By Clinical Informatics News Staff

September 2, 2015 | Mytrus is conducting what it believes is the first electronic informed consent for a clinical trial in England. Its software platform for electronic informed consent has received approval from the Health Research Authority (HRA), a division of Britain’s National Health Service (NHS).

Although he wasn’t at liberty to disclose all of the details of the trial, Mytrus CEO Anthony Costello told Clinical Informatics News that the trial is a traditional clinical trial with a top pharma sponsor. “The study has been approved in England and is actively enrolling patients,” he said. “Lots of patients have already enrolled on the study using the technology since it was approved several weeks ago.”

In England, HRA was established to promote and protect the interests of patients participating in research and oversee research ethics committees, as well as innovation in research. HRA is interested in how e-Consent technology impacts both efficiency and the ethical treatment of patients.

Costello says the English trial is representative of the next step in Mytrus’ business evolution. “Now we’re going into a phase where we’re really trying to focus on internationalization, because most of our big 10 pharma clients are running lots of studies that include international recruitment.”

Mytrus was the first electronic informed consent technology approved for use in a clinical trial by the U.S. Food and Drug Administration in 2011. Last year, the company won a Clinical Informatics News Best Practices Award for its work with Pfizer on the REMOTE study. Electronic informed consent was one of two Mytrus products deployed on that study.

Costello believes that the US is reaching a tipping point for eConsent adoption. Earlier this year, FDA issued a draft guidance on eConsent; TransCelerate has announced an eConsent workstream; and the Clinical Trials Transformation Initiative hosted a session on eConsent as part of its Informed Consent project meeting in March. Other groups are also developing best practices and standards documents to govern the technology.

“It’s always interesting to be a first mover… because you have to sort of pave the way yourself for a while. There are other competitors with eConsent products now and they’re working hard to make this technology more adopted throughout the industry,” Costellow said. “But we are in a heavily-regulated industry, and it can be difficult to bring new technology to a market like this if you don’t have working groups or regulatory groups that are helping to define standards for the technology.”

As US adoption starts to pick up speed on the “hockey stick adoption curve,” as Costello sees it, other countries are getting on board as well. Mytrus has approval for eConsent from ethics and regulatory bodies in Brazil and Hungary. Conversations are ongoing in India and other countries in the EU.

“It’s been a process of moving around these various countries as the demand is there for a particular study,” he explained. “What happened in England was that we had a willing client, we had a willing regulatory group. We’d already met with [the regulatory body] a few times over the last year, so they were familiar with the technology and they saw that adoption was growing, at least in the US.”

In this case, the study is using Mytrus’ Enroll^® 2.0 iOS software platform and web portal, and began enrolling patients in July. The e-Consent pilot is being run in tandem with traditional paper consent so that results can be compared.

That’s not an uncommon plan, Costello said. “We’ve got some sponsors that have specifically decided to put half the sites on the electronic system and half the sites on paper because they want to do their own measuring of the differences or the cost efficiencies or the dropout rate on the study,” he said.