DIA Global Clinical Trial Disclosure and Data Transparency Conference

Untangle the complexities of global disclosure practices, learn about recent regulatory modernization, and discuss cross-regional strategic considerations.

Listen as Raina Agarwal, Associate Director of Clinical Trial Disclosures at MMS presents the following:

Accelerating Clinical Trials Publication by Proactively Protecting CCI: Adapting to EU-CTIS Revised Transparency Rules 

The implementation of the revised transparency rules in EU-CTIS on 18 June 2024 has significantly affected sponsor decision-making during pre-submission activities.  Sponsors find it difficult to prepare both internal and external stakeholders for the demands of the process including: consistent authoring and messaging around endpoints reporting, redaction of confidential information across submission documents throughout the life-cycle of the study, and use of the CTIS portal to manage evolving transparency requirements.  

In this session, we will discuss our real-time experience working on EU-CTIS submissions under non-deferral strategies, collating concerns from sponsor teams, project planning, timelines and trends observed in additional redaction criteria for CCI in several Part I and Part II documents (eg. Protocols, ICFs etc.).  We will also share practical scenarios to approach the redaction of clinical study reports and reporting of summary results for ‘Trial results’ sections for new and transition studies.   

We will provide best practices to be right the ‘first time’ for acceptance of in-scope documents in EU-CTIS submissions.  Key takeaways will emphasize on the importance of: 

• Updating working practices based on the most recent regulations for transparency rules 

• Upgrading templates for in-scope documents (eg. ICFs) 

• Lean clinical documents in context to CCIs 

• Upgrades to redaction quality control checklists to safeguard concrete CCIs 

• Consistent reporting of details in plain language protocol synopses vs results 

• Consistent redaction of information across submission documents in alignment with other possible sources of information (eg. Public Registries) 

• Proactive review of CCIs from transparency experts 

• Documenting lessons learned from agency queries 

• Stakeholders’ engagement 

The presentation will provide advice on CTIS submission planning, enhancing process efficiency, and liaising with the agency during the initial 6 months of adoption of revised rules.