mHealth in Clinical Trials: Benefits and challenges

A recent article showed that whilst it is still rare for wearable devices and smartphones to be used in clinical trials there is growing evidence of some major benefits, including:

  • Real-world, continuous measurement of health status as subjects follow their daily routines; opportunities to build richer patient health profiles
  • Accurate measurements to improve patient-reported outcomes (PRO); deliver time-marked data to compare and verify PROs
  • Improvement in subject retention by delivering prompts, encouraging compliance, sharing information; more convenience to encourage research participation
  • Reduced costs by decreasing the need for expensive clinic visits

According to a 2015 SCORR/Applied Clinical Trials survey of CROs and other service providers, mHealth’s greatest benefits will come from improving data accuracy and patient experience. A growing body of research is evaluating mHealth capabilities to improve subject retention and reduce site management costs. With dropout rates as high as 30% and site management costs as high as $2,500 per month,  data collection based on integrated wearable devices and smartphones could reduce site dependence and deliver significant cost reductions.

Drug developers identify five major challenges in the adoption of mHealth technologies in clinical trials:

  • Data security and privacy
  • Data qualification and validation
  • Regulatory acceptance
  • Adoption costs and demonstration of return on investment
  • Implementing mHealth technology on a global scale

Evolving regulation will help drive adoption of mHealth-based research models. In this fast-moving environment, however, regulators are hard-pressed to keep guidance current and industry informed regarding the accepted use of these new technologies in the setting of regulatory submissions and product registration. The U.S. Food and Drug Administration has issued two sets of guidance (in 2014 and 2015, respectively) presenting regulatory views on use of mHealth technologies in clinical trials.  These evolving guidelines, together with regulatory consultation, can help sponsors determine regulatory acceptance of a given mHealth application in a specific trial setting.

During the next five years, mHealth technologies will mature to enable advanced research models, including cloud-based health databases of continuously uploaded patient data and Internet-based trials conducted remotely. This future envisions “mTrials” that use wearable devices, smartphone and tablet apps, and patient-physician interactions via telemedicine to collect accurate data in real time. The immediate challenge is to integrate mHealth technologies into global research processes, and to learn how best to apply and interpret the data tsunami they are about to deliver.

Posted in Apps, Regulation, Security, Software Development, Technology, Validation