One of the biggest promises of mobile health apps and wearables is the sheer amount of data they collect. As that dataset grows, a number of different stakeholders are taking an interest in it, among them patients themselves, doctors, and clinical researchers. The latter is the focus of from the Duke-Margolis Center for Health Policy.
“Under a collaborative agreement with the [FDA’s] device center, Duke Margolis formed an expert working group to look at a particular subset of mHealth, and that is patient-generated health data collected through these mHealth apps and wearables,” Mark McClellan, director of the Center, said in a call with reporters. “To emphasize here, this effort is not about evaluating the wearables or apps themselves, for their fitness for medical use, but rather the fitness of data coming from these mHealth sources to evaluate other medical products — to perhaps have a fundamental effect on clinical trials and the development of real-world evidence on medical products going forward.”
In the report, the Center presents five recommendations for the industry around using mobile health apps and devices in clinical trials.
The first is to establish a learning community around mobile health research.
“We recognize there are a number of groups — mHealth companies, patient groups, academic groups as well — all doing important and relevant things right now,” Center Deputy Director Greg Daniels said on the call. “But there isn’t one spot, a virtual community where all of these groups can go to and share what they’re learning, get best practices, and develop new partnerships to learn more and figure out where evidence gaps are, how best to design this technology, and how best to use mHealth data for research purposes.”
The Center further recommends that the research community should be organized around four goals: improving patient engagement; improving physician engagement; establishing shared criteria for when a device is “fit for purpose” for a given intervention; and developing methods and tools for using and analyzing the data.
The second recommendation is also about working together to improve things for the whole industry. In this case, it’s about creating shared tools and resources for mobile health developers and companies that they can use in pre-competitive stages of growth.
The third recommendation is to support the establishment of standards for collection, transmission, and analysis of patient-generated data. That includes being aware of the biases data can bring with it, Daniels said.
Fourth, the Center suggests using mobile technologies to communicate back to the participants in a research study to keep them better informed of the progress of the study, and even to share preliminary or final results where appropriate.
“Researchers can promote sustained engagement in research by learning how to communicate more effectively with participants,” the report explains. “This could include periodic acknowledgment that the participant’s data have been received, providing information on the progress of the study, and sending a meaningful and understandable explanation of the study results.”
The fifth and final recommendation is to use mobile health to improve recruitment for studies and to streamline the informed consent process.
This report comes at a time when the FDA is taking a serious interest in real-world evidence, thanks to provisions in the recently passed 21st Century Cures Act.