Phase I Clinical Trials: Testing the Physics
Description
In radiation oncology, phase I clinical trials often test the new capabilities of a treatment machine, a novel radiopharmaceutical drug, or an untested clinical indication of radiation therapy. These trials require significant physics investment of time and expertise to ensure that the methodology used can deliver on the clinical intent of the treatment or can test the feasibility of an approach developed by physics. This requires substantial clinical acumen, strong physician partnerships, and a thorough understanding of the clinical trial development process. This session aims to develop the skills and knowledge of physicists in settings where physics support is incredibly vital to the potential success of a trial and ultimately the technique for future clinical trials or adoption. We will first provide an overview of phase I clinical trials design and goals. We then cover three radiation oncology approaches used in phase I clinical trials. These include new devices, radiopharmaceuticals, and new clinical indications in new treatment sites. The goal of this session is to ensure that physicists are well-positioned to serve as expert partners in phase I clinical trials, thereby further expanding the role of radiation therapy.