As the life sciences world undergoes increasingly rapid digitization, sponsors are transforming their development processes to stay competitive. The next logical step is to conduct clinical studies virtually, delivering them directly to patients in the comfort of their own homes. This paper examines the three critical keys to success.
By easing the patient burden of traveling to sites for multiple visits and tests, removing geographic and logistical constraints to participation, and using electronic data capture and real-time information access, early adopter studies have demonstrated more rapid patient enrollment, higher retention, better data quality and overall faster cycle times.
Technology is the common denominator that underpins this emergent ability to successfully conduct virtual research. In these trials, virtual investigative teams connect with patients via smart, connected devices. In fact, all of the many stakeholders—patients at home or elsewhere, investigators and team members in clinical settings, home health nurses, and local health care providers (e.g. imaging specialists, lab professionals)— are supported via a robust technology platform to receive and house study documents, conduct analytics, communicate with other stakeholders, host tele-visits and coordinate study workflows.
CRITICAL SUCCESS FACTORS FOR VIRTUAL TRIALS TECHNOLOGY
Bringing the entire clinical process online is a challenging feat requiring sophisticated orchestration of multiple interoperable elements. Over the past three years, technologies—including fit-for-clinical-purpose cloud computing, clinical-grade connected devices, robust teleconferencing, sensor data access, advanced analytics and integrated, secure platforms—have matured sufficiently to be configurable into a robust reliable solution. Such platforms, tools and devices are now near-foolproof, with data integrity ensured. However, they must be fully integrated to provide a seamless online experience with full connectivity for all participants.
RELIABILITY AND PERFORMANCE EXCELLENCE
Virtual trials extend far beyond simple data collection. They require a robust network of tools to support various engagement opportunities. For example, participants and stakeholders may use a videoconference tool similar to FaceTime, for meetings, smart connected devices such as tablets or smart phones for alerts and survey responses, and mobile health devices including blood pressure monitors and spirometers to automatically collect health measures from patients. This network of solutions enables the necessary quality and ease of communication, storage and transmission of data, and more streamlined work flow coordination and documentation.
Of necessity, these technologies must be robust, reliable, clinical-grade and consistently perform at the highest levels. Virtual trials platforms rely on cloud computing to provide scalability in terms of geographic dispersion, high performance tele-visits and more data points than with traditional trials. These platforms must be interoperable, connecting seamlessly with other virtual trials systems and devices as well as parts of the traditional trial ecosystem, such TMF or safety databases/event reporting to comply with pharmacovigilance regulations.