FDA seeks comments on mHealth in clinical trials

From the mHealthNews archive
By Eric Wicklund
09:45 am

The success of Apple's ResearchKit platform in the clinical trial space has caught the attention of the U.S. Food and Drug Administration.

In an Oct. 29 notice published in the Federal Register, the FDA is seeking input on how mHealth technology might be used to improve clinical trials. The agency is particularly interested in 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.

[See also: ResearchKit on stage at HIMSS Connected Health Conference]

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"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," the FDA wrote in its notice. "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."

Launched in April on the heels of its wildly successful, consumer-facing HealthKit, ResearchKit was Apple's first provider-facing platform, aimed at giving health systems, researchers and others in the space a means of collecting consumer data from any location and at any time. While it began with five programs – targeting Asthma, Parkinson's disease, cardiovascular disease, diabetes and breast cancer - dozens of clinical trials and projects have since sprung up, using the ResearchKit base and connecting with everything from iPhones to the Apple Watch. More recently, researchers have started developing projects around popular health and fitness devices from the likes of Google, Fitbit and Jawbone, as well as wearable sensors and home-based monitoring devices.

"(The) FDA is soliciting public input from a broad group of stakeholders regarding technologies and innovative methods for using technology to more efficiently conduct clinical research," the notice reads. "(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."

[See also: Apple ResearchKit: Can patient-generated data be trusted?]

Among the issues being targeted by the FDA are methods for improving consumer engagement in clinical trials, identifying barriers – perceived and real - that keep certain populations from participating, the success or failure rates for different types of technology, specific conditions or populations that benefit from the use of mHealth technology, and methods for ensuring the integrity of data used in the studies.

The FDA is also looking into projects that collect data from a number of different devices – calling this the BYOD model for clinical investigations – and efforts made by researchers to connect and work with participants who have little to no computer literacy or limited access to mobile technologies.

Comments are due to the FDA by Dec. 28.



[See also: ResearchKit becomes a population health tool]