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Bethesda North Marriott Hotel and Conference Center

Mar 18, 2014 8:30 AM - Mar 20, 2014 4:00 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Beginning with the End in Mind – Study Endpoints: Targeting Patient-Centered Outcomes

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Overcoming Regulatory Challenges in Targeting Patient-Centered Outcomes in Psychiatric Drug Development

Session Chair(s)

Thomas P. Laughren, MD

Director

Laughren Psychopharm Consulting, LLC, United States

Selecting the primary measure for a definitive trial and defining the primary study endpoint are critical steps in any drug development program. There is increasing interest in using patient reported outcome (PRO) measures in registration trials, and these measures present many challenges, including regulatory challenges. Included among the regulatory challenges are redundancy with investigator rated measures and pseudo-specificity. This talk will discuss possible approaches to overcoming these and other regulatory challenges associated with PROs.

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