Abstract:

EU CTR harmonizes the process for assessment and supervision of clinical trials in the European Union. This new regulation requires sponsors to use a technology platform called Clinical Trials Information System (CTIS). CTIS supports more efficient evaluation and authorization of clinical trial applications but it will require changes to trial sponsors’ processes. Key stakeholders (regulators, sponsors and CROs) would benefit from learning more about how sponsors’ initial experiences with the regulation and CTIS.

This cross-sectional study will use structured interviews to evaluate sponsors’ experience in four areas:

· Impact of EUCTR on existing processes (transition from Directive to Regulation)

· Alignment across functions and departments

· Initial experience with the regulation

· Challenges and mitigation strategies

10 sponsors have been invited to participate. The results will be presented during PHUSE Data Transparency Summer Event

Abstract:

The EU Clinical Trials Regulation (CTR) requires the publication of many documents submitted during the clinical trial lifecycle. Personal and commercially confidential information must therefore be protected through disclosure control methods such as redaction or anonymization.

Novel technological and methodological solutions are required to operationalize a scalable disclosure control pipeline for documents in scope of EU CTR, ensuring that compliance and privacy protection are maintained for the transformed documents.

While anonymization may be used for clinical study reports submitted post-marketing authorization, aligning with other international document disclosure requirements, the scope and regularity of document submissions especially in the trial setup and execution phases creates new scalability challenges. This will likely drive greater reliance on redaction as the most efficient method of protecting confidential information and participant privacy.

Here we will describe how AI/ML approaches combined with redaction and anonymization can help sponsors navigate the new transparency landscape under EU CTR.

Abstract: To follow

Abstract:

With the implementation of the CTR in Europe and continued proliferation of global regulations, pharmaceutical organizations are assessing their clinical anonymization strategies for regulatory and voluntary disclosures. Study sponsors should embrace a holistic and consistent approach to disclosure that considers efficiency and consistency in support balancing risk of re-identification with the wide ranging requirements including company policies, regulatory compliance and internal and external sharing.