Leveraging Programmatic Collaboration for a Radiopharmaceutical Clinic.

Simple Summary: Until recently, radiopharmaceuticals have been underutilized for the curative or the palliative treatment of cancer. Advances in a development program with investigational agents that have a radioactive payload as part of the studied drug product necessitate new ways of drug handling and administration as well as novel logistics for a safe and satisfactory patient experience. This review offers a roadmap for the clinical start-up and implementation of an integrated and leveraged programmatic collaboration for an academic theranostic center. Within this roadmap, there are complex issues of logistics, coordination, medical considerations, radioprotection, receipt and waste of radioactive agents, and patient release priorities. Regulatory agency input also adds to the layout dynamics of the theranostic center, but this roadmap does not cover specific requirements as United States state laws differ considerably. Radiation oncologists, radiopharmacists, nuclear medicine physicians, and medical oncologists have seen a renewed clinical interest in radiopharmaceuticals for the curative or the palliative treatment of cancer. To allow for the discovery and the clinical advancement of targeted radiopharmaceuticals, these stakeholders have reformed their trial efforts and remodeled their facilities to accommodate the obligations of a program centered upon radioactive investigational drug products. Now considered informally as drugs and not beam radiotherapy, radiopharmaceuticals can be more easily studied in the traditional clinical trial enterprise ranging from phase 0–I to phase III studies. Resources and physical facilities allocated to radiopharmaceuticals have brought forth new logistics and patient experience for safe and satisfactory drug delivery. The clinical use of theranostic agents—that is, diagnostic and therapeutic radionuclide pairs—has accelerated radiopharmaceutical development. [ABSTRACT FROM AUTHOR]