Clinical Trials Regulation: An Overview

Background

On 31 January 2022, the Clinical Trials Regulation (CTR) came into force, repealing the Clinical Trials Directive (2001/20/EC). The CTR aims to harmonize the rules and procedures for clinical trials across the European Union (EU), ensuring a high level of protection for trial participants while promoting innovation in clinical research.

Key Provisions

Scope

The CTR applies to all clinical trials conducted in the EU, regardless of the sponsor's location. Clinical trials are defined as "any investigation in human subjects intended to discover or verify the clinical, pharmacological, and/or other pharmacodynamic effects of one or more investigational medicinal products (IMPs), including the determination of its safety and/or efficacy."

Ethics and Governance

The CTR establishes a robust ethical and governance framework for clinical trials. It requires that all trials be approved by an independent ethics committee (IEC) and that participants provide informed consent before enrollment. The CTR also establishes a European Clinical Trials Information Platform (EU CTIS), which provides a single point of access to information about all clinical trials conducted in the EU.

Data Transparency

The CTR introduces new requirements for the transparency of clinical trial data. Sponsors are required to submit a summary of the results of all clinical trials to the EU CTIS within one year of completion. This data will be publicly available, subject to certain exceptions.

Impact on Sponsors and Member States

The CTR represents a significant change in the regulatory landscape for clinical trials in the EU. Sponsors and Member States should take steps to ensure that they are compliant with the new requirements. The European Medicines Agency (EMA) has published a number of guidance documents to help with implementation of the CTR.

Conclusion

The CTR is a landmark regulation that will have a profound impact on clinical research in the EU. It will help to ensure a high level of protection for trial participants while promoting innovation in the development of new treatments.