The new EMA Clinical Trial Information System (CTIS)

What is the CTIS?

The CTIS supports the flow of information between clinical trial sponsors, European Union (EU) Member States, European Economic Area (EEA) countries and the European Commission [1]. It supports interactions between clinical trial sponsors (researchers or companies that run a clinical trial and collect and analyse the data) and regulatory authorities in the EU Member States and EEA countries, throughout the clinical trial [1]. It replaces the EudraCT forms and will be used for all data regarding a clinical trial (e.g. clinical trial application, safety reporting, modifications, results) [4].

Streamlining data management

The new CTIS is designed to streamline the complex process of managing clinical trial data. Traditionally, clinical trial data management involves various stakeholders, including research groups, pharmaceutical companies, researchers, ethics committees and regulatory authorities, each working with different sets of data and documentation. This can result in delays, errors and inefficiencies, hindering the progress of clinical research and drug development. The CTIS aims to change this by providing a centralised platform where all relevant parties can access and submit trial-related information. This eliminates redundant data entry and minimises the risks of inconsistencies, ultimately leading to more accurate and reliable data. By ensuring that all stakeholders are on the same page, the system promotes collaboration and reduces the administrative burden associated with data management. Therefore, the CTIS offers an end-to-end fully electronic process over the life cycle of a clinical trial [1]. Member States benefit from tools for collaboration and coordination, while clinical trial sponsors can submit, manage and report on a trial in one single place throughout the whole process [1]. The CTIS allows flexibility to submit dossiers in parts and provides easy access to structured data and documents on clinical trials for patients, healthcare professionals, scientists and the general public [1].

Transparency

Transparency is a cornerstone of ethical and responsible clinical research. The CTIS addresses the need for transparency by making information publicly accessible. Detailed information about ongoing and completed clinical trials, including trial design, endpoints, methodology and results, will be available – not only at the approval stage, but throughout the development process. Not only is this important for clinical trial sponsors, researchers and legal authorities, but it also empowers patients to make informed decisions, e.g. about participating in clinical trials [1, 4]. The CTIS has a searchable public website where anybody can view information held in the CTIS on clinical trials in the EU and EEA [1]. The CTIS serves to implement EU pharmaceutical law in the Clinical Trials Regulation [Regulation (EU) No 536/2014] [1]. The EMA maintains the CTIS and the public website, together with the EU Member States, EEA countries and the European Commission [1].

Accelerating drug and data development

The CTIS introduces a more efficient and speedier clinical trial submission and assessment process by implementing a single clinical trial application dossier and harmonised and simplified electronic application procedures for all Member States. Moreover, real-time access to trial data and results enables regulatory authorities to make more informed decisions regarding drug approval and market authorisation, potentially reducing the time required for regulatory reviews and getting new treatments to patients faster. Moreover, the system facilitates the sharing of information and details across the pharmaceutical industry, and researchers can also learn from the successes and failures of other trials, enabling them to make adjustments and refinements to their own studies. This collaborative approach may lead to faster identification of effective treatments and more efficient allocation of resources. New definitions like “low-intervention studies” (studies with already authorised investigational products) enable a risk-based approach with, for example, simpler submission and monitoring [1, 4].

Compliance and data security

The CTIS has incorporated stringent measures to protect sensitive clinical trial information. This system adheres to strict data protection regulation, safeguarding patient privacy and ensuring compliance with international standards. Access to the system is controlled and monitored, and only authorised individuals can view specific information based on their roles and responsibilities. Training must be performed and, for example, roles of high-level administrators must receive EMA approval [1, 3, 4].

Benefits and challenges

To reiterate, the CTIS is a unique digital tool for harmonised submission, evaluation, supervision and storage of structured data and documents on clinical trials in the European Union [5–6]. It provides an end-to-end fully electronic process, the tools for collaboration and coordination, and public access during the entire developmental process of a drug or clinical trial [5–7].

An article by GCP Central discussed what had initially been learned during 2022 by both sponsors and Member States when working with the CTIS, including with respect to compliance with the EU CTR and diverse issues identified as requiring resolution before the end of January 2023 [8]. The EMA has set up a structure to ensure that all users are supported when using the CTIS and that any further identified issues are resolved. A CTIS forum has been created to allow direct exchange of information and discussion of the CTIS user experience [1, 3, 7, 8]. The main issues to date relate to structure, user management and functionalities. The EMA is continuing to work to address these challenges and to support users in using the CTIS.

How to get started?

Training and supporting materials are available from the EMA to help users of the CTIS to comply with their legal obligations [1]. For information on the CTIS, the Clinical Trials Regulation and EMA's online training modules for CTIS users, see [1] and [3] . It is important that all study groups are aware of the existence of the CTIS. Early adoption of the platform by study groups will foster collaboration in Europe.

References

1. European Medicines Agency. Clinical Trials Information System. https://www.ema.europa.eu/en/human-regulatory/research-development/clinical-trials/clinical-trials-information-system.
2. EMA’s Clinical Trials Information System (CTIS) goes live. https://www.ejprarediseases.org/emas-clinical-trials-information-system-ctis-goes-live/.
3. European Medicines Agency. Clinical Trials Information System: training and support. https://www.ema.europa.eu/en/human-regulatory/research-development/clinical-trials/clinical-trials-information-system-training-support.
4. Khera A, Bly S. European Pharmaceutical Review. Understanding the new EU Clinical Trial Regulation: seven things sponsors should know. European Pharmaceutical Review 2022. https://www.europeanpharmaceuticalreview.com/article/168043/understanding-the-new-eu-clinical-trial-regulation-seven-things-sponsors-should-know/
5. European Medicines Agency. CTIS key benefits. 2021. https://www.ema.europa.eu/en/documents/presentation/presentation-ctis-benefits-sme-academia-clinical-trials-information-system-ctis-training-fsweeney_en.pdf.
6. Key points in the CTR transition of clinical trials. Voisin Consulting Life Sciences. https://voisinconsulting.com/resources/blog/key-points-in-the-ctr-transition-of-clinical-"https://voisinconsulting.com/resources/blog/key-points-in-the-ctr-transition-of-clinical-trials/.
7. Nelson A, Kacha R, Pajic T, et al. Clinical Trial Information System: overview, opportunities and challenges. https://www.ppd.com/wp-content/uploads/2022/01/Regulatory-Rapporteur-2022-01-EU-CTR.pdf.
8. GCP Central. EU CTR and CTIS: First learnings from working with CTIS and when known issues will be solved. 2022. https://gcpcentral.com/gcp-central-news/eu-ctr-and-ctis-first-learnings-from-working-with-ctis-and-when-known-issues-will-be-solved/.