mHealth technology – the practice of collecting and managing medical data using phones, tablets and other mobile devices – seems poised to flood the clinical research industry like never before: Pharma companies, CROs and academics all recognize the potential of these technologies to improve clinical trials, and regulators are signaling their approval by taking action on new guidelines for their use. There’s general agreement that the next few years will see the widespread adoption of mHealth technology and other methods of remote data collection, much to the benefit of trial patients, sponsors and public health. At Medrio, these vibrations have not gone unfelt. Site staff and patients are entering clinical data and PRO responses using our mobile tablet apps; Medrio users can send PRO surveys to patients via email so that patients can fill them out remotely at their own convenience.
So what’s happening with regulators and mHealth thought-leaders?
Survey says: mHealth wave is coming
It seems sponsors and CROs increasingly see mHealth as a potentially simpler, more convenient, and more patient-centric means of monitoring and data collection. Surveys show companies involved with clinical research recognize the benefits of mHealth and are incorporating it more fully into their plans. Results from a Knect365 survey published in May 2017 show that 94 percent of companies in the drug development sector are looking to increase their use of mHealth technologies in clinical trials in the future. According to another set of surveys from SCORR Marketing and Applied Clinical Trials, 95 percent of clinical trial industry insiders believe the positives of using wearables in clinical trials outweigh the negatives.
How regulators are paving the way
The private sector isn’t the only place where mHealth in clinical trials is starting to take hold: The FDA, in conjunction with several other entities, has started to lay the regulatory groundwork necessary to make the mHealth revolution as smooth as possible. In July 2017, the FDA released the Digital Health Innovation Action Plan (DHIAP) to share its vision for regulating a variety of medical software. Included on the agenda: issue legislation to increase exemptions and clear up the approval process for mHealth apps and other electronic systems, and invest in digital health talent to create a pool of expertise and mHealth specialists to consult on best practices.
To promote the use of mHealth for research on medical treatments, the Duke-Margolis Center for Health Policy (DMCHP)—a non-profit that works with policymakers—collaborated with the FDA to release an mHealth action plan last September . The plan offers substantial guidance on the use of mHealth in clinical trials, identifying opportunities for outcome collection and the types of data that can be collected. And last June, the Clinical Trials Transformation Initiative (CTTI), a partnership between pharma companies, academics, and regulators, offered their own set of recommendations for the use of mHealth in clinical trials.
The mHealth guidance from the DMCHP plan, the FDA’s DHIAP, and the CTTI should help lead to innovation and faster approval practices. It’s also a sign that as private companies make plans to ramp up their use of mHealth in clinical trials, regulators are preparing along with them.
Clearly, the time for app-accompanied clinical trials has come. By increasing the speed and convenience of data collection and shortening trial timelines, mHealth technology is poised to help change the drug development process for the better.