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Patient Preference Data: Pfizer’s Tanezumab Study Had ‘Flaws’ That Made It ‘Uninformative’

 
• By Sue Sutter

Study showed osteoarthritis patients are more willing to accept risk of joint damage with NGF-inhibitors than dependency associated with opioids, Pfizer said; however, FDA highlighted key flaws in study design, sample population and survey content.

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Osteoarthritis patients in Pfizer's study said they were more willing to risk joint damage than dependence on opioids. • Source: Shutterstock

Pfizer Inc.’s unsuccessful attempt to use patient preference information (PPI) to sway the US Food and Drug Administration’s view on tanezumab should be a lesson for other sponsors on appropriate study design, particularly when an investigational product has a challenging benefit-risk profile.

Pfizer offered results from a preference study showing patients with moderate to severe osteoarthritis are willing to risk some level...

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