CTIS go-live is just around the corner. The new portal brings a new approach to clinical trials in the European Union: digitalization, improved efficiency, increased transparency, enhanced patient safety… and a huge adaptation process for sponsors and researchers. A lot of work is to be done right away!
The European clinical trial scenario is about to undertake a major change. It will all happen (or start to happen) next year. On January 31st, 2022, CTIS will go live, dramatically changing the way clinical trials documentation is managed within the European Union. As you may already know, the Clinical Trial Regulation (536/2014) was released in 2014, but it will only come totally into force once the Clinical Trial Information System (CTIS) goes live next January.
The Regulation harmonizes the assessment and supervision processes for clinical trials throughout the EU, via CTIS. The new platform will contain the centralized EU portal and database for clinical trials foreseen by the Regulation. It will provide simplified end-to-end electronic application procedures over the life cycle of clinical trials across Europe.
There is no doubt that CTIS will bring great opportunity to clinical research in the EU – once it is fully working – but there is a lot to be done in order to comply with the new regulation and take full advantage of CTIS functionalities.
Clinical trials in phases I to IV, as well as low-intervention clinical trials, being commercial or non-commercial, are under the scope of the European Union CTR. So, there is a lot to be done for the pharmaceutical and biotech companies that are conducting clinical trials in the EU.
The big issue here is whether these organizations – such as pharmaceutical laboratories, SMEs, academia, research organizations, and other clinical trial sponsor organizations – are ready or not for CTIS.
A new approach to clinical trials in Europe
EU Clinical Trial Regulation (536/2014) aims to bring a better harmonization for clinical trials submission process within Europe, together with unnecessary cost reduction, due to the current existence of multiple ways of submitting documentation (being based on each countries’ legislation).
The goal is to make European Union a more attractive place for clinical research. No wonder coordinated assessment for multinational clinical trials is one of the benefits CTIS will for sure bring once it is implemented. In addition, it will engender a more efficient framework for the submission and assessment of clinical trial applications within established deadlines.
Nevertheless, Member States will maintain their autonomy since there will be a coordinated submission along with a non-centralized authorization.
What is new regarding the submission process and documentation management
The aim of the new Regulation is to achieve three main objectives:
- Digitalization and improved efficiency.
- Increased transparency.
- Enhanced patient safety.
- Support to Innovation & Research
Following the mentioned goals, CTIS implementation will bring:
- A single EU entry point for clinical trials information
- Exclusive telematic submission process through CTIS
- Presentation and communication between stakeholders: Investigation Ethics Committees, Member States, and Sponsors. The exchange of information between sponsors and the Member States will be fully electronic in CTIS.
- Improvement of public data available concerning clinical trials application and results: CTIS will offer searchable clinical trial information to the patient, the healthcare professional, and the general public. Clinical trial results will be available both as a technical summary and in lay language.
- CTIS facilitates a harmonized safety assessment in Europe, supported by agreed assessment report templates.
After CTIS go-live in January 2022, there will be a three-year multiple phase transition period.
Clinical trial documentation is currently being recorded in EudraCT database. During the first year (2022), clinical trials can be submitted under the old Directive or under the new Regulation (CTR 536/2014).
During years two and three (2023 & 2024), clinical trials authorized under the old system remain under that system, however new clinical trials must be submitted via CTIS.
At the end of year three, hence, at the end of December 2024, ongoing clinical trials firstly submitted to EudraCT will need to be migrated to CTIS.
Transition period strategy
Setting up a strategy to implement CTIS within your organization should be one of your first steps towards clinical trials harmonization in Europe. Fostering an early implementation, no longer after than last quarter of 2021, will be for sure a winning strategy.
Thus, the question is: Are you ready for the migration of your clinical trials to CTIS? For example, if you have 200 clinical trials ongoing, expected to continue after December 2024, you will need to migrate those to CTIS.
If you plan to submit a new clinical trial during 2022, and it is expected to continue after December 2024, my recommendation would be for you to submit it through CTIS in the first place. That way you will avoid complex and expensive migrations.
The new portal will bring a necessary new approach to clinical trials in the European Union. Its implementation will be very positive for clinical research, bringing digitalization, improved efficiency, increased transparency, enhanced patient safety… and a huge adaptation process for sponsors and researchers. A lot of work is to be done right away!
Lidya Domínguez, BS
Lidya Domínguez’s working years have always been related to clinical research. She is graduated in nutrition and human dietic and master coursed in project management and several expert courses in Clinical Trials and Regulatory Procedures. She is the Head of the Clinical Research Department at Sermes CRO, an International Contract Research Organization with headquarters in Madrid, Spain. Oncology and cellular and advanced therapies are amongst her main therapeutic experience, but during her large experience in pharma, he has worked within several TA, such as endocrinology, vaccines, infectious diseases, etc. She is an expert in European Clinical Trial Regulation. She is part of EMA’s 15 people working group since 2017 for the development of the new European clinical trials portal, CTIS (Clinical Trial Information System).