By Benjamin Ross

June 14, 2018 | The discussion surrounding eConsent and its replacement of paper-based solutions in clinical trials is one that’s been going on for quite some time. And yet Rauha Tulkki-Wilke, VP of Product and Service Management at CRF Health, thinks, despite the growth, we’re still 2-3 years away from true mainstream use in the clinical research industry.

“Change takes some time in the pharmaceutical industry,” Tulkki-Wilke tells Clinical Informatics News. “What we’re seeing in the marketplace is that many sponsors are piloting the use of eConsent, evaluating it, and then the use of eConsent will ramp up.”

It’ll take some time before this “ramp up” reaches its peak, Tulkki-Wilke says. One reason for the moderate rise in eConsent use has been because of the complexity of many eConsent solutions.

“[Current solutions] rely on a process where create paper versions of the consent forms, and then you migrate the content over to an eConsent tool,” says Tulkki-Wilke. “The process is already quite complicated, so when you add a traditional eConsent solution on top of it, it may not make it any easier at all.”

A consequence of this additional complexity is that clinical trial sponsors feel like eConsent solutions are not ready to scale, Tulkki-Wilke says. “That’s why [CRF Health] wanted to solve the study setup challenge of informed consent.”

CRF Health’s solution, an electronic platform called TrialConsent, designs, collects, and manages the informed consent process all within the platform itself.

CRF Health launched TrialConsent in 2016 along with a suite of solutions. The suite gives patients the ability to self-register for a study through an online portal, complete the consent process with TrialConsent, and then complete the study, combining eConsent and electronic clinical outcome assessment (eCOA) on a single device. According to Tulkki-Wilke, it was important for CRF Health to make sure their platform was able to combine both solutions at critical points for the patient.

“eCOA in its broadest terms is really a tool and a solution that patients receive for the duration of a clinical trial,” she says. “In addition to the standard way of tracking patient data with diaries and questionnaires, eCOA solutions are being used to support patients through the studies, whether it’s reminding them about study procedures or study medication and upcoming site visits.”

The solution’s approach to eConsent earned them a Clinical Informatics News Best Practices Award for Study Startup and Design at the 2018 Summit for Clinical Ops Executives, SCOPE, in Orlando, Fla.

Tulkki-Wilke says that CRF Health has really taken the time to specialize in patient interaction, considering the global patient population and developing solutions that are easy to use.

“One of the big things we have in the product is that it’s a workflow management solution,” she says. “We didn’t want to bring to the market just a solution that can be used by patients to receive information about a clinical trial. We also saw the potential in a platform that enables the creation of these information resources that are site specific and customized for every participating study.”

Simplicity is a big factor in TrialConsent’s appeal, and Tulkki-Wilke says that removing any additional burden on clinical trial participants is the ultimate goal.

“We really feel that this was our specialty and this is where we are strong,” she says. “We looked at the patients’ concerns, what are all the touch points patients have in a clinical trial from start to finish.” What CRF Health found was that informed consent was the most important point of patient engagement.

“[Informed consent is] important in so many ways,” says Tulkki-Wilke. “Obviously there’re the ethical aspects to it, but also the points of patient recruitment and retention, and patient wellbeing. We felt we were in a really good position to take on the challenge and rethink the informed consent process.”

According to Tulkki-Wilke, CRF Health wanted to make sure the solution was not only accessible to the patients participating in a clinical trial, but for the trial site staff as well, something the clinical trial industry has been working towards recently (See, Coming To The Tipping Point Of eConsent).

“It’s a good point to make that TrialConsent has been created in a way that it doesn’t feel like a technical user interface,” says Tulkki-Wilke. “For example, trial sponsors can take the [TrialConsent] platform in use and create their own consent forms so, essentially, they don’t need a vendor to program a solution for them. They can use TrialConsent themselves to create their own consent forms. It’s very much about the content and making the content work for the study and the patient population, rather than programming a solution.”