Valuing the Patient Voice

By Dr Nicola Davies

As part of its steps to enhance patient engagement, on June 23 2020, the US Food and Drug Administration (FDA) launched Project Patient Voice, a publicly-available website that shares information about patient-reported outcomes (PROs) from cancer clinical trials for marketed treatments.

This pilot project, initiated by the FDA’s Oncology Center of Excellence (OCE), is the first of its kind and will allow insightful PRO data to be more accessible to patients and their healthcare providers. Dr Nicola Davies discusses the increasing value the FDA is placing on the patient voice and how the FDA intends to utilize this voice to inform treatment choices, regulatory decisions, and oncology drug development.