Day 2 – Wednesday, February 26, 2025 - ET (Eastern Time, GMT-05:00)
Uncover steps in transforming existing data into powerful insights and drive groundbreaking results.
- Discussions on reusing clinical data
- Obtaining more precise patient populations
- Setting cutting-edge standards for secondary use in clinical trials.
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.
- Lauren Haggerty - Clinical Trial Results Manager II, Bristol Myers Squibb
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
- Jenny Petersen - Director, Clinical Trial Disclosure and Transparency, Alnylam
- Regulatory Compliance
- Best practices in implementing transparency policies
- Challenges in overseeing and meeting global disclosure obligations
- International Regulatory Impact on Data Transparency
- EMA Policy 70 -- implications for global workflow
- Patient-Centric Approaches to CTD
- Transparency in rare disease and orphan drug development
- Miscellaneous
- Effective communication with regulators
- Data quality assurance in CTD
- Clinical Document Disclosure
- Addressing backlog post-restart of Policy 0070
- Health Canada PRCI: harmonizing with EMA (joint submissions, anonymization report, feedback structure, EMA acceptance of Health Canada submissions.)
- Redaction and anonymization techniques
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.