Abstract
Radiopharmaceutical therapy (RPT) directs radioactive compounds to malignant cells. Incorporating RPT into clinical trials will require practical treatment guidelines for therapy applications which can be applied by institutions in a uniform manner. Quality assurance (QA) centers support clinical trials by providing site qualification, clinical trial design support, clinical trial credentialing, data acquisition/management, and case review. Successful execution of cancer clinical trials requires participating sites to have tools and personnel to successfully deliver therapy in a consistent manner including the ability to generate composite dosimetry with previous sites of radiation therapy for outcome analysis. Assuring RPT is administered uniformly will require implementing a QA program. Quantitative assessment of the radiation dose delivered to the cancer target volumes and surrounding normal tissue(s) will be essential for the QA process to secure the position of RPT in patient care. This paper reviews the status of clinical trials for RPT therapy and defines what a QA process may require for future clinical trials. For RPT to move forward in clinical trials at an enterprise level, a QA program is necessary to optimize how RPT can integrate with established therapy and align with current cancer management. In this manuscript, we define and propose a practical QA program for modern clinical trials in RPT.