Study: Clinical trial transparency improving
Transparency amongst industry-sponsored clinical trials continues to improve with results of 90% of trials on all new medicines approved by the EMA in 2012 disclosed within a 12-month timeframe, according to an Association of the British Pharmaceutical Industry (ABPI) study.
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.
Dr. Virginia Acha, ABPI’s executive director research, medical and innovation, said, “This study highlights an encouraging trend toward 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 toward 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:
- 307 or 90% had results disclosed on a registry or in scientific literature within 12 months of first regulatory approval or trial completion
- 312 or 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.
“While we are not seeing disclosure rates at 100% yet, we are seeing a sustained trend toward improved disclosure of industry-sponsored trials associated with new medicines,” said Bryan Deane, co-author of the study.
“Generally speaking, it is the older, smaller, earlier phase trials whose results remain undisclosed,” said Deane. “This is not surprising given that for this group of new medicines, many of the early phase trials were conducted around 10 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.”