Transparent – /trænsˈpærənt; -ˈpɛər-/ – adjective – easy to see through, understand, or recognize; obvious.
Developing medicines in not easy to understand. It is a complex process that takes times, involves many hundreds of people and multi millions of pounds.
Not least of all in this complex process are the clinical trials which are undertaken to test the safety and efficacy of potentially life-enhancing and life-saving medicines before bringing them to patients.
With this in mind it is no surprise that we are regularly caught in debate as to how transparent the pharmaceutical industry is about the clinical trials it undertakes. Clinical trials are not easy to see through – they are multifaceted and complicated and, to the untrained eye, difficult to understand.
This doesn’t mean however that we shouldn’t attempt to make them, and their results, accessible for the benefit of patients, healthcare professionals and industry and the ABPI firmly believes in clinical trial transparency which respects the privacy of participants and the commercial sensitivities of companies.
And the good news is, as we celebrate International Clinical Trials Day and the first ever clinical trials undertaken in 1747, we are achieving this aim. Clinical trial transparency update: an assessment of the disclosure of results of company-sponsored trials associated with new medicines approved in Europe in 2012 is the ABPI’s follow-up study tracking disclosure rates of clinical trials for company-sponsored trials.
Together with the first study 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.
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.
We are undoubtedly becoming more transparent. Another definition of transparent is ‘candid, open, or frank’. And in this sense industry is being thoroughly transparent.
We have come a long way but we acknowledge that there is still some way to go before we reach 100% transparency in company-sponsored trials. We’ve not shied away from this and we are committed to continuing our annual research in order to monitor our performance with a view to seeing full transparency on company-sponsored trials for newly approved medicines in coming years.
As we reach International Clinical Trials Day 2015 we can enjoy a short celebration of our industry-wide success towards clinical trial transparency for medicines approved in 2012. But more importantly, we mark the event with the start of research assessing disclosure rates for medicines approved during 2013 – another checkpoint on our journey to 100% transparency.
It is our hope that we will mark next year’s International Clinical Trials Day with even higher rates of disclosure – a demonstration that we are progressing on our chosen route and succeeding in implementing the changes of process and practice that will see us through to 100% transparency on company-sponsored trials.
Dr Virginia Acha
Executive Director – Research, Medical and Innovation