Considerations for the attribution and management of toxicities in phase I clinical trials

The process of describing the association of adverse events with investigational drugs in clinical research is known as symptom attribution. The focus of attribution varies and in early phases of drug development, the use of attribution data is predominantly used for safety assessment and ensure patient protection. The current symptom attribution process is often not easy and has a number of limitations and challenges. In this review, we review the current status of attribution in the context of early-phase studies, highlight some of the limitations and challenges, and expand on future directions and the number of actions that may improve the efficiency of the attribution process in clinical research. This review includes the discussions, challenges and recommendations from the consensus-building workshop on toxicity attribution (Silver Springs 2017) to develop guidance for improving attribution of adverse events in Oncology.