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Mobile Health, Telemedicine, and Remote Sensors in Clinical Investigations: A New Era in Clinical Trial Design?
Session Chair(s)
Leonard Sacks, MD
Director, Clinical Methodologies,Office of Medical Policy, CDER
FDA, United States
This forum will discuss opportunities for mobile technologies in clinical trials, which could facilitate the measurement of novel patient-centered endpoints, decrease geographical access barriers for patients, and drive efficiencies for sponsors.
Learning Objective : Discuss opportunities for novel endpoints, lower access barriers, and increased trial efficiencies from the use of electronic technologies and remote study data collection; Discuss examples of technologies which could change the way some clinical trials are conducted; Describe how technology could facilitate subject enrollment and study conduct regardless of geographic location.
Speaker(s)
Panelist
Matthew Kirchoff, PharmD, MS
FDA , United States
Program Management Officer, Office of Medical Policy, CDER
Panelist
Ken Skodacek
FDA , United States
Deputy Ombudsman, Clinical Trials Program, ODE, CDRH
Panelist
John Marler, MD
FDA, United States
Medical Officer, DNP, Office of New Drugs, CDER
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