Davis, CA. - March 07, 2016 - Mytrus, a pioneer in innovative technologies for improving patients' participation in clinical trials, has announced that its Enroll® and Engage™ technology infrastructure will support the ADAPTABLE (Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-term Effectiveness) trial being conducted by the Duke Clinical Research Institute (DCRI) as the study's academic coordinating center.
ADAPTABLE will enroll 20,000 patients—drawn from multiple large healthcare systems - and is designed to compare the effects of two different daily doses of aspirin for patients diagnosed with established atherosclerotic cardiovascular disease. The enrollment process will be supported by Enroll®, Mytrus' application for educating potential clinical trial participants and remotely gaining their electronic consent for trial participation. Then, Mytrus' Engage™ virtual trial platform will be used to randomize patients through an interactive web portal, follow them throughout the 30-month study, and provide a platform for investigators and clinical staff to interact with patients and collect patient-reported outcomes using web-based technologies.
"Over the past few years, the life sciences industry and regulators alike have come to recognize that patient- centered technology can — and should — be used to identify eligible patients, improve their understanding of study participation, and to keep them engaged in the process", notes Anthony Costello, Mytrus' CEO and Co-Founder, "Our technology will demonstrate how effective online tools can be in making certain trials more efficient and cost effective."
Matthew Roe, MD, MHS, of DCRI and a co-principal investigator for the trial, says, "ADAPTABLE has the potential to transform how we leverage electronic health records to identify potentially eligible patients for a clinical trial, use web-based technologies to facilitate patient enrollment and randomization, and engage patients from protocol design through analysis in a clinical trial. We're pleased to partner with Mytrus to provide the technology platform that will be utilized to conduct this novel trial that will investigate the efficacy and safety of low- vs. high-dose aspirin, both of which are used in current clinical practice in the United States."
Hospitals and clinics that are part of large, integrated research networks participating in the initiative will invite potentially eligible patients to participate in the ADAPTABLE trial. Potentially eligible patients will be directed to a web portal accessible through a standard web browser on a computer, tablet, or smart phone. Patients will be introduced to the study through multi-media tools that offer clear and memorable explanations (in English or Spanish). During the term of the study, participants will receive text messages and email reminders on a scheduled basis to log in and enter specific health information and patient-reported outcomes via Engage™, the virtual study data system from Mytrus.
"The beauty of this approach is that patients can enroll and participate in the study without having to directly interact with clinical investigators via an in-person clinic visit," adds Costello. "This trial is ideal for a virtual model because the trial design is pragmatic, and the product being tested (aspirin) is available as a widely available over-the-counter therapy."
Founded in 2009, Mytrus is a privately held e-clinical technology company specializing in patient-centered electronic informed consent and data collection tools. After receiving the first FDA approvals for remote electronic consent and virtual data collection, Mytrus has gone on to develop new technologies for patients including ePRO and EDC tools usable from home and mobile devices, bio-sample consent tracking technology, site training and e-learning applications, and patient home dashboards for tracking clinical study progress and data. Mytrus also holds an exclusive patent for conducting virtual clinical trials in the US. Mytrus investors include BioClinica and inVentiv Health.