The European Medicines Agency (EMA) announced it is moving forward with its plan to release the clinical data used in marketing authorization applications, following consultation and deliberations. A few months prior to that, around April 2014, the European Parliament passed a new regulation governing clinical trials, Regulation (EU) No 536/2015, overwhelmingly repealing Directive 2001/20/EC. In a move toward full transparency, European regulators will soon publish clinical trial reports on all drugs approved for marketing in the European Union (EU). The policy, which was approved in principle on June 12 by the European Medicines Agency’s (EMA) management board, is expected to be formally adopted at the board’s October 2 meeting.
The move will allow researchers to download clinical trial reports from the organization’s website, enabling them to analyze, share, and compare trial data once the decision-making process for the medicine in question has been completed.
The most significant change of Clinical Trials Regulation is increased transparency measures, which allow clinical trials to be registered in a “publicly accessible and free of charge database which is a primary or partner registry of, or a data provider to, the international clinical trials registry platform of the World Health Organization (WHO ICTRP).”
Moreover, the regulation also calls for the creation of a new, publicly accessible, clinical trials database and portal. The information submitted to the database will be made publicly available, except where certain exceptions apply, such as:
(1) Protection of personal data;
(2) Protection of commercially confidential information;
(3) Protection of confidential communication between Member States in the preparation of their assessment; and
(4) Protection of the supervision of clinical trials by Member States
In the immediate aftermath of passage of the Clinical Trials Regulation, EMA adopted a policy on the proactive publication of clinical data. Companies are required to publish a summary of the results of all clinical trials within a year of a trial’s completion. For trials used to support a product’s marketing authorization, companies are required to publish the “clinical study report within 30 days after the day the marketing authorization has been granted, the procedure for granting the marketing authorization has been completed, or the applicant for marketing authorization has withdrawn the application.”
Furthermore, the policy mandates EMA to publish the clinical reports used in all marketing authorization applications submitted. As such, EMA expects the first clinical reports released under the policy to be published in mid-2016.
The EMA announced it is committed to continuously extending its approach to transparency. A key goal in this process is the publication of clinical-trial data for medicines once the decision-making process on an application for a European Union (EU) – wide marketing authorization is complete. EMA embarked on this process because it believes that the release of data is about establishing trust and confidence in the system, because it will allow the public to better understand the Agency’s decision-making. In addition, academics and researchers will be able to re-assess data sets. The publication of clinical reports will also help to avoid duplication of clinical trials, foster innovation and encourage development of new medicines.
The policy shall be entered into force on January 1 2015. It will apply to clinical reports contained in all marketing-authorization applications submitted on or after this date. The reports will be released as soon as a decision on the application has been taken. The publication of the first reports is foreseen for mid-2016.