Overview of comments on EMA/641479/2014 Draft proposal for an addendum, on transparency, to the “Functional specifications for the EU portal and EU database to be audited – EMA/42176/2014”

  • Draft proposal for an addendum, on transparency, to the “Functional specifications for the EU portal and EU database to be audited – EMA/42176/2014” Europe-map-colour(20 Jan 2015)

The new European Clinical Trial Regulation (EU) No 536/2014 aims to foster innovation through simplification of the clinical trial application process, and to increase transparency and availability of information on clinical trials and their results.  The key instrument to ensure transparency of clinical trials is the new clinical trial portal and database that will be used for submission and maintenance of clinical trial applications and authorisations within  the European Union. The database will serve as the source of public information on clinical trial applications assessed, and clinical trials conducted in the EU, from the time of decision to authorise a trial up to the finalisation of those trials and inclusion of their results in the database. The Regulation gives EMA responsibility for its development and maintenance. The Regulation states that the EU database “shall be publicly available unless one or more exceptions  apply”. These are:

  • to protect personal data;
  • to protect commercially confidential information, in particular taking into account the marketing authorisation status of the medicinal product, unless there is an overriding public interest;
  • to protect confidential communication between Member States in preparing their assessment;to protect the supervision of clinical trials by Member States.
This consultation document set out proposals and options on the application of these exceptions in44  relation to the transparency provisions of the European Clinical Trial Regulation. Once finalised, this addendum will complement the functional specifications for the EU portal and database to be audited, which were drawn up by the Agency and endorsed by its Management Board in December 2014.  The aim of this consultation is to seek stakeholders’ views on the application of these exceptions, so  that they strike the right balance between respecting patients’ and doctors’ needs and the publics’  entitlement to extensive and timely information about clinical trials and developers’ and researchers’ need to protect their investments. A balanced approach is needed to protect public health and also51  foster the innovation capacity of European medical research, thus supporting the EU as a location for  innovative, cutting edge research that results in development of novel products and research into new and better uses of existing products.The information that will be made public for all clinical trials registered in the system will include:
  • the main characteristics of the trial comprising design, scientific and, where applicable, therapeutic intent, title, identification of the investigational medicinal products (IMPs), treatment arms, treatment population and number of subjects, inclusion and exclusion criteria and main objectives and endpoints;
  • conclusion of the assessment and decision on the trial;
  • information updated during the trial to indicate the start and end dates of recruitment;
  • substantial modifications to the trial;
  • the end date of the trial and 12 months later the summary of results and a summary in lay language;
  • clinical study reports for medicines for which a marketing authorisation has been granted, the procedure completed or the marketing authorisation application withdrawn.

Comments Received on the Consultation Document (Publushed 6 Nov 2015)

Note – The comments documents merely list comments received for each section without presenting the context.  Recommend you have the original consultation document open for reference