By Benjamin Ross

April 20, 2017 | 2017 Best Practices Awards | Medidata will acquire Mytrus, the two companies announced earlier this week. Medidata plans to integrate Enroll, Mytrus’ eConsent solution, into the Medidata Clinical Cloud as part of its ongoing commitment to modernize clinical trials for patients, sites, and sponsors. The acquisition is expected to close this month. No financial details were released.

Mytrus’ Enroll product helps educate patients about the clinical trial experience through the use of multimedia and interactive content to create a more efficient consent process. It informs site investigators’ understanding of patient questions, facilitating meaningful dialogue with the patient. And it helps sponsors increase patient retention and compliance, enabling better remote tracking of consent and improved document management and version control.

Medidata was impressed with the Enroll solution, as well as Mytrus’ other products and services.

“We’re excited about everything [Mytrus has] done, and we think there is a lot of potential, but we also wanted to emphasize a big area that our client base has been requesting from us for some time and that is eConsent,” Kara Dennis, managing director of mobile health for Medidata, said when speaking with Clinical Informatics News. “I think there’s a lot of momentum in that space.”

“The informed consent process is one of the most important parts of running both ethical and effective research projects. It's also the first step in giving patients a 21st Century experience, helping the critical elements of patient enrollment and retention in projects advancing healthcare," said Medidata’s president, Glen de Vries, in an announcement of the acquisiton. “Adding eConsent to the Medidata platform reinforces our commitment to improving patient engagement by delivering better tools, more data and higher quality insights for patients and researchers.”

Award Winner

The Mytrus platform also caught the attention of the judges for this year’s Clinical Informatics News Best Practices Awards, and earned them a Best Practices Award in Patient Data Management at the recent Summit for Clinical Ops Executives (SCOPE) in Miami, Florida.

The Duke Clinical Research Institute used Mytrus' Engage virtual trial platform to support the ADAPTABLE trial, Aspirin Dosing: A Patient-centric Trial Assessing Benefits and Long-Term Effectiveness, a federally-sponsored research study intended to compare the effectiveness of two different daily doses of aspirin. The platform helped DCRI rapidly engage patients remotely and provide an interactive platform to screen trial participants.

“The ADAPTABLE study and Engage, generally, we think is really exciting and potentially transformative in the industry,” said Dennis.

A great deal of clinical trial cost comes from opening study centers around to country to support large numbers of trial participants and their data, Anthony Costello, CEO and co-founder of Mytrus, told Clinical Informatics News. Originally, patients would jump through hoops in order to visit their doctors, have all of their data loaded on medical charts, and have that same data added to an EDC system throughout the duration of a trial. The result was a system that was neither cost-effective or time-saving.

DCRI wanted to see if it was possible to run a very large trial without opening any study centers. With Mytrus’ Engage platform, patients would provide their own data, such as self-reported medical histories, concomitant medications, electronic participant reported outcomes (ePRO), Quality of Life and health-based questionnaires, and patient surveys, remotely via web portals using a Bring Your Own Device (BYOD) model as the primary way that the patients engaged with the study.

Aspirin is widely used to prevent heart attacks and strokes in individuals with heart disease. The study wishes to assess the effects of low-dose and high-does aspirin, with half of the patients recruited being assigned the lose-dose of aspirin, and the other half the high. Depending on when they were recruited, a patient could spend anywhere from 2-3 years in the trial.

In order to recruit enough patients for an effective evaluation of the outcomes for this study, the DCRI team needed to rethink how traditional trials were conducted. The team had heard of Mytrus and the work they were able to do on a much smaller scale in other clinical trials.

“What we’re doing for the study is providing all the technology that underpins [the data management process],” said Costello. “Beginning with the patient coming in to our system and creating an account, then going through a consent process where they consent to have their data captured or stored, and then randomizing the patient to either low-dose or high-dose aspirin, and then following the patient for however many years they’re on the study and collecting their information regularly. All of those steps are done within Mytrus’ system.”

Currently, thousands of patients have been screened through the system from all over the country; Costello says this is the largest virtual trial ever attempted. The use of the Engage platform allows the sheer volume of potential patients that can be reached to increase.

“Our whole mission as a company is to build technology that gives patients better access to clinical trials, and helps them provide their own data,” said Costello.