Mobile health (mHealth) technology will redefine how we conduct clinical R&D. Consumer-friendly technologies, including remote sensors, wearable devices and mobile apps, offer clinical development access to potentially rich, sensitive patient data that not only complements existing sources—providing a more complete view of therapy safety and efficacy—but may also provide a better understanding of disease.
Clinical studies are exercises in data collection and analysis to determine and prove treatment safety and efficacy. Trial sponsors have traditionally employed physician investigators to collect data from patient-volunteers on their behalf and to assess response to therapies. This visit-based, episodic data, using case report forms and surrogate endpoints like the six-minute walk test, once provided the closest approximation of reality available. Now however, a much closer approximation of reality may be available through the increasing availability of mHealth-driven, patient-direct data.