First EMA publication on the results of transparency policy on the publication of clinical data
The European Medicines Agency (EMA) has recently published the results of their transparency policy on the publication of clinical data which they started implementing almost 3 years ago. According to this policy (Policy 0070), reports on clinical trials where efficacy and safety of new drugs were studied are now open to public including scientists and academics. The Agency have been given the direct access to all reports which were submitted to them as a part of marketing authorisation applications since 1 January 2015.
The published report consists of the data and statistics which cover only one year from 20 October 2016 – a milestone when the EMA’s website on medicines and corresponding clinical data was launched. Therefore, this report contains 54 regulatory dossiers and information on 50 medicines for which dossiers were submitted to the EMA. Amongst these medicines there are orphan, paediatric, biosimilar and generic drugs. The statistics is impressive: there were 80537 of downloads and 22164 document ‘views’ (all for noncommercial objectives).
The report also reveals some information on the overall quantity of published documents and the number of documents which were redacted for the purpose of anonymisation and hiding commercially confidential information (CCI). Interestingly that the EMA has accepted only 24% of CCI redactions proposed by the pharmaceutical companies which led to the fact that only 0,01% of 1,3 million published pages had CCI corrections. The report also tells about the anonymisation techniques which were used to protect CCI and the influence of these techniques on final data quality.
The other part of the statistics is also fairly interesting. The vast majority of users work in the pharmaceutical business, 14% were academics and only 8% of healthcare professional and 8% of ordinary patients accessed this website. The report also analyzes people attitude to the new EMA policy. It turned out that most of the responders totally support it and think that such policy may increase public trust to the EMA activity.
