measures support the current ABPI Code of Practice which requires in Clause 21.3 disclosure of clinical trials in accordance with the Joint Position on the Disclosure of Clinical Trial Information via Clinical Trial Registries and Databases and the Joint Position on the Publication of Clinical Trial Results in the Scientific Literature. The joint positions include requirements that current and future trials must be registered within 21 days of enrolling the first patient, and results must be published within one year of marketing authorisation or one year from completion for marketed products.
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.