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PatientsLikeMe Developing Platform To Validate Patient-Reported Outcomes

 
• By Gregory Twachtman

While the primary objective will be to help members of the online patient community better manage their health, the new platform will offer an opportunity for pharmaceutical companies to validate patient-reported outcomes that they develop, something that could be useful as PROs gain more traction in the FDA review process.

As patient-reported outcomes (PROs) become more prominent in FDA reviews, a new initiative by the online patient community PatientsLikeMe, with funding from the Robert Wood Johnson Foundation, could offer a platform for pharmaceutical companies to validate PRO measures.

The primary goal of this initiative, which is being developed under a $1.9 million grant, is to build a platform to generate meaningful PRO measures “to be utilized by patients...

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EMA: ‘Sad To See’ Member States Against Patient Engagement Under EU Pharma Reform

 
• By Eliza Slawther

The European Medicines Agency’s chief medical officer Steffen Thistrup argued that patients are able to understand the “complex regulatory and scientific issues” that the EMA committees discuss when they assess drugs.