Operationalizing Radiopharmaceutical Clinical Trials: 7 Key Qualifications for Successful Sites

Over the past decade, advances in ligand targeting, nanotherapeutics, and multimodality bioimaging technology have driven the development of novel radiopharmaceuticals. Designed to selectively bind to specific receptors on or within target cells and locally deliver cytotoxic radioisotopes, these products are commonly used to treat a variety of cancers, including hematologic malignancies, metastatic bone cancer, prostate cancer, neuroendocrine tumors, and breast cancer. Emerging applications for radiotherapeutics include treatment of viral, fungal, and other infectious diseases that
are increasingly resistant to current standards of care.

The radioactive nature of radiopharmaceutical compounds the complexity inherent to site selection and patient recruitment in oncology studies. Moreover, the pool of sites eligible to participate in radiopharmaceutical clinical trials may be smaller than other oncology studies due to the requirement for licenses to handle radioactive materials and specific site imaging equipment. Thus, the approach to site selection and patient recruitment needs to be meticulously vetted and differs from other oncology clinical trials.

In this guide, we explore 7 key qualifications for site selection in radiopharmaceutical clinical trials.