Navigating the Complexities of Radiopharmaceutical Trials: Insights from Jim Lincoln of Aixial Group

At the recent COG New England meeting in Burlington, MA, Jim Lincoln of Aixial Group presented on the Trial Considerations for Radiopharmaceuticals. Jim, Sr. Director of Clinical Operations & Project Management at Aixial Group, shed light on the unique challenges and critical factors for success in conducting clinical trials involving radiopharmaceuticals.

Jim emphasised the importance of detailed and specific site feasibility assessments, ensuring interdisciplinary alignment on process flows, and understanding site standard practices for administering investigational medicinal products (IMPs). He also highlighted the need for trial sponsors and CROs to possess expertise in navigating regulatory submissions, particularly in the face of limited guidance and lack of global harmonisation of guidelines and regulations for radiation safety.

A key takeaway from the session was the crucial role of site support, including providing comprehensive training, defining reconciliation processes for central lab samples and imaging, establishing clear data entry expectations, and facilitating communication among site interdisciplinary teams. Jim stressed the significance of early engagement with imaging, central labs, and dosimetry vendors to ensure they understand study and site requirements.

One of the most pressing challenges in radiopharmaceutical trials, as pointed out during the session, is the "race against the clock" due to the time-sensitive nature of IMPs with short half-lives. To address this, he recommended dedicating logistics coordinators to effectively manage the supply chain, conduct "dry runs" to sites, and maintain close communication with site teams to manage patient scheduling and visit-specific requirements.

Jim also discussed the importance of mapping out all visits during screening to work within visit windows, understanding capacity limitations, and ensuring sites are trained on and understand the IMP quality control process.