Transparency Life Sciences, a clinical-stage drug development company based on open innovation, has enrolled its first patient in a new ulcerative colitis trial designed to assess the feasibility of replacing most conventional patient site visits with data collected using a combination of decentralized methods, including digital measurements, telemonitoring, remote video visits with clinical trial staff and blood collections by visiting nurses. In addition, the study is the first to allow key clinical endpoint assessments to be made by the subjects’ own gastroenterologists, rather than via designated sub-investigators affiliated with the trial.
The study is being conducted in collaboration with Brigham and Women’s Hospital, a teaching affiliate of Harvard Medical School and a founding hospital of Partners Healthcare. It will compare conventional and decentralized data collection in patients who also have volunteered to test the potential benefits of a special dietary intervention, the Combined Anti-Inflammatory Diet (CAID), which has shown promise in earlier studies.
Site visits for patient data collection are the most costly and burdensome clinical trial activity. The growing availability of remote monitoring technologies reduces the need for site visits, offering the potential for substantial cost savings, reductions in participant time and travel, gains in patient safety, and increased quality, quantity and relevance of clinical data. This study also is replacing investigator-conducted invasive assessments of a key outcome measure, the widely used Mayo Score, with assessments conducted by community-based gastroenterologists, further reducing the need for centralized visits.
Principal Investigator Joshua R. Korzenik, M.D., director of the Crohn’s and Colitis Center, division of Gastroenterology, Hepatology and Endoscopy at Brigham and Women’s Hospital, said, “Increasingly, empowered patients and the wide availability of digital monitoring technologies give us the opportunity to reimagine how we conduct clinical trials, with the goal of making them more informative, effective, safe, affordable and inclusive. In addition, we believe that this is the first time that key invasive clinical assessments such as the Mayo Score are being conducted by subjects’ own physicians, which saves time and resources, but more importantly, sets the study in the context of patients’ ongoing care. Ulcerative colitis is a disabling condition with limited treatment options, so we welcome the chance to participate in the development of new approaches intended to facilitate clinical development of more drug candidates.”
Subjects participating in this open-label trial choose whether they prefer to participate in the conventional on-site patient study arm or the remote study arm using decentralized data collection alternatives. They are then randomized to either the CAID or a standard control diet that also includes counseling from trained nutritionists.
Two innovators in the application of new technologies to healthcare delivery are contributing to the trial. AMC Health, a comprehensive provider of telehealth services, is an early leader in the implementation of remote measurement and monitoring methods in clinical research. AMC Health contributed to the design of the ulcerative colitis trial and will deploy its mobile technology to enable video study visits and vital sign collection in patients’ homes. MedPoint Digital has been developing a range of specialized digital platforms that provide channels for biomedical firms to engage with the medical community in support of clinical research. MedPoint is helping to manage patient recruitment, enrollment, electronic informed consent, and endoscopy video data storage for the trial.