Incorporating Patient Perspectives into Structured Benefit-Risk Assessment: A Drug Development Framework...

Area of Science:

• Pharmacovigilance and Drug Development
• Regulatory Science
• Patient-Centered Research

Background:

• Regulatory bodies advocate for integrating patient perspectives into benefit-risk assessments to align decisions with patient needs.
• Current methods primarily rely on patient-reported outcomes from clinical trials, lacking a systematic approach.
• A need exists for comprehensive frameworks to incorporate patient insights throughout the drug development lifecycle.

Purpose of the Study:

• To propose an expansion of the Sullivan et al. structured benefit-risk (sBR) assessment framework.
• To enhance the systematic inclusion of the patient perspective across all stages of drug development.
• To foster a patient-centered approach in regulatory decision-making.

Main Methods:

• Review and analysis of existing benefit-risk assessment frameworks.
• Building upon the 2023 Sullivan et al. sBR assessment framework.
• Developing recommendations for integrating patient perspectives at each drug development phase.

Main Results:

• Identification of gaps in current systematic benefit-risk (sBR) assessment regarding patient input.
• Proposal of an expanded sBR framework incorporating patient perspectives throughout drug development.
• Recommendations for a more patient-centered drug development lifecycle.

Conclusions:

• Systematically incorporating the patient perspective into benefit-risk assessment is crucial for patient-centered drug development.
• Expanding existing sBR frameworks can facilitate a more comprehensive inclusion of patient insights.
• This approach aims to improve treatment outcomes and enhance patients' lives.