Day 2 – Wednesday, February 26, 2025Wednesday, 26 February 2025 - ET (Eastern Time, GMT-05:00)

• Explore a step-by-step 100-day framework to evaluate your organization’s clinical trial disclosure maturity.
• Uncover strategies for leveraging a self-assessment approach to identify gaps, achieve quick wins, and create a roadmap for long-term improvement.
• Gain actionable insights into building foundational capabilities that align with global compliance and transparency standards.

Join us for an in-depth exploration of the transformation of Plain Language Summary (PLS) production at BMS. This presentation will include a 1-year follow-up experience, providing insights into the progress and impact of our initiatives over the past year. We will delve into the complexities and challenges of managing PLS production and methods for optimizing operational processes to enhance productivity and outcomes. We will also discuss the integration of AI technology in the PLS writing process, its benefits, and limitations.

Finally, we will look ahead to continuous learning, improvement, and advanced AI integration, all aimed at maintaining a patient-centric approach and ensuring high-quality, accessible clinical trial information.

Engage in a comprehensive discussion on various elements surrounding utilization of AI in PLS and patient communications.

• Unravel the complexities and risks involved with implementing AI
• Evaluate the essential role of human involvement in daily operations

This panel discussion will address several critical aspects of clinical transparency processes and regulatory compliance. The Sponsors will share experiences related to their respective viewpoints on qualitative vs quantitative anonymization methodologies, how they transitioned from one methodology to the other, decision points regarding insourcing and outsourcing clinical transparency business functions, applied techniques for anonymizing adverse event, medical history and sensitive terms found in clinical documents and processes for identifying and redacting confidential information.

• Driving Value from Transparency Policies: Explore how clinical trial transparency policies can foster value to the health care ecosystem.
• Introduction to the EFPIA Anonymization Gradient: Highlight the tool’s design and role in guiding sponsors on how to tailor anonymization to the context of the data being shared, preserving privacy and research utility.
• Customizing Datasets for Research Success: Demonstrate how the Anonymization Gradient can help sponsors adjust anonymization controls to meet the specific needs of researchers, enabling them to fulfill their statistical analysis plans effectively.

Explore essential strategies to improve patient understanding of clinical research. Join us as we delve into patient data management and discuss innovative approaches to delivering individual results directly to patients.