The European clinical trials regulation (No 536/2014): changes and challenges.

Introduction: In recent years, a significant decrease in the number of clinical trials was observed among EU countries. This decline could be attributed to several factors, including the financial crisis of EU countries, the requirements introduced by the Directive 2001/20/EC and the increased market attractiveness of not EU countries.Areas covered: The EU Clinical Trials Regulation (CTR) 536/2014 was adopted in April 2014 by the European Parliament. The main changes arising from the CTR, including but not limited to the activation of a new EU portal, the potentiation of the already existing EU database and the requirement to provide plain language summaries of clinical trials, are aimed to improve the competitiveness of Europe in clinical research scenario and promote a faster approval of clinical trials. In this review, data related to the CTR 536/2014 and its potential implications in terms of transparency are based on pertinent papers that were retrieved by the PubMed database and the internet.Expert opinion: The full implementation of the CTR 536/2014 requires close cooperation between EU member states and regulatory agencies. Some aspects should be carefully considered such as the interaction with ethics committees, the insurance coverage and the protection of personal data issues.