Join Navigant director Scott Thiel and Verrill Dana attorneys Emily Chi Fogler and Andrew Rusczek as they present "A Fitness Check for Mobile Technology Trials: Select Challenges and Pitfalls."
A growing number of clinical trials investigate or incorporate mobile technologies, and the interest of both industry and academic researchers in identifying ways to use these technologies to monitor, assess, and help manage individuals’ health status has never been higher. However, including a smartphone app or a fitness tracker in a trial may be easier said than done. Appropriate and productive use of these technologies in the context of research requires attention to management of the resulting data and an understanding of its reliability, as well as appreciation of human subject, privacy and security, and other regulatory considerations. Trials involving sites outside the U.S. present additional issues in these regards.
This presentation will describe selected key challenges and pitfalls associated with use of mobile technologies that can delay, derail, or undermine a trial. These include:
Identifying whether a technology constitutes a medical device;
Accounting for potential limitations on reliability of collected data;
Addressing privacy and other rights of trial participants (which may differ across jurisdictions); and
Understanding human subject protection requirements and adapting commercial standards to the research context.
The speakers will present the challenges from regulatory, industry, and institutional perspectives and will discuss strategies for addressing them. Anticipation of the challenges and understanding of the multiple perspectives is critical to development of “fit and healthy” study processes and to successful trial planning and implementation.