An ABPI study published today in the peer-review journal Current Medical Research and Opinion (CMRO) shows 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.
View Clinical trial transparency update: an assessment of the disclosure of results of company-sponsored trials associated with new medicines approved in Europe in 2012.
The study, conducted by Livewire Editorial Communications on behalf of the ABPI, is a follow-up to a
2013 study of disclosure rates. 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.
Commenting on the study’s findings, Dr Virginia Acha, the ABPI’s Executive Director Research, Medical and Innovation said: “This study highlights an encouraging trend towards greater clinical trial transparency by industry and tangible evidence of the increased openness in relationships with all stakeholders, including patients and healthcare professionals.
“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.”
Key findings of the study show that of the 340 industry-sponsored trials (completed before the end of January 2014) associated with all 23 new medicines approved by the EMA in 2012:
The study also showed that disclosure rates for larger, phase III trials were higher with 96% disclosure at 12 months and 97% at the end of the study.
Bryan Deane, co-author of the study, said: “Whilst we are not seeing disclosure rates at 100% yet we are seeing a sustained trend towards improved disclosure of industry-sponsored trials associated with new medicines.
“Generally speaking it is the older, smaller, earlier phase trials whose results remain undisclosed. This is not surprising given that for this group of new medicines, many of the early phase trials were conducted around ten years ago, before results could be posted on registries and at a time when few small phase I and II trials would have been published alone. Now that the registration and reporting of clinical trials has become routine it is fair to expect that transparency associated with industry-sponsored trials will continue to improve.”
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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