NOT ONLY ARE SUPPLIES SCARCE, BUT LABS ARE SUBSTITUTING THINGS IN KITS WITHOUT TELLING US, and if the tubes included are not compatible with the assay being run, there is a risk of ruining samples. One improvement for clinical trials would be a change in the central lab concept. Clinical trial sites are often located in busy academic centers or at a distance from the subject’s home. Allowing the subject to go to a local lab location close to their home rather than the study site lab reduces the burden of travel and logistics for the subject. This should work for most trials. Specialty labs and diagnostics may still need the current cumbersome process. However, the ability to simplify routine lab results reporting without having to create all the local lab info in the data management system would tremendously streamline this process.
MARY ROSE KELLER is VP of clinical operations at Heron Therapeutics. She has 30+ years of industry experience in clinical development strategy and execution.