EU Clinical Trials Register: Ushering Transparency for Patients
Increasing accessible information to patients and professionals.
In a clinical research environment of increasing number of ongoing Clinical Trials, it could be overwhelming to keep track on what is going on and what are the actual available studies for recruitment in each specific therapeutic area or a particular disease area, or which are the hospitals and countries where these trials are recruiting patients.
With the purpose of facilitating a friendly access to the patients as well as providing to the general population an adequate level of information on ongoing recruiting clinical trials, there are well established databases that keep updated information on these ongoing recruiting trials, together with the hospitals and sites enrolling patients in those clinical trials.
EudraCT: database for clinical trials
EudraCT database has been till recently the database used by National Competent Authorities in the EU (European Union) to upload the clinical trials´ data and to support tracking them appropriately.
It was established as a confidential database, in accordance with article 11 of Directive 2001/20/EC. However, and in order to meet the increasing need of patients and to facilitate transparency, the EU Clinical Trials Register was enabled in the EU.
Objectives of the EU Clinical Trials Regulation
The EU Clinical Trials Regulation´s principal objectives include fostering innovation and research in Europe, and increasing transparency of clinical trial information, as well as improving information-sharing while maintaining the high standards of patient safety.
History of the EU Clinical Trials Register
The EU Clinical Trials Register website was launched in March 2011 to provide the public with information held in the EudraCT database (https://www.clinicaltrialsregister.eu/), and, hence, provide the patients and public in general with an updated repository on the ongoing and recruiting clinical trials.
The EU Clinical Trials Register has been a primary repository in the World Health Organization (WHO’s) Registry Network since September 2011 and is a WHO Registry Network data provider and is also available on the WHO International Clinical Trials Registry Platform (https://trialsearch.who.int).
This EU Clinical Trials Register includes the description of phase 2 to phase 4 adult and pediatric clinical trials, for the latter with a reduced set of data fields, in which the investigational sites are located in the European Union and the European Economic Area (EU/EEA), which started after 1st May 2004; as well as a summary of the results of those clinical trials.
On the other hand, and since January 31st 2022, the Clinical Trials Regulation (EU) No 536/2014 repealed the Clinical Trials Directive 2001/20/EC.
In order to maintain and foster a strong transparency policy across the ongoing and finished clinical trial in EU, the requirement for the publication on a single website called CTIS (Clinical Trial Information System) of the data obtained from clinical trials, regardless of results, was established.
On this regard, and after the full implementation of the Clinical Trials Regulation (EU) No 536/2014 as of 31st January 2023, all initial clinical trial applications in the EU/EEA must be submitted through the CTIS.
And no new studies are uploaded in EudraCT. Moreover, Sponsors must transition the previous ongoing trials hosted on EudraCT to CTIS if at least one of the following conditions is fulfilled:
● If the EudraCT-hosted trial is to be conducted de novo in additional EU/EEA member state(s), to which a EudraCT CTA was not submitted before 31st January 2023 (this is considered a new trial application for this member state); or,
● If the EudraCT-hosted trial´s completion date is expected to be after 30th January 2025.
So that, the EU Clinical Trials Register should be publicly accessible, and data should be presented in an easily searchable format.
An EU database identifying each clinical trial information on the clinical trials included in CTIS would be available on https://euclinicaltrials.eu/, acting as a single point for information on Clinical Trials, and hence facilitating to the general public, patients and professionals to find all the corresponding details on any individual clinical trial as soon as it becomes available, such as the EU clinical trial number, name and address of the trial sponsor, start and end dates of participant´s recruitment, sites and hospital´s name and other relevant information on the trial itself.
After the full implementation of the EU CT regulation, a new clinical trial database (https://euclinicaltrials.eu/) is available and would be updated on an ongoing basis to progressively increase the relevant information on the initiated Clinical Trials in EU, which would eventually allow to increase and improve transparency and facilitate patients and professional to easily access the relevant and important information on the ongoing clinical trials in the European Union.
Ms. Natalia Farr