Quality of life in oncology drug approvals: evidence from Swiss decisions in relation to global regulatory trends

Key Points

• The aim is to examine the quality of life (QoL) reporting in oncology drug approvals in Switzerland and its alignment with global regulatory practices.
• Analyzed oncology drug submissions from Swiss regulatory authorities.
• Assessed reporting on health-related quality of life (HRQoL) domains.
• Evaluated the integration of HRQoL in statistical analysis plans by pharmaceutical companies.
• Increased HRQoL reporting, predominantly focusing on physical health.
• Notable underreporting of broader HRQoL domains.
• Limited regulatory utility due to incomplete data and analysis plan issues.

Abstract