Developing a robust Patient-Reported Outcomes (PRO) and Clinical Outcome Assessment (COA) strategy is a multifaceted process with many critical elements to consider. Each step, from identifying relevant outcomes to ensuring compliance with the regulatory and HTA requirements, demands meticulous planning and specialized knowledge.

 

To assist you in this complex journey, Sarah Donelson, Kate Williams, Sarah Acaster, and Jenya Antonova developed a practical tool that can be used as a worksheet for strategy development.

 

This tool is designed to guide you in crafting a comprehensive and effective PRO and COA strategy.