Medidata adds eConsent to cloud platform via acquisition of Mytrus

Cloud technology specialist Medidata Solutions is acquiring Mytrus, together with an industry-first electronic informed consent service, expanding its omnipotent clinical cloud platform.

Mytrus’ electronic informed consent technology was the first one reviewed and supported by the U.S. FDA for use in a clinical trial in 2011, and later evolved into what’s now called the “enroll” system.

Unlike the traditional dozens-of-pages-long, paper-based informed consent for clinical trials, the system uses a mobile device to display multimedia and interactive content, including online definitions of scientific terms, to educate patients. The more engaging process could help potential participants better understand their rights and responsibilities, as well as the risks and benefits of trials they’re about to enter, thus removing a persistent patient recruitment hurdle.

Mytrus probably made its name in the industry by providing technology support to the REMOTE (Research on Electronic Monitoring of Overactive bladder Treatment Experience) trial conducted by Pfizer in 2011. The benefits of an interactive online consent system have been observed from that landmark event: the first U.S. FDA-approved clinical trial that entirely used web-based methods to enroll and monitor participants.

An independent study involving 55 patients carried out by the California Pacific Medical Center Research Institute showed that patients using the enroll system were able to correctly answer 75% of the questions in a subsequent questionnaire about the trial, compared with 58% in the paper consent arm. It is believed that patients who understand such information are more likely to remain in the study.

Because the interactive system also allows patients to mark sections they don't understand, it helps trial investigators initiate meaningful dialogue based on those questions and better communicate about concerns.

The entire enroll system has been built around the needs of patients, about the “right to simple and convenient access to study information,” said Mytrus CEO Anthony Costello in a statement.

That patient-centric notion is for sure in line with that of Medidata. “The informed consent process is … 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 the statement.

“eConsent is rapidly becoming a strategic capability within the clinical trial landscape,” said Marisa Co, VP of business insights and analytics at Bristol-Myers Squibb, in the release. “It makes trial participation easier and more intuitive for patients, and sets the foundation for more advanced analytics for sponsors.”

As there does exist (and persist) a growing demand for more streamlined enrollment processes, regulatory authorities and major IRBs have shown their support for eConsent. Besides the FDA, the enroll system has been reviewed by India's Central Drugs Standard Control Organization, the EMA, and the National Health Service in England. Moreover, over 75 institutional review boards and research ethics committees have approved the system.

The industry is also gradually converting to that approach. Over 450 trial sites in different part of the world have used it, and about 100 completed or in-progress studies have used or are using the platform, according to a media aide at Medidata.

The acquisition seems to be a natural fit for clinical trial cloud technology company Medidata. It will incorporate the enroll system into its Patient Cloud platform, which already has AppConnect, a mobile app integration service; SensorLink, a data ingestion platform for biosensors and wearables; and ePRO, which allows sponsors to collect patient-reported outcome data electronically from mobile devices. The two plan to complete the acquisition in April.

Editor's Note: The story has been updated with information on which regulatory agencies have reviewed the enroll system, plus the numbers of sites and studies involved.