Throughout the industry, companies are publishing increasing amounts of clinical data. Following a change to the ABPI Code of Practice in 2012, companies are obliged to publish all clinical trial results within one year of marketing authorisation and publically register new clinical trials within 21 days of the first patient being enrolled.
In common with alltrials.net, the ABPI believes greater transparency of clinical trial results, and appropriate access to trial data, past and present, is in the best interests of patients and medicine. However, this can only be true where proper attention is given to some crucial considerations.
Firstly, there is a need to protect patient confidentiality and personal data. At present, disclosure policies protect patients’ personal data and consent is not given for their data to be utilised by other third parties, for different purposes and at different times.
In addition, the release of commercially confidential information could undermine investment in the research and development of future medicines. This is ultimately not in the interests of patients, who would not be well served by dis-incentivising research based biopharmaceutical companies and commercial organisations from other life sciences sectors from making the substantial investments and shouldering the risks that are necessary to develop new innovative medicines.
Furthermore, the disclosure of all clinical trial results, past and present, would involve making vast amounts of data, held in an enormous variety of formats across the world, accessible for medicines long established as safe and effective by the clinical community. Release on reasonable request, via a transparent and accountable process, may be a more pragmatic way forward and this debate is on-going. We believe there must be measures in place to ensure that the raw data from clinical trials can only be shared with trustworthy and competent scientific institutions that are capable of conducting appropriate analyses.
Throughout these discussions, it is important to recognise that 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 these on-going discussions.
Finally, the debate around clinical trial transparency is important but it is essential that patients have confidence that the medicines their doctors prescribe for them are appropriately safe and effective. However much data is published - or not - the regulatory authorities have access to all the relevant data as part of the approval process for new medicines.
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Notes to editors
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.