With the initial release of the Clinical Trial Information System (CTIS) in January 2022, a digital space was created for the implementation of the EU Clinical Trials Regulation (EU CTR) 536/2014, the law governing the conduct of clinical trials in the EU. A period of adaptation and learning ensued as sponsors and regulators adjusted to the nuances of the system for over a year.
During May-June 2023, a public consultation was held with stakeholders to gather insights from the past year. One key finding is that the transparency and associated deferral rules are too complex. The reasons for this are understandable. The goal of these rules, which aimed to strike a harmonious balance between informing patients and protecting their data, is inherently complex and ambitious. The rules are also a moving target and — as will be discussed below — have now moved up to 7 years closer to EMA’s decision to eliminate deferrals for clinical trial information publication.
What Has Changed?
To understand the change, it’s important to consider the two basic categories of clinical trial information submitted to CTIS: structured data fields and clinical trial documents. Structured data fields are populated by sponsors directly in CTIS and impose a consistent, navigable format of clinical trial information. Clinical trial documents include documents needed to safely run and report the results of a clinical trial, such as the protocol, Investigator’s Brochure, and Clinical Study Report.
In the revised rules, EMA has noted that no PPD or CCI should be included in the structured data fields within CTIS, as structured fields are meant for publication.
Prior to the new rule, public release of both categories of clinical trial information could be deferred for varying amounts of time depending on a variety of factors, including the category of clinical trial and document type. These deferral periods may be eliminated by mid-2024. While the full details are more complicated, they can be summarized succinctly as “For Immediate Release”.
Another notable change will be the number of documents to be instantly published on a revised CTIS public website. The publication will be limited to essential documents that are key to the conduct of the clinical trial, e.g., protocol, substantial modifications, etc. It will be interesting to define key documents from Part I and Part II batches of the clinical trial application. The sponsor should prepare and denote the ‘not for publication’ and ‘for publication’ versions in CTIS to facilitate the review and publication process.
When Will This Change Be Implemented?
Implementation of the revised rules is expected by the second quarter of 2024.
What Effect Will the Rule Change Have on Sponsors?
Sponsors should consider how this change might impact their strategy, especially when identifying in-scope documents. They should also consider the redaction of information that could potentially identify a patient, termed as personal protected data (PPD), as well as information that might undermine the sponsor’s economic, competitive, or financial position, known as commercially confidential information (CCI).
For PPD, minimal strategy changes are expected since this data is always redacted before filing. This is typically managed by evaluating a discrete set of identifiers.
The situation with CCI is more complex. Historically, due to resistance against widespread CCI redaction, sponsors often chose to redact only the information that would stay confidential until the end of the deferral period. This approach aimed to secure CCI approval and maximize the deferral duration.
The elimination of deferral periods will change the way sponsors handle CCIs. It’s anticipated that they will favor broader CCI redactions over evaluating short-term or long-term CCIs.
How Should Sponsors Prepare?
Establishing robust processes and standards is essential for effective change management. This principle is especially true when adapting processes and documents in response to evolving regulations, such as the new EU CTR transparency rules. Sponsors should establish the process early in the CTA planning stages by:
- Identifying the disclosure requirements for the countries where you plan to conduct clinical trials.
- Developing and solidifying your standards and processes.
- Ensuring both your internal and external stakeholders receive comprehensive training on the relevant policies and guidelines.
- Outlining responsibilities for each stakeholder through a RACI (Responsible, Accountable, Consulted, Informed) matrix to streamline the submission process.
The significance of clear, concise writing and robust collaboration between writing and transparency teams cannot be overstated. Templates for core clinical documents should include CCI flags and checkpoints to identify content proactively during the authoring and review cycles. Additionally, it’s important to reference other documents where possible, rather than duplicating specific information.
Lastly, assist your teams in understanding and identifying CCI, ensuring all stakeholders are on board before the document drafting stage.
What Can MMS Do to Help You?
At MMS, we take pride in delivering specialized support for revised transparency requirements for EU CTIS redaction, which includes:
- Scoping of clinical documents for immediate publication.
- Redaction of clinical documents within expedited timelines.
- Critical assessment of CCI in documents during the authoring stage of in-scope documents.
- Consulting support to sponsors for CTIS submissions.
- Implementing efficient processes to address the changing regulatory landscape.
To explore how we can support your specific needs and align your strategies effectively, please click here to start a conversation with our experts today.
Authored by:
Ben Kaspar
Senior Director, Regulatory Affairs and Strategic Consulting
Swathi Pandhiti
Associate Director, Regulatory Operations
Raina Agarwal
Associate Director, Clinical Trial Disclosure and Transparency