Clinical Trial Transparency and Disclosure Regulations
The Clinical Trial Regulation known as EU CTR and more fully as CTR EU Regulation No 536/2014 serves as a replacement for Clinical Trial Directive using EudraCT (following a transition period). According to the EMA the EU CTR has the following objective:
The EU CTR aims at creating an environment that is favourable for conducting clinical trials in the EU with the highest standards of safety for participants and increased transparency of CTs information. It will replace and expand the scope of the existing EU Clinical Trials Directive 2001/20/EC.
The regulation aims to benefit Authorities (member states, Ethics Committees, etc.), Sponsors and the General Public including patients, scientists, HCPs, media, citizens.
The European Clinical Trials Directive (2001/20/EC) was a European Union (EU) directive that governed the conduct of clinical trials in the EU. The directive was adopted in 2001 and came into effect in 2004, replacing a patchwork of national rules that existed across the EU. The aim of the directive was to harmonize the rules for clinical trials across the EU and to ensure the protection of the rights, safety, and well-being of trial participants.
The Clinical Trials Directive required that all clinical trials in the EU be authorized by the competent authorities of the Member States in which the trials were to be conducted. It also established a series of requirements for clinical trials, including the requirements for obtaining ethical approval, informing participants of the trial, monitoring the trial, and reporting adverse events.
The Clinical Trials Directive was widely criticized for being overly complex and bureaucratic, and for slowing down the process of conducting clinical trials in the EU. In response to these criticisms, the EU adopted the Clinical Trial Regulation (CTR), which replaces the Clinical Trials Directive and came into effect in 2016. The EU CTR aims to simplify and streamline the process of conducting clinical trials in the EU, while maintaining high standards for the protection of trial participants.
The EU CTR imposes much more reporting than the CTD. In addition to safety reporting, sponsors must notify each Member State through the EU portal (CTIS) about the start of the trial, the end of recruitment, the end of the trial in all countries worldwide, and other information. Moreover, sponsors must submit a summary and lay summary of the results, an annual report on safety for each IMP, and, if the data are used for regulatory purposes, the clinical summary report (within 30 days of the granting of marketing authorization).
The EU CTR goes further than CTD to facilitate increased transparency through the EU portal. All clinical trial-related documents and information going through CTIS are meant to become public. Exceptions, however, will apply, such as for personal data or commercially confidential information. This last concept, which has been the subject of intense debate in recent years, will have the same meaning as it has under the EMA’s current policies on access to public documents and to clinical trial data (known as “Policy 0070”)
The operational implementation of the EU CTR began in January 2022. There are three key timeframes to be aware of regarding EU CTR.
The transition period for the Clinical Trial Regulation (CTR) is a period of time during which clinical trials that were ongoing under the previous European Clinical Trials Directive could be completed or transitioned to the new regulatory framework established by the EU CTR. The transition period was designed to allow sponsors to complete their trials without disruption and to give Member States time to implement the new regulations.
The transition period lasted for three years and ended on January 31 2023. After this date, all new clinical trials had to comply with the EU CTR and be authorized and supervised in accordance with the new regulatory framework established by the EU CTR.
The transition period was an important phase in the implementation of the EU CTR, and it allowed the EU to transition smoothly to the new regulatory framework for clinical trials. By the end of the transition period, all clinical trials in the EU were subject to the EU CTR and its provisions for the protection of trial participants, the authorization and supervision of trials, and the reporting of adverse events.
Clinical trial applications submitted before January 31 2023 are able to under the CT Directive (CTD) until January 31st 2025 at which time they must be transitioned from Eudra CT into the CTIS. New trial applications submitted after 31 January 2023 fall under CTR and must be submitted using CTIS. At this time new trials can no longer be submitted using Eudra CT. Sponsors anticipating their trials in EudraCT will complete after January 30, 2025 should plan to transition their studies to CTIS anytime between today and January 30, 2025.
The Clinical Trial Regulation (CTR) applies to all clinical trials conducted in the European Union (EU). The EUCTR replaces the previous European Clinical Trials Directive and governs the conduct of clinical trials in all EU Member States, including Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, and Sweden.
Unlike the CTD , EU CTR is binding in its entirety and is applicable in EU/EEA Member States: the 27 EU countries listed above as well as Iceland, Liechtenstein and Norway. The United Kingdom does not fall under EU CTR following Brexit.
The CTR applies to both interventional and non-interventional trials and covers both medicines for human use and medical devices. The regulation applies to all clinical trials that are initiated in the EU, as well as trials that are initiated outside of the EU but are conducted on EU territory.
In short, the EU CTR applies to all clinical trials conducted in the EU, regardless of their origin, with the aim of ensuring the protection of the rights, safety, and well-being of trial participants and promoting innovation in the development of new treatments.
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