The ABPI has today announced that it will put in place measures to monitor compliance to the clinical trial transparency provisions contained in the ABPI Code of Practice. An independent, third party service provider will be appointed to undertake this work, and the ABPI will take on the responsibility for reporting to the PMCPA non-compliance with trial registration and posting of summary results.
27 Feb 2013 Posted in News Release By Press Office
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.”
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