Applied Clinical Trials
Science 37 and AiCure, an artificial intelligence (AI) and advanced data analytics company, have announced a collaboration to support and deliver enhanced technology for virtual trials. As the first endeavor for the new partnership, the two companies will use a virtual or decentralized research model-in which patients participate from home-to evaluate an investigational treatment for major depressive disorder (MDD) in a clinical trial this summer.
The MDD trial will involve 150 adult participants in the United States. Science 37 will recruit, enroll, and support patients using its virtual model and in-house network of investigators and mobile nurses. In addition, Science 37 will deliver eConsent, eSource, ePRO and telemedicine capabilities through its comprehensive clinical trial platform, the industry's first and only platform purpose-built to support virtual trials. The virtual approach adds an additional layer of privacy for patients, who can remain at home for mental health care, and increased efficiency for researchers, since many common psychiatric assessments-including the Montgomery-Asberg Depression Rating Scale (MADRS) used in this study-can be performed virtually by Science 37 investigators via telemedicine.
AiCure will enhance the quality of data collected and aim to reduce both the time and cost of conducting the trial by providing real-time monitoring of patient dosing and novel insights into patient behavior. AiCure's proprietary platform will monitor remote dosing adherence and measure digital biomarkers-including facial and vocal expressivity-to evaluate depression in patients. The platform will also enable remote registration, training, and micro-reimbursements to patients for increased patient participation. In addition, there will be real-time access to patient-quality metrics, which allows for quick, data-driven modifications to study requirements and improves the predictability of study timelines.
"Collaborating with AiCure is a unique opportunity to bring deeper and more novel insights to clinical research without participants ever having to leave the comfort of home," said David Coman, CEO of Science 37. "Combining our comprehensive, integrated platform with AiCure's unique AI technology will enable sponsors to develop even more meaningful data for their research."
"Virtual clinical trials offer a huge opportunity for both patients and sponsors by reducing the burden of having participants have to travel on-site, while also reducing the costs and duration of studies," said Dr. Ed Ikeguchi, CEO of AiCure. "Having the right tools in place can ensure patients remain engaged for the duration of a trial and help sponsors get critical and accurate data throughout."
The virtual research model has become the standard of clinical research in the current climate given the massive worldwide quarantine measures currently in effect. Considering the interview-based diagnostic tools such as MADRS commonly used in psychiatry, this model is particularly appropriate for depression research. Science 37 has conducted more fully virtual, interventional clinical trials than any other organization.