FDA seeks input on use of health IT and wearable tech during drug and device trials

The FDA is seeking input from stakeholders on the optimal use of new-era technology during clinical trials, including mobile health tools, telemedicine and remote sensors. In the announcement of a new public docket in the Federal Register, the agency touts the benefits of the new tools, saying they enable increased data collection and communication wherever the participant is located, "creating opportunities to overcome geographical and logistical barriers that otherwise might prevent a potential trial participant from participating in a clinical investigation, as well as facilitating the integration of research with clinical care." The agency asks stakeholders to comment on how it can encourage use of the technologies, and special challenges they pose, including possible compromises to patient privacy and data integrity, as well as the potential for those with a low level of computer literacy to be disadvantaged. The FDA seeks to get a better handle on the emerging arena as drug companies in particular aim to use technology to improve clinical trials. Roche recently revealed it will use an internally developed smartphone app to monitor the progress of patients during a Phase I clinical trial of its Parkinson's candidates, and Biogen ($BIIB) CEO George Scangos has said wearable devices are going to "transform the way we do clinical trials," and wants his company to conduct further research on not only wearables, but also ingestibles that collect data from within the body. More

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