New study shows improvement in clinical trial transparency
Study highlights tangible evidence of increased openness in stakeholder relationships
An ABPI study published in Current Medical Research and Opinion (CMRO) shows that transparency in industry sponsored clinical trials continues to improve: the results of 90% of the trials approved by the European Medicines Authority (EMA) in 2012 were disclosed within a 12-month timeframe.
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 more consistent disclosure in a timely manner.
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 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,’ she added.
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, 307 (90%) had results disclosed on a registry or in scientific literature within 12 months of first regulatory approval or trial completion and 312 (92%) had results disclosed by the end of the study at 31 July 2014.
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: ‘Although we are not seeing disclosure rates of 100%, we are seeing a sustained trend towards improved disclosure of industry sponsored trials. Generally speaking, it is the older, smaller, earlier phase trial results that remain undisclosed. This is not surprising given that for this group of new medicines, many of the early phase trials were conducted about 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 will continue to improve.’
