Radiopharmaceuticals: Unique Challenges for Clinical Trials and Data Management

Radiopharmaceuticals sit at the intersection of personalized medicine and nuclear science, offering both diagnostic and therapeutic applications. Their unique properties—short half-lives, just-in-time manufacturing, and strict timing requirements—create technology; operational and data management complexities not seen in traditional clinical trials. As personalized treatments, these trials represent the new paradigm in clinical trials to which teams managing all of the above need to rise up to meet the unique specificities.

This session will explore the distinctive challenges of radiopharmaceutical trials and present strategies for managing multi-source data, regulatory compliance, and operational logistics. Key challenges include:

• Supply chain precision: Short-lived isotopes require real-time tracking and seamless integration of shipping data with the eClinical landscape
• Data integration: Imaging, laboratory, pharmacokinetic, and dosimetry data must be harmonized across systems with precise timestamp alignment.
• CRF & protocol design: Standard forms often fail to capture isotope-specific variables, causing delays in database lock.
• Regulatory complexity: Overlapping oversight from FDA/NRC (US) or EMA/Euratom (EU) demands structured capture of calibration, dosimetry, and radiation safety documentation.
• Vendor & site management: Multi-vendor workflows and site staff unfamiliarity with isotope-specific procedures create reconciliation and query challenges.

Using real-world examples from ITM’s experience in radiopharmaceutical trials, this session will provide insight to attendees into this new and exciting area of personalized therapy development and the unique solutions that data managers need to consider.