The FDA is looking for input on how mHealth technology might be used to improve clinical trials. In particular, the agency wants to know how healthcare providers and other parties are using consumer-generated data, how they’re reaching out to consumers, and whether the data being collected is useful and reliable.
Here’s what they wrote:
Some of these technologies and methods may be used regardless of the trial participant’s location and may include, for example, mobile health technology, telemedicine and remote sensors. Use of these technologies and methods allows for more flexibility for the sponsor and clinical investigator in the oversight of clinical investigation conduct, data collection and monitoring of trial participants and clinical sites. Other elements that may be incorporated into clinical investigations to improve trial participant recruitment include online/Web-based eligibility screening, informed consent and communication between investigators and participants.
The FDA is obviously looking at ResearchKit-based studies which are popping up all around the place, with major institutions using Apple’s platform with a large number of participants. Beyond studies relying on ResearchKit, there are also those using other devices made by the likes of Google, Fitbit and Jawbone.
The 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 is also looking into projects that collect data from a number of different devices that are owned by study participants, and in that sense it calls this the BYOD (Bring Your Own Device) model for clinical investigations. They want to learn about efforts made by researchers to connect and work with participants who have little to no computer literacy or limited access to mobile technologies.
Everyone can submit his/her comment to the FDA by Dec. 28.
[Via: mHealthNews]