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Patient-Driven Drug Development Requires New Transparency Policies

 
• By Sue Sutter

If advocacy groups are going to play a greater role in drug development, they need more access to sponsors' data and interactions with the US FDA, and more information about how the agency uses patient preference data, Parent Project Muscular Dystrophy rep says.

The increased role of the patient voice in drug development highlights the need for more transparency into sponsors' clinical data, their interactions with FDA and how the agency uses patient preference evidence in the drug review process, one advocacy group believes.

As the patient community takes on more responsibility for generating patient preference data, FDA should re-examine its policies on how such data are introduced in the review process and provide...

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