What about Wearables?
“Wearables,” mobile devices that monitor clinical trial subjects remotely and transmit data, not only reduce costs and make trials more efficient but also offer fuller and more accurate data, reports Debra Michaels, senior scientist at DIA Americas.
Development and use of remote sensors has outstripped regulatory oversight of them. Dr. Bill Byrom, director of product innovation at ICON Clinical Research, says, “This lack of regulation is an area that causes some discomfort. We want to understand if we do use a wearable in a clinical trial, how will we know it’s going to be accepted by the regulators? And as we device endpoints for the outcome data that we choose, how can we provide evidence to show that an endpoint is valid and reliable for use in a clinical trial and a regulatory submission?”
“Because the interest in digital devices, as unique products and combined with drugs and biologics as combination products, has paralleled if not preceded the interest in use of digital devices in clinical trials, CDRH has for many years been on the front lines of responding to the impact of technological changes on medical products,” Michaels explained. The 21st Century Cure Act attempts to address the issue of remote sensors, and the Food and Drug Administration’s Center for Device and Radiologic Health (CDRH) is reorienting FDA policy to conform to the act. In July the center released a Digital Health Innovation Action Plan that addresses issues involving wearables.
One is the security and reliability of remotely-gathered data. The FDA’s interest is to limit access to the data and reliably identify the “source originator,” i.e., the subject, and the subject’s location. The remote device’s security would have to be demonstrated, primarily through the use of encryption.
Clinical trial organizers will have to demonstrate that they have validated the remote device as “reliably capturing, transmitting and recording data to produce accurate, reliable and complete records.”
The FDA has committed itself. In the Digital Health Innovation Action Plan, to finding means of insuring that the data captured and transmitted by remote devices has an actual and valid relationship to the patent population and disease process under study. This goal has not yet been achieved.
In addition to the FDA, a private group, the Critical Path Institute, has also addressed the growth of wearables in clinical trials. Its potentially important Electronic Patient-Reported Outcome (ePRO) offers specific guidance about whether a given sensor is appropriate for measuring a given research goal; whether it is sufficiently precise and accurate; and whether it is reporting the data reliably.
Michaels expects “efforts to reduce barriers to the use of mobile technologies in clinical studies” to “intensify in the near future.” In addition to what they can offer to clinical trials, “their post-market applications, such as assessment of safety and effectiveness of therapies and improvement of quality of care through data for better patient and shared decision making, are important drivers for adoption of these technologies.” She concludes, “The biggest driver of all may be patients, who have embraced mobile technology and expect it to keep improving their lives.”
