We welcome the agreement between PhRMA and EFPIA on responsible clinical trial data sharing. In particular, the commitment to develop a consistent and objective mechanism to share patient-level and study-level clinical trial data with qualified scientific and medical researchers, is an important one.
The ABPI is already actively engaged in this debate and in recent months we have run and participated in workshops with healthcare stakeholders to move forward the debate on clinical trial transparency. Earlier in the year we also launched new measures to monitor disclosure in relation 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 we will take on the responsibility for reporting to the PMCPA non-compliance with trial registration and posting of summary results.
All these measures support the current requirements 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.
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*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.