A recent commentary by Peter Pitts of the CIOMS patient engagement working group warrants further discussion. He makes excellent points about the need for meaningful patient data, but highlights the institutional roadblocks and questions that linger about the benefit of patient engagement in medical product development. In reality, the roadblocks are real, and it will take sophisticated change management to overcome existing barriers to make patient engagement a ubiquitous reality in the medical products industry.
Read MoreThere are dozens of terms being used in the patient-focused policy space. I try to make sense of some of them, but a cohesive policy framework would help create consistency around how we describe patient-focused data and policy activities.
Read MoreModern patient engagement regulatory policy has its origins in the HIV/AIDS advocacy movement. Legislation in 2012 provided FDA with the power to initiate several new patient-focused initiatives. There has never been a better time for the patient voice to be heard by regulatory decision-makers.
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