Dr Virginia Acha, ABPI Executive Director of Research, Medical and Innovation, comments on the vital importance of clinical trial transparency.
Dr Virginia Acha said: “We are dedicated to ensuring greater transparency in clinical trials as it is of vital importance for the benefit of both patients and healthcare professionals for the safe and efficient development of medicines. We will continue to work closely with all parties to ensure that the UK is a robust and internationally leading place to undertake clinical research safely and openly.
“For example, in June we published our study in the peer-review journal Current Medical Research and Opinion (CMRO) showing that transparency amongst industry-sponsored clinical trials continues to improve with results of 90% of trials on all new medicines approved by the European Medicines Authority (EMA) in 2012 disclosed within a 12-month timeframe. Together the results highlight that since 2009 the disclosure rate of industry-sponsored clinical trials at 12 months has steadily improved year-on-year from 71% in 2009, to 81% in 2010, 86% in 2011 and 90% in 2012 – indicating that the pharmaceutical industry is achieving disclosure in a timely manner more consistently than ever before.
“We do acknowledge, however, that there is more work to do and, alongside our European and international counterparts, we will continue to work with companies towards greater transparency across the industry globally. The next phase of the disclosure research is in progress for products approved by the EMA in 2013, with the consultation process which started from 1 August 2015. A parallel compliance audit exercise will be conducted in order to help prepare companies for the new EU CTR transparency requirements coming into force from 2016/17.”
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.
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