Accelerated Approval Could Spur Development Of Patient-Reported Outcomes Tools
A subtle takeaway from the Oncologic Drugs Advisory Committee’s March 20 review of GlaxoSmithKline’s Votrient (pazopanib) for treatment of advanced soft tissue sarcoma was that accelerated approval, with a post-marketing requirement to confirm clinical benefit in a difficult-to-treat population, could incentivize sponsors to develop instruments for assessing symptom improvement.
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Linking E-Health Records With Claims Offers Context On Outcomes – Optum Labs Exec
Despite the promise electronic health records hold for comparative effectiveness research, clinical information needs to be lined up with claims data to get a more complete picture, Optum Labs’ William Crown said during the recent Comparative Effectiveness Summit.
Oncology Experience With PROs
There has been some success in getting PRO data into oncology labeling, but also notable failures.
Can Social Media Help Validate Patient-Reported Outcomes? FDA Reviewer Gives “Resounding Yes”
Work needs to be done to allow for the use of social media to support content validity of patient-reported outcomes, but one FDA endpoints reviewer says there is a place for social media to work alongside traditional methods of validating PROs.