Transparency within Clinical Trials – The new EU Regulation and Stakeholders chance to provide opinions
The new European Clinical Trial Regulation (536/2014) introduces a degree of transparency into information relating to clinical trials performed within EU member states. The transparency features of this new regulation cover the authorisation, conduct and results of Clinical Trials of Investigational Medicinal Products and will involve:
1) A new EU database and a Portal for accessing this database. This will be used for the submission of clinical trial dossiers for approval by competent authorities and ethics committees across the whole of the EU. This database, yet to be developed by the EMA, will be publically accessible. However, in some cases, the public availability of the data will be limited. These instances are listed as:
• Protection of company confidentiality
• Protection of personal data
• Protection of confidential communications between sponsors and Member States in association with the preparation of the assessment report for the trial
• Ensuring effective supervision of the conduct of the clinical trial by Member States
2) Submission of a results summary and a lay-person summary within one year of the end of the trial in the EU via the portal into the database.
3) Submission of a Clinical Summary Report 30 days after the granting of a Marketing Authorisation of a new medicine to the portal.
The new regulation, although published in the Official Journal (OJ), is not yet effective. The EU Database and Portal are required for this regulation to be effective. These are currently in development within the EMA and are expected to be available sometime after 28-May-16. Awareness of the database and portal will be made via a notification in the OJ.
Prior to the release of the database and portal, the EMA are performing a public consultation relating to the transparency aspects of the new clinical trial regulation. Although there will undoubtedly be some concern within the pharmaceutical industry, relating to confidentiality issues and the concern of research efforts being readily available to competitors, it must be realised that there is considerable pressure on making research generally more publically accessible and clinical trials should not be any different. It is only with adequate feedback from stakeholders that the EMA can consider the opinions of stakeholders for the development of this database and portal. ‘Adequate’ means a fair and valid feedback on the implications of this transparency on stakeholders and their research rather than a general rant and moan over this issue.
This public consultation ends on 18-Feb-15 and stakeholders’ contributions should be made using a template form, which is available via a link in the cover page of the consultation document. This is located at:
The press release by the EMA relating to this public consultation is located at:
All stakeholders are advised to carefully review the transparency aspects of the regulation and provide to the EMA their thoughts and opinions relating to the practical application of the transparency rules for the clinical trial database and portal.