Leveraging Patient Reported Outcomes in US Oncology Labels

In the current oncology treatment landscape, optimizing symptom management and quality of life have become critical considerations alongside survival outcomes. Patient-reported outcomes (PROs) provide critical insights into disease symptoms, treatment toxicities, and their impact on quality of life as directly reported by the patient.

PROs are collected in most oncology clinical trials and submitted to Health Authorities and Health Technology Assessment bodies to inform their assessment of benefit/risk. While this is an important step towards including the patient voice in oncology drug development, the full potential of these PROs has not been realized, as they are rarely accessible to healthcare providers and patients. During this episode, industry experts Marina Robin, PharmD (Labeling Strategy Manager, Astrazeneca), and Allison Guy (Sr Regulatory Affairs Director, AstraZeneca) will explore the label as a pathway for improving access to this data.

What You'll Learn 

• The current state of PRO data collection and utilization in oncology drug development, including current challenges with label inclusion
• Strategic advantages of label inclusion versus alternative PRO dissemination pathways
• Insights from regulatory guidance and label precedents that can be used to inform future PRO strategies

Who Should Attend

Professionals working in oncology drug development teams and those who are seeking to enhance patient-centricity (i.e., Regulatory Affairs, Labeling Strategy, Clinical Development, Patient Safety, Medical Affairs, or Commercial)

Speakers:

• Marina Robin, PharmD - Labeling Strategy Manager, AstraZeneca
• Allison Guy - Senior Regulatory Affairs Director, AstraZeneca