EMA’s publication of clinical data a success

First report on unprecedented transparency policy shows high user satisfaction

The European Medicines Agency (EMA) has published the first report on the implementation of its flagship policy on the publication of clinical data (Policy 0070). Under this policy citizens, including researchers and academics, can directly access thousands of pages from clinical reports submitted by pharmaceutical companies to EMA in the context of marketing authorisation applications for new medicines as of 1 January 2015. Clinical reports give information on the methods used and results of clinical trials conducted to demonstrate the safety and efficacy of medicines.

The report covers one year from the launch of EMA’s clinical data websiteExternal link icon on 20 October 2016 and lists the 50 medicines for which clinical data were published, including orphan, paediatric, biosimilar and generic medicines, as well as the corresponding 54 regulatory dossiers. These data have attracted a total of 3,641 users, resulting in 22,164 document ‘views’ and 80,537 ‘downloads’ for non-commercial research purposes.

The report sheds light on the total number of documents published, the amount of commercially confidential information (CCI) redacted and the anonymisation techniques used. EMA accepted 24% of CCI redactions proposed by pharmaceutical companies, with the result that only 0.01% of 1.3 million pages published contained CCI redactions.

Of the total respondents:

  • 62% were affiliated to the pharmaceutical industry
  • 14% to academia
  • 8% were patients
  • 8% healthcare professionals

The report summarises the reasons of the different user groups for accessing the data and their views on its usability:

“It shows that very few respondents disagree with EMA’s rationale for developing the policy”

“Most respondents strongly agree that publishing clinical data increases public trust in EMA’s decision-making and that it allows the reassessment of clinical data”

 The Agency also provided one-on-one assistance to individual companies to prepare them for the publication of clinical data. As a result, EMA published an average of six dossiers a month in the period from October 2017 to May 2018, reaching the 100th published dossier milestone on 29 May 2018.