LA BioMed and Science 37 have launched their first collaborative clinical research trial and enrolled patients in the first-ever virtual, networked clinical trial using telemedicine to monitor the effects of an infusion medication. The research study will compare the effects of rituximab with another medication called mycophenolate mofetil in treating adults with active pemphigus vulgaris (PV). Pemphigus vulgaris is an auto-immune skin condition that causes your skin to form blisters. LA Biomed is one of more than 60 sites for the PEMPHIX clinical trial, sponsored by Genentech, and the only telemedicine-based site.
Working together, LA BioMed and Science 37 are implementing a groundbreaking research process, using technology to improve the patient experience. Better methods for patients will improve study recruitment and retention, reducing the cost and time needed to complete clinical research.
Dr. Noah Craft, MD PhD, LA Biomed investigator and co-founder of Science 37, said, “We have started the first of what we anticipate will be many networked clinical trials together. My experience as a clinician and a researcher showed me that patients needed ways to participate in research that respected their time and their needs. My experience with telemedicine showed me how to use technology to bring research to people in their own homes.”
Patients will communicate with the research team and participate in the study from home, and through interacting with mobile nurses. The technology and protocols are designed to protect participants’ privacy while reducing the number of visits to the research site.
The trial is being implemented using NORA® (Network Oriented Research Assistant), Science 37’s proprietary application technology. With NORA®, research investigators, nurses, and patients communicate with each other on mobile devices. Patients can enroll, consent, and participate in this trial from home. Investigators and nurses can track and record vital patient information and talk directly with patients via video chat. LA BioMed investigator and Science 37 founder Noah Craft, MD, PhD is licensed to practice medicine and able to enroll patients for this trial from 7 US states covering 23% of the US population.
The research doctors are communicating with patients during home visits using video conferencing and other technologies on a mobile smartphone that is provided to participants. Patients can also call the research team anytime between visits using the same phone. Using this technology means that most study visits will take place at home rather than at a research clinic. During the research study, which will last 2 years, nurses will visit patients at home at pre-scheduled times. In addition, participants will visit the research clinic 4 or 5 times throughout the year.
Science 37 anticipates significant benefit to participants and to study sponsors through the use of its streamlined, patient-centric enrollment and clinical trials management systems.