Immuno-oncology (I-0) has emerged as a promising area of research in oncology. The diverse investigational products that are currently under development in both the United States and the European Union target a plethora of biological mechanisms and pose unique challenges for clinical researchers. Innovative trial designs that take into account ethical considerations, adequate data collection and measurements, and the use of biomarkers as predictive or prognostic markers have helped researchers in designing and executing clinical trials that can provide valuable effiacy information. Furthermore, comprehensive planning and risk management in these high risk trials, which can have enhanced and unexpected toxicities, are imperative for the trial’s success and an adequate safety data collection. In this white paper we present in a clear and concise manner study design and execution strategies as well as data collection points and measurements necessary to undergo a successful I-O clinical trial.
Key Challenges and Applied Approaches in Immuno-Oncology Trials
