Introduction
As a Freelance Clinical Regulatory Affairs Expert and Study Start-Up Specialist, staying informed about regulatory developments is paramount to ensuring successful clinical trial management. The European Medicines Agency (EMA) has announced the implementation date for revised transparency rules in the CTIS, marking a significant milestone in the clinical research landscape. In this guide, I aim to provide sponsors and colleagues in Contract Research Organizations (CROs) with a comprehensive overview of these changes and practical strategies for navigating the evolving transparency requirements.
Understanding the Revised Rules
The Revised CTIS transparency rules, announced on 05 October 2023, are set to become live in CTIS on 18 June 2024 , marking a significant milestone in the clinical research landscape. These rules introduce several key changes aimed at enhancing transparency and accountability in clinical research. Here's what sponsors and CRO colleagues need to know:
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Focus on Transparency: The revised rules prioritize transparency by streamlining the disclosure process and removing deferral options for certain documents.
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Protection of Confidential Information: To safeguard commercially confidential information (CCI) and personal data (PD), redaction will be utilized in less key documents subject to publication.
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Publication of Documents: Documents, such as Investigator's Brochures (IB) and Investigational Medicinal Product Dossiers (IMPD) and some others, will no longer be made publicly available, alleviating the need for redaction.
Structured Data Publication
Structured data serves as the foundation of transparency efforts by providing standardized information about clinical trials. The publication of structured data follows predefined timelines and criteria based on trial categories and data fields. Here's a comprehensive breakdown:
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Trial Categories: Trials are categorized into three distinct groups:
- Category 1: Phase 1 trials divided in adults and peadiatrics
- Category 2 with integrated phase 1 & 2 trials
- Category 2 & 3
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Publication Timeline: Structured data will be published at predefined timepoints, including key milestones such as (first) MSC decision dates, recruitment updates, and trial completion, to provide stakeholders with timely insights into trial progress and outcomes.
Please refer to the Revised CTIS Transparency Rules for detailed tables.
Document Disclosure
In addition to structured data, certain documents pertaining to clinical trials will be made publicly available to promote transparency and accountability. These documents include protocols, informed consent forms, recruitment materials, and summary reports. The publication of documents is subject to specific timelines and requirements outlined in the revised CTIS transparency rules.
Navigating Historical Trials
For trials submitted before the launch of the new CTIS public portal, sponsors must navigate the unique challenges associated with historical data disclosure. While structured data will be
published for historical trials, documents will not be made available to the public. Sponsors should ensure compliance with data protection regulations and redact any sensitive information before
publication. And NSM and AM applications will not trigger the publication of part I documents.
For transitional trials sponsors should follow the principles of the "Guidance for the Transition of clinical trials from the CTD to the CTR" and submit a redacted version ‘for publication’ only
of protocol, subject information sheet and ICF.
Personal Note
The recent announcement regarding the implementation of the revised CTIS transparency rules marks a significant milestone. With the publication of the Revised CTIS Transparency Rules on 5 October 2024, the focus has shifted towards achieving a more balanced approach between transparency requirements and the practicalities of regulatory compliance.
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Streamlining Transparency Efforts: The decision to prioritize key documents of interest and eliminate deferral functionality represents a pivotal shift. This change not only simplifies the submission process but also reduces the administrative burden associated with maintaining transparency, enabling sponsors and CROs to operate more efficiently.
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Enhancing Operational Efficiency: By streamlining processes and minimizing administrative overhead, these updates aim to enhance operational efficiency within the regulatory landscape. This approach empowers stakeholders to navigate regulatory requirements more effectively, ultimately benefiting both sponsors and patients.