All clinical trials carried out in European Union/European Economic Area (EU/EEA) are entered into the EudraCT database which is hosted by the European Medicines Agency (EMA). Since 21 July 2014 sponsors of clinical trials must post trial results on this data base on a systematic basis and the summary results are publicly available on the website at https://eudract.ema.europa.eu/.
Furthermore, since May 2004, summaries of the results of clinical trials conducted in the EU/EEA are publicly available through the EU Clinical Trials Register, at https://www.clinicaltrialsregister.eu/.
From 1 January 2015 the EMA pro-actively publishes the clinical reports submitted as part of applications made to the Agency for marketing authorisation for human medicines. Since 2010 the Agency had been releasing clinical trial reports on request, under its access-to-documents policy.
On 16 April 2014 a new EU Regulation on clinical trials was adopted and will come into force in 2017. This Regulation aims to increase transparency and availability of information on clinical trials and their results. A new clinical trials portal and database will be used for submission and maintenance of clinical trial applications and authorisations within the EU and it will serve as the source of public information on all clinical trials conducted in the EU.
Under this new Regulation the public will be able to access extensive details of each trial including the major characteristics of the trial, the start and end of recruitment, end date of the trial and substantial modifications to the trial. These details will be made public as they occur starting with the decision on the trial.
A summary of results and lay summary will be published 12 months after the end of the trial. For trials which are part of a marketing authorisation application in the EU, clinical study reports will also be published 30 days after the procedure for granting the marketing authorisation has been completed or the application has been withdrawn.
The Regulation requires that the database will be publicly available unless an exception applies, for example protection of personal data or protection of commercially confidential information, unless there is an overriding public interest.
Rules for the operation of these exemptions are currently being developed by the EMA with input from member state competent authorities, including Ireland's Health Products Regulatory authority (HPRA).
With particular regard to the Deputy's query on the human papilloma virus (HPV) cervical cancer vaccine, there are 2 authorised HPV vaccines available in Ireland (Gardasil® and Cervarix®). Gardasil® is the vaccine used by the HSE in the School Immunisation Programme.
The Deputy may be interested to know that the Summary of Product Characteristics (SmPC) for Gardasil®, the document containing all the product information contains detailed information on the clinical studies used to support its use (section 5.1). The SmPC is available at http://www.medicines.ie/medicine/11524/SPC/GARDASIL/
The Deputy may be also interested to know that as part of its ongoing monitoring and review of medicines, the EMA is currently undertaking a review of the HPV vaccines "to further clarify aspects of their safety profile" although the agency points out that this review "does not question that the benefits of HPV vaccines outweigh their risks" . The review is specifically focussing on rare reports of two conditions, complex regional pain syndrome and postural orthostatic tachycardia syndrome associated with heart rate increase.
