Are you ready for the new European clinical trial regulation?

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The new European Clinical Trial Regulation (ECTR) will replace the 2001/20/EC Directivethe directive that currently describes how clinical trials should be conducted in Europe. The main objectives of the new ECTR are to make Europe attractive again for research and development (R&D) initiatives, to create an environment that is favourable for conducting clinical trials, and to encourage more sponsors to conduct trials across the European Union (EU) member states. The regulation will have a major impact on the conduct of clinical trials.

The Regulation will include:

  • More harmonized and efficient clinical trial application procedures;
  • Increased transparency regarding clinical trial data;
  • Provisions that should be considered by sponsors to enhance safety and efficacy of drugs.

The implementation of 2001/20/EC Directive was an important step towards the harmonization of clinical trials in Europe, but as it was still subject to individual member state interpretations there were discrepancies in the laws between countries. This resulted in higher costs for sponsors and long trial start-up timelines. The number of newly registered clinical trials per year in Europe is declining in the past decade. The new ECTR aims to create a uniform framework for electronic clinical trial authorization and a centralized assessment of the application dossier. This will result in reducing duplication of effort and costs. It will also likely lead to improved collaboration, information-sharing, and decision-making between and within EU member states.

The new ECTR No. 536/2014 was released back in 2014 – yet the industry still awaits its full implementation. The ECTR will become effective after the EU web portal and database have been set up. The significant technical complications in the portal and database have delayed the effective date of the new regulation. The completion of a fully functional database will be confirmed by an independent audit that will start in December 2020. Currently, it is expected that the portal and database will go live in December 2021.

The new regulation is applicable for Investigational Medicinal Products (IMPs) for human use and does not apply to non-interventional trials or trials without medicinal products (e.g. devices or surgery). Clinical trials that started before the effective date of the regulation can continue complying with the Directive for three years. After this transition period, all clinical trials should be conducted according to the ECTR.

Key changes in the regulation:

Legislative – The Directive set out a number of requirements for member states to achieve individually through changes in their own national legislations. This resulted in many discrepancies between countries, which will be reduced by the new Regulation.

EU Clinical Trial Portal and Database – A single, unified portal and database for sponsors, health authorities, and ethics committees of all members states will be implemented. The EU portal will be the central platform for sponsors to submit applications and notifications, and is built to allow a one-time submission across the multiple European countries. The regulators can perform their assessments and supervise the trial via the portal, which needs to be used for all related sponsor-regulator communication. The system will be accessible via individual workspaces for sponsors, regulatory authorities and the public. The system will contain collaboration tools, as well as workflow and document management capabilities.

Simplified submission process – The submission of research protocols and other study-related documents will be performed centrally and digitally by all selected member states. The application dossiers will be divided in 2 parts:

  • The assessment of Part 1 includes medical sciences and product rating;
  • The assessment of Part 2 concerns national matters (e.g. information letter for subjects, insurance and privacy aspects).

The timelines for assessments of Part 1 and Part 2 are the same in all member states. In multinational trials, the participating member states will jointly assess Part 1. For each study proposal, one member state is the so-called reporting member state, with the role of providing a summary opinion on Part 1 from all member states, following consultation with the review committee of the other participating member states. The report on Part 1 is applicable to all member states. The assessment of Part 2 will be performed by each member state separately. Based on the selected submission strategy, Part 1 and Part 2 assessments will be performed in parallel or in succession.

The regulation provides defined timelines for the different stages of the authorization process. The review of Part 1 will take maximum 45 calendar days. In case of queries, this timeline will be extended with 31 calendar days. A deadline of only 12 calendar days will be given to the sponsor to answer queries.

Transparency – Study information in the EU database will be publicly accessible, thus increasing transparency. Additionally, the sponsor will be required to publish 2 summary reports within 1 year after trial end: a scientific summary report and a summary report in layman’s language. Personal information that could be used to identify participants or commercially sensitive information will not become public.

How CATO SMS is preparing for the change

The ECTR will have a major impact on the conduct of clinical trials, especially on timelines for trial start-up and milestones (e.g. first-patient-first-visit). For this reason, sponsors will have to prepare when planning a new clinical trial, by taking the 3-year transition time into consideration. In preparation for the ECTR implementation, several guidance documents have been published.

Proactively considering the available guidance documents, the regulatory affairs team at CATO SMS is setting-up the implementation and procedural updates accordingly. During the set-up of new clinical trials according to ECTR, CATO SMS will guide sponsors and provide updated submission strategies in line with the new guidelines and the compressed timelines, crucial for consideration in the planning of new clinical trials. Support in the transition of ongoing trials started under the Directive but requirements to meet the ECTR specifications will also be provided. Lastly, CATO SMS is also well equipped to support writing of the clinical trial summary in line with the ECTR specifications.


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