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The Pharma Perspective · January 15 · 1 hr 15 min

Measuring What Patients Actually Care About | Katja Rüdell | EP 5

In this episode of The Pharma Perspective podcast, Katja Rüdell, one of the world's leading clinical outcome assessment and patient-reported outcomes experts, discusses the role of PROs in drug development, regulatory expectations from FDA and EMA for outcome measure validation, the challenges of developing fit-for-purpose COA instruments, the evolution of patient-centred research in pharmaceutical clinical trials, and best practices for ensuring PRO data meets both regulatory and clinical standards.

0:00-1:15:14

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show notes

In this episode of The Pharma Perspective podcast, Katja Rüdell, one of the world's leading clinical outcome assessment and patient-reported outcomes experts, discusses the role of PROs in drug development, regulatory expectations from FDA and EMA for outcome measure validation, the challenges of developing fit-for-purpose COA instruments, the evolution of patient-centred research in pharmaceutical clinical trials, and best practices for ensuring PRO data meets both regulatory and clinical standards.