New study shows clinical trial transparency improving

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.

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:

307 or 90% had results disclosed on a registry or in scientific literature within 12 months of first regulatory approval or trial completion, and

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.

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.”