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Welcome To The Estimand: Patient-Reported Outcome Framework Gets Warm Response At FDA/ASCO Workshop

 
• By Bridget Silverman

Estimand structure is part of effort to generate standard principles and analyses for patient experience data in oncology and beyond.

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The US Food and Drug Administration and the American Society for Clinical Oncology’s fourth annual workshop on clinical outcome assessments in cancer clinical trials introduced an estimand framework that is designed to ensure “that the research question we want to answer is answerable once the data is collected.”

The estimand framework “provides a structure so that all stakeholders are speaking a common language,” FDA materials summarized. The agency...

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