ABPI to introduce new clinical trial transparency measures
The Association of the British Pharmaceutical Industry (ABPI) 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 non-compliance with trial registration and posting of summary results.
These measures support the current requirement, 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 authorization or one year from completion for marketed products.
A new toolkit will 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 improve transparency for patients, the public and healthcare professionals in general, and to provide access to the relevant data necessary for advancing certain types of research.
“On the issue of historical data, we also want to ensure that we work collaboratively with all health stakeholders and international colleagues to agree to a pragmatic approach which is in the interests of patients while protecting the commercial research model,” said Stephen Whitehead, CEO of the ABPI. “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.”