Telemedicine or telehealth solutions may not be new, but virtual video visits are becoming more common for communication between patients and healthcare providers thanks to COVID-19. In clinical trials, the application of telemedicine technology is still evolving. Clinical trials have far more considerations and challenges beyond the basic patient-clinician interaction. A telemedicine platform intended for clinical trials must provide broader functionalities to accommodate the various needs of sponsors, CROs, patients, clinicians, investigators, research site staff, and regulators, as well as meet international regulatory requirements.
Therefore, medical research sponsors should consider the protocol’s requirements when selecting a video-enabled communication and collaboration platform, carefully distinguishing between a telemedicine solution built specifically for clinical trials and an all-purpose video conferencing platform.
Prominent video conferencing solutions like Zoom or Webex, for example, target the healthcare industry by marketing features like high-resolution video, crisp audio, screensharing with annotations, and video recording. These tools help to facilitate simple, remote patient-physician consultations. However, there are few, if any, features that cater to the specific nuances of medical research, such as shared, encrypted calendars and multi-language support. In addition, these video conferencing tools rarely mention research sites or have any features designed to simplify the workflows for this important stakeholder. Finally, any mention of HIPAA is usually in the context of “compliance” through a Business Associate Agreement (BAA), and supporting documentation is usually rife with ambiguities.
On the other hand, telemedicine platforms designed specifically for clinical research, such as SmartSignals Telemedicine, provide clinical research sponsors with a multi-functional ecosystem to digitize and improve the clinical research process for all stakeholders. These purpose-built platforms improve the patient and site experience as well as help sponsors access a wider, more diverse participant pool through remote or decentralized trials. Other important characteristics that make these solutions ideal for clinical research include:
- HIPAA, HITRUST, and/or SOC 2 certification (not just “compliance”)
- Integration with eCOA, eConsent, or EDC systems as well as medical devices (sensors and wearables, scopes, etc.)
- Multi-party encrypted calendaring
- Training and support by clinical science and medicine experts familiar with clinical trial operations
To help distinguish between the two types of platforms described, we compare Signant’s Telemedicine solution with a generic video conferencing solution in the table below.