Assessing tolerability of cancer therapeutics: A regulatory perspective from the FDA Oncology Center of Excellence.

Abstract

Patient-reported symptoms and functioning are valuable to understanding the tolerability of cancer treatments in clinical trials. Assessment of key side effects, physical and role functioning, and overall side effect bother in trials may be helpful for benefit-risk evaluation and useful to communicate in product labeling. Inclusion of these assessments has been supported in the literature and Food and Drug Administration guidance documents. In this article, the authors provide their perspective on the evolution of how this data has been considered in oncologic therapeutic evaluation and provide context for the research being presented by the National Cancer Institute Tolerability Consortium.