Description

Exposure-response (E-R) analysis to inform optimal dose in early clinical development of oncology products has traditionally relied on adverse event-based clinician-reported Common Terminology Criteria for Adverse Events. As part of a broader effort to improve dose optimization in cancer drug development, FDA is exploring inclusion of patient-reported outcome (PRO) data into E-R analysis. Rigorous systematic assessment of symptomatic AEs using well-developed PRO instruments could expand available data used to evaluate drug exposure and related toxicity from a patient perspective. This PRO-based approach may be beneficial in complementing traditional safety assessment with a goal to improve current dose selection strategies. The purpose of this webinar is to provide an overview on the FDA’s draft guidance on core PROs in cancer clinical trials, to discuss how PRO-based E-R methods could complement traditional E-R analysis, to discuss development of PRO-based E-R methods, and to hold a live question and answer session on this topic between the speakers and webinar participants.