Imaging as Infrastructure: Why Sponsors Must Rethink Oversight in Modern Trials

At DPHARM, we spoke with Paul McCracken, founder and principal of RadiaNova Consulting, about the overlooked pitfalls in clinical trial imaging and how evolving radiopharmaceutical studies are redefining imaging’s role.

McCracken highlighted that sponsors often underestimate protocol deviations in imaging and, more critically, fail to detect these issues until it’s too late. He pointed to data showing up to 30% of oncology imaging datasets were initially unusable, leading to costly delays or rework — and in one MR study, 50% of data had to be discarded altogether.

He argued that imaging should be treated as a protocol-critical endpoint, not just a downstream data stream. Sponsors, he said, tend to engage imaging vendors too late, missing the opportunity to design imaging requirements — like equipment, timing, and workflows — into the study from the start.

As radioligand therapies and theranostic trials grow, McCracken noted that imaging has become foundational to operations. Beyond endpoint measurement, imaging now supports patient selection, dosimetry, and safety — demanding more integration and oversight.

McCracken emphasized the industry’s Achilles’ heel: data traceability. Incomplete audit trails and manual PDF workflows expose sponsors to regulatory risk. He underscored the importance of immutable provenance and recommended AI tools be fully transparent — not “gray boxes” — with logic that can be audited and validated.

He concluded by naming “first-pass, on-time readiness” as the key performance metric for imaging systems: over 85% of imaging data should be read-ready and query-free within 48–72 hours to ensure true clinical value.