Clinical trials aim to prove that a treatment is safe and effective for patients in improving how they feel, function, or survive. In recent years, the FDA has emphasized the importance of incorporating the patient voice into drug development and the expectation that Sponsors submit Patient Experience Data (PED) to support regulatory decision-making¹. Patient Reported Outcome (PRO) instruments are commonly used as evidence of treatment benefit when that effect is best measured from the patient’s perspective².

The question many researchers must ask is: How do you capture accurate information from patients that cannot easily or reliably self-report? Perhaps they are suffering from a condition that prevents them from accurately reporting their disease experience – such as dementia – or they are not capable of reporting for themselves due to verbal or physical limitations or level of cognitive development.

Join IQVIA's Patient Centered Solutions (PCS) panel of experts as we discuss the following topics:

• Understanding the regulatory framework and methods to capture PED in clinical trials
  • What is PED and how do you collect it?
  • Self-reporting factors to consider
  • Approaches to overcome barriers to self-report
• Capturing PED when self-reporting is not possible
  • How to best work with clinicians and caregivers to understand patient journey and outcomes
• Integration of PED into clinical research
  • Practical case studies that showcase strategies to manage barriers to self-report and optimize the quality of PED

¹_{Public Law 114 - 255 - 21st Century Cures Act}

² _{FDA Patient-Focused Drug Development Guidance Series for Enhancing the Incorporation of the Patient’s Voice in Medical Product Development and Regulatory Decision Making | FDA}