“Creative uses of technology in conducting clinical investigations have emerged over the previous decade and include advances that have the potential to improve recruitment, participation, and retention of trial participants,” the FDA notice reads. “New technology and communication infrastructure allow for collection of data and communication wherever the trial participant is located, including at his or her healthcare provider’s location, 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 regulator is hoping to receive specific information about how these technologies are being used in trials, how implementation could be encouraged, how patients will be affected and what barriers stand in the way of widespread adoption.
Electronic or written comments must be received by Dec. 28 and can be submitted via the Federal eRulemaking Portal.
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