11 Mar 2013 Posted in ABPI statement By Press Office
“Clinical trials are the cornerstone of the research and development process and it is through trials that pharmaceutical companies are able to demonstrate the safety and efficacy of new medicines. Without clinical trials the pharmaceutical industry simply could not create new life saving and life changing medicines.
“The ABPI is a strong advocate for transparency in clinical trial data and is putting in place measures to ensure that it is happening. But disclosure of data must not compromise patient confidentiality and must be done responsibly, and for old trials, in a pragmatic manner. Any new measures that may be introduced should not lead to a reduction in the research and development of medicines in the UK. As part of the ABPI Code of practice, companies must 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 addition all pharmaceutical companies must submit all relevant data to regulators as part of the approval process for new medicines.
“In our submission to the Committee we include preliminary results from our own research which showed that for new medicines approved in 2010 in Europe, 79% of the evaluable trials conducted in patients had been published within a year of completion or product launch. To ensure that we reach our goal of 100%, the ABPI has recently announced that further measures will be introduced, including the development of a transparency toolkit and a compliance monitoring service."
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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.