Colin G. Miller
The use of imaging endpoints in clinical trials has steadily increased over the last 30 years. Often that means that an imaging core lab (ICL), also sometimes called an “imaging CRO,” will be involved. When that’s the case, biopharma companies are in the position of needing to manage and rely heavily on an entity whose operations they know little about. Inadequate knowledge of imaging in clinical trials and ICLs can lead to problems for sponsors. They can be avoided when sponsors work with the imaging experts at TBG to advise them and serve as a knowledgeable intermediary with their ICLs.
The Challenge for TBG
While the typical sponsor’s team is not expert in imaging, the typical ICL team is not expert in biopharmaceutical development. With expertise in both imaging and biopharmaceutical development, the TBG team bridges the gap in knowledge between sponsors and ICLs, allowing the two to communicate eﬀectively and work together efficiently.
A Case in Detail
In one recent case, a sponsor had a study underway with an ICL when an interim analysis revealed that the quality of the ICL’s work was inadequate. The sponsor pulled the study from that ICL and engaged with a second. Unfortunately, in time concerns developed surrounding the second ICL as well. At this point, the sponsor came to us at TBG for input.
Acting as an intermediary between the sponsor and the second ICL, we were able to identify the fundamental problem as one of communication. In our initial conversation, we provided the critical guidance that corrected the situation and put the sponsor on the path for success with its ICL.
Our guidance touched on challenges including the imaging charter, the number of readers to employ, how readers should be trained, various considerations for read design, and more.
The TBG Solution
ICLs have a preferred system and approach that may not ideally align with the sponsor’s needs and endpoints. TBG can objectively evaluate the ICL’s recommendations and procedures and advise sponsors when and where changes should be made. When sponsors work with TBG, they secure an ally and an advocate, one that brings world-class expertise in imaging to the table, and one that ICLs can respect.
TBG Services and Deliverables:
There are numerous services that TBG might provide on the subject of imaging. The earlier that sponsors engage with us, the more we can do and the greater impact we can have. Subjects and areas that can benefit from our attention include:
• Protocol development, including optimizing endpoints
• Imaging charters
• Imaging guidance documents
• Reader training
• The clients were supported by an "embedded consultant" who understood their imaging endpoint.
• Without having to employ staﬀ, the clients enjoyed the beneﬁts of having an imaging expert on "their side.
• TBG consultants saved the client time and money and simpliﬁed the read design, helping to ensure results were available on time for the NDA.
Clients who engage with us at TBG can be conﬁdent that they will receive the expert guidance required to successfully work with an ICL and leverage imaging in their clinical trials, avoiding setbacks, delays, unnecessary expense, and frustration.