Understanding the Impact of EU Clinical Trial Regulation 536/2014

EU Clinical Trial Regulation 536/2014 (CTR) is a new regulation that will govern all clinical trials conducted in the European Union (EU). This CTR ensures greater harmonization of the rules for conducting clinical trials throughout the EU. The CTR came into force on January 31, 2016, and was fully implemented on January 31, 2022. The…

August 29, 2023

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The CTR aims to improve the safety and efficiency of clinical trials in the EU by introducing several new requirements. These include:

A single authorization procedure for clinical trials conducted in the EU, regardless of the number of participating countries
A single EU portal called the Clinical Trials Information System (CTIS) for submitting clinical trial applications
A single decision by the European Medicines Agency (EMA) to authorize a clinical trial
Increased transparency of clinical trials, including the publication of all clinical trial protocols and results
Stronger protection for the rights of clinical trial subjects

A New Era for Clinical Trials

The CTR is a major overhaul of the regulatory framework for clinical trials in the EU. It will have a significant impact on the way sponsors conduct clinical trials in the EU, as well as the way clinical trial data is used and shared.

It replaced Directive 2001/20/EC, or CT Directive, the previous legislation governing clinical trials in the EU. As a directive, each EU member state enacted its national legislation, which has led to complexity and fragmentation in multinational clinical trials. The shift from a directive to a regulation simplifies and standardizes the rules for conducting clinical trials, making the EU a more attractive region for clinical research.

Potential Advantages of the CTR

The CTR offers advantages to sponsors, regulators, and patients, including:

Increased Efficiency

Before the CTR, sponsors had to submit clinical trial applications individually to national competent authorities and ethics committees in each country. This method led to administrative delays and duplication of efforts.

With the CTR, they can now submit a single application for authorization by the EMA to run a multinational clinical trial through the CTIS. This new approach makes it convenient for sponsors to keep track of their applications and for regulators to process them more efficiently.

It also simplifies the authorization process and results in a single decision for all member states involved in the trial. This makes it easier and more efficient for sponsors to conduct clinical trials in multiple EU countries.

Increased Transparency

The CTR increases clinical trial transparency by requiring all clinical trial protocols and results to be published in the EU Clinical Trials Register. This makes it easier for researchers to access and share clinical trial data.

This requirement is a significant step forward in ensuring sponsors conduct clinical trials transparently and with more accountability. It also helps promote the responsible development of new medicines and improves the quality of care for patients.

Enhanced Safety and Public Trust

The CTR strengthens the protection of the rights of clinical trial subjects by requiring that sponsors obtain informed consent from all subjects and provide them with more information about the risks and benefits of participating in a clinical trial.

Sponsors are legally required to electronically report if they experience Suspected Unexpected Serious Adverse Reactions (SUSARs) for any clinical trial conducted in the EU. This requirement helps ensure regulators are notified of any potential safety concerns as soon as possible.

This increased transparency and protection of clinical trial subjects helps enhance public trust in clinical trials.

Navigating the Linguistic Landscape

The CTR requires that all clinical trial information be made available in the languages of the participating countries. The objective is to ensure that trial participants and patients understand the materials and that the scientific content is accurately translated for regulatory authorities.

Translating all clinical trial information can be a complex and time-consuming process. Sponsors must ensure translations are accurate and compliant with the CTR. They also need to keep up with the changing regulatory landscape.

This is where language service providers (LSPs) can help. Working with an LSP for translation of clinical trial information has several advantages:

Domain expertise: LSPs often have teams of translators and linguists with expertise in medical and scientific fields. They understand the complexities of clinical trial terminology and can accurately translate technical content.
Quality assurance: LSPs specialize in accurate translation, ensuring that medical and scientific terminology is translated correctly. They have quality assurance processes to ensure the accuracy and consistency of translations.
Regulatory compliance: LSPs are familiar with these regulations and can ensure that translated documents meet the regulatory requirements of each country.
Scalability: LSPs can handle the translation needs of multiple trials across different languages and regions, making it easier for sponsors to conduct trials in various countries.
Time and cost savings: LSPs have project management processes and translation memory tools that help streamline the translation process, ensuring the timely delivery of accurate translations at a lower cost than in-house translators.

What LSPs Need To Do To Prepare

LSPs that provide language services for clinical trials in the EU need to take steps to prepare for the implementation of the CTR. They should:

Stay updated with evolving CTR regulations and guidelines to provide compliant translations.
Develop expertise in medical and scientific terminology in the context of clinical trials for accurate translations.
Adapt processes to meet new documentation and reporting standards introduced by the CTR.
Implement rigorous quality assurance processes, including expert reviews and adherence to norms.
Familiarize themselves with language and formatting requirements for clinical trial submissions across EU member states.
Collaborate closely with pharmaceutical sponsors and Contract Research Organizations (CROs) to align with project needs.
Build relationships with regulators to stay up to date on the latest changes to the regulatory landscape.
Use translation memory tools for consistent language use and efficient workflows.
Implement robust data security measures due to the sensitive nature of clinical trial data.
Upskill staff to ensure they have the skills and knowledge necessary to accurately and compliantly translate clinical trial information.

By taking these steps, LSPs can help ensure they are ready to support clinical trials in the EU under the CTR.

Work With Welocalize

Welocalize Life Sciences has over 20 years of experience providing clinical trial translation and interpreting services to sponsors, CROs, and medical device manufacturers. Our team of professional, native-speaking translators and interpreters has medical degrees and experience in the target therapy or device. We offer translation and cross-cultural adaptation services into over 250 languages for use in global clinical studies.