Patient-Centered Real-World Evidence Framework for Oncology Product Development.

Area of Science:

• Oncology
• Real-World Evidence (RWE)
• Health Outcomes Research

Background:

• Real-world evidence (RWE) is increasingly used in oncology.
• Existing RWE guidelines lack a clear definition and framework for patient-centered RWE (PCRWE).
• There is a need to incorporate patient perspectives into oncology RWE.

Purpose of the Study:

• To propose a practical methodological framework for patient-centered RWE (PCRWE) in oncology product development.
• To define PCRWE and guide its research in the oncology field.
• To address the unmet need for integrating patient voices in RWE.

Main Methods:

• Literature review of existing RWE guidelines.
• Development of a preliminary PCRWE framework based on literature findings.
• Finalization of the framework through interviews with RWE stakeholders and oncologists.

Main Results:

• A novel definition of PCRWE was established.
• A practical, interactive visual framework for PCRWE in oncology was developed.
• The framework accommodates varying user expertise and aligns terminology.

Conclusions:

• The proposed PCRWE framework provides a structured approach for oncology product development.
• It enables stakeholders to identify patient-relevant unmet needs.
• The framework facilitates the demonstration of new oncology product value from a patient perspective.