mHealth
Virtual clinical trials represent a relatively new method of collecting safety and efficacy data from clinical trial participants, from study start-up through execution to follow-up.
Adam Amdur, Chief Patient Officer of the Sleep Apnea Association launched the SleepHealth mobile app study, the first large-scale observational sleep study that leverages mobile health to collect real world data.
Limited use of “Bring Your Own Device,” or BYOD, in regulatory studies to date is mainly due to industry concerns spanning two areas.
This article surveys several pressing regulatory topics that clinical trial researchers need to consider when using mHealth technologies, including good clinical practice (GCP), fitness of use, security/privacy, electronic records (and eSource data), researcher oversight, and inspection preparedness.
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