Posted 28 October 2015
By Zachary Brennan
The US Food and Drug Administration (FDA) on Wednesday announced it's looking for more information on technologies and innovative ways to more efficiently conduct clinical research.
The use of smartphones and tablet devices to collect trial participant data seems to be of particular interest to FDA as it's requesting more information on the challenges associated with collecting data on trial participants' own devices, which FDA says may be used to access and respond to study-related questionnaires.
"FDA is interested in identifying new opportunities to study medical products, as well as receiving comments on barriers, challenges, and relevant considerations that may affect a medical product clinical investigation that uses these technologies and methods," the agency said.
But the agency isn't just interested in the tech-savvy future, it also wants to hear about the challenges or special considerations with recruiting and/or retaining trial participants "with low levels of computer literacy or individuals who may have limited or no access to mobile technologies, computer devices, or the Internet."
More specifically, the agency said it's "aware of several groups conducting and interested in conducting clinical investigations using mobile technology and remote methods for data collection."
FDA is seeking feedback on industry experiences with implementing such methods or models, including lessons learned, as well as information supporting the use of any suggested technologies, methods, or models, including any characteristics that would make the technology more or less desirable for use in clinical trials.
As the for informed consent process, FDA is curious as to the perceived barriers or challenges to obtaining and documenting it, or obtaining institutional review board review, approval, and oversight for clinical investigations in cases where new technology is used.
Using Technologies and Innovative Methods to Conduct Regulated Clinical Investigations of Investigational Drugs; Establishment of a Public Docket