Tuesday, July 16, 2024

Clinical Trials Transparency Boosted by New CTIS Rules in the EU

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The launch of a new version of the Clinical Trials Information System (CTIS) provides earlier and more efficient access to clinical trial information in the European Union (EU). This change, effective today, follows the adoption of revised transparency rules. These rules eliminate the deferral mechanism that allowed clinical trial sponsors to delay publishing certain data for up to seven years. As a result, approximately 4,000 clinical trials with issued decisions are now publicly accessible through CTIS, and the portal will add around 500 newly authorized clinical trials per month.

The updated rules strike a balance between transparency and the protection of commercially confidential information. They benefit patients by providing early access to key clinical trial information. Clinical trial sponsors benefit from process simplifications, while healthcare professionals gain easier access to clinical trial data and potential treatment options. Several resources, including user guides and dedicated support activities, have been created to help sponsors understand and comply with the revised rules.

The revised transparency rules were adopted by the European Medicines Agency’s (EMA) Management Board in October 2023 after a public consultation. CTIS serves as the single entry point for clinical trial applications in the EU, including a public searchable database for transparency. The European Commission oversees the implementation of the Clinical Trials Regulation, ensuring that the system meets the high standards set by the regulation. The transparency rules are designed to protect public health while also considering the legitimate economic interests of sponsors.

Revised CTIS Transparency Rules Simplify Access to Clinical Trials Information in the EU

CTIS has been operational since January 2022 and is based on Article 81 of the Clinical Trials Regulation (EU) No 536/2014 (CTR). It includes a public interface that meets the requirements for protecting personal data and commercially confidential information (CCI). The transparency rules are based on the premise that information in the EU database should be public unless specific justifications for confidentiality are met, such as protecting personal data or commercially confidential information, ensuring effective supervision of clinical trials, or maintaining confidential communication between Member States.

Since the launch of CTIS, feedback from users and the public has highlighted the need for revised transparency rules. The changes aim to simplify the system while maintaining high levels of transparency. The revised rules remove the deferral mechanism and focus on the publication of clinical trial information that is most relevant to patients and researchers. This includes trial design details, product and sponsor information, and clinical trial results.

The revised rules also streamline the publication process, making it less complex and more user-friendly. This approach is intended to improve the experience for users and reduce the burden of redactions while still providing essential information to the public. The rules were revised following an eight-week public consultation held in mid-2023, which received feedback from 204 stakeholders, including sponsors, academic institutions, and patient organizations.

Clinical Trials

New CTIS Rules Enhance Clinical Trials Transparency and Simplify Data Access

The new CTIS transparency rules include publishing clinical trial information relevant to patients and researchers, simplifying the information on the CTIS public website, and reducing the complexity and workload for users. The revised rules ensure that clinical trial documents, including protocols and summary results, are published much earlier than under the previous system. Structured data fields populated by sponsors in the CTIS include trial title, study design, inclusion and exclusion criteria, primary and secondary endpoints, and details of the investigational medicinal product.

These fields cannot be redacted, so users must ensure no personal data or CCI is included. Documents to be published will be redacted to protect CCI and personal data as needed. The simplifications introduced by the revised CTIS transparency rules aim to guarantee faster and more efficient access to clinical trial information. Following adoption by the EMA Management Board, the new transparency rules will be implemented in the CTIS system, including its public portal. The EMA plans to finalize the implementation by the second quarter of 2024, and the effective date of the new rules will be communicated to CTIS users in due course.

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Resource: European Medicines Agency, June 18, 2024

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