Optimal COA Measurement Strategy in Modern Oncology Trials

In this white paper, Signant’s in-house experts share key takeaways from recent FDA draft guidance on the use of patient-reported outcome measures (PROMs) in modern oncology research, and share essential considerations for optimal COA measurement strategy, including proper PROM selection, implementation, and administration.

Readers will learn the core domains that the agency values the most when reviewing oncology PROM data and how to derive the best endpoints to support regulatory decision-making and labeling, as well as suggestions on how to balance the frequency of PROM administration with patient burdens. Read more at the link below.