Participant Data Return Survey Results
Participant data return is the act of granting clinical trial participants access to the data that was collected about them during a clinical trial. In current clinical trial practice, we take measurements, conduct tests, and perform procedures. The results are reviewed by the investigator and stored by the sponsor, but participants rarely see their own results.
Category: Working Groups News
Summary of the Panel Discussion on the EMA CHMP Clinical Study Data Submission Pilot at the PHUSE US Connect 2025
At the PHUSE US Connect 2025, I had the opportunity to moderate a panel featuring representatives from the European Medicines Agency (EMA), Genentech, PHUSE and others, focused on the evolving future of data submissions in the EU.
Category: Events Across the Globe
PHUSE Data Transparency Autumn Event 2025 Summary
The Data Transparency Autumn Event 2025 brought together 519 attendees spanning 140 companies and 25 countries. With discussions on evolving policies, the ethical responsibilities of data sharing, the challenges of privacy and risk management, and AI and innovation, the event offered a rich mix of perspectives and expertise, with Q&A sessions fueling thought-provoking discussions.
Category: Events Across the Globe
Statistical Strategies for Quality by Design under ICH E6(R3)
Quality by Design (QbD) is a systematic approach to product development, particularly in pharmaceuticals and clinical trials, aimed at ensuring that quality is built into the design, conduct and monitoring of a study from the outset. The ICH E6(R3) Good Clinical Practice (GCP) guideline introduces a framework that promotes flexibility in study conduct, modernisation of trial approaches, and greater efficiency in clinical trial execution. Statistical elements are central to achieving these objectives.
Category: Industry Topics
