By Benjamin Ross

January 23, 2018 | “I’ve never spoken to anyone who doesn’t see the benefit of [eConsent] to the patient,” Scott Askin, Novartis’ Global Director in Digital Development, told Clinical Informatics News.

In February, Electronic Consent (eConsent) will be the topic of a panel discussion during the 2018 Summit for Clinical Ops Executives–SCOPE—in Orlando, Florida. The panel, titled “eConsent after the Pilot: Implementation Lessons Learned by Study Experts,” will feature Askin; Eric Delente, President, Patient Solutions at DrugDev; and Jennifer Lentz, Consultant and Global Informed Consent Business Lead in Global Clinical Operations at Eli Lilly and Company, as they discuss the benefits and potential role of eConsent in patient engagement.

The consent process is often a participant’s introduction to the clinical trial. “eConsent improves the consent process for the patient with interactive elements like combinations of video, animations, audio narration, and illustrated pop-up definitions,” Eric Delente told Clinical Informatics News in an email interview. “We need to make sure patients around the globe know and understand both the tremendous benefits and limitations of clinical trials. We want them to understand what they are getting into, manage their expectations, and make them as comfortable as possible with the process.”

But eConsent has much to offer sites and study coordinators as well. For starters, Askin would like to see the distinction made between the Electronic Informed Consent Form (eICF) and eConsent in general. An eICF is something as simple as a PDF rendition of a standard paper form, Askin said, while eConsent goes way beyond an electronic version of a paper form, allowing additional educational information like videos and diagrams.

Most vendors have a patient-facing device, which, for instance, can be an iPad that has a consent form displayed on screen, Askin said. There can also be a dashboard or a website where the investigators can log in and see the status of participants, when a participant consented, whether or not the participant has agreed to electronic signatures (e-signatures), as well as audit information like who consented the participant and if he or she went through a re-consent process.

Today, technology makes eConsent available to trial participants through accessible and familiar devices. “Obviously iPhones and iPads and the fact that more and more people are using these everyday promotes the use of [eConsent] technologies,” Askin said. “It’s something that’s only really started to increase over the past 4 [years].”

Despite that potential, there have been growing pains in implementing eConsent.

“Over 77% of sites in [DrugDev’s 2016 Investigator Survey] self-reported that no sponsor or CRO had ever asked them to enroll patients with eConsent,” Delente wrote in a commentary for Clinical Informatics News last November. “As the clinical technology ecosystem evolves to catch up with familiar consumer apps, missing out on the benefits of eConsent can be a significant detriment not only to patients, but also to the sponsor’s bottom line.”

“One of the things we’ve learned, not just with eConsent but all the systems, is that you have to give teams additional support,” Askin said. “What we’re seeing with sites—[especially] the early adopters [of eConsent], the ones that are starting to use the technology—is the impact that it has on their standard process,” Askin said. “I think when you’ve been running trials for 20 years that when someone gives you paper you instantly know what to do with it. Changing that standard process that’s engrained in everyone’s mind is a change management process.”

Delente agrees with Askin, adding that sponsors know they should be using eConsent technology—because it not only eliminates paper errors, but also outperforms paper in areas such as record keeping and regulatory compliance—they just need to act on it.

Askin hopes that vendors will work to properly educate sites, especially site coordinators, in order for use of these new tools to become second nature, but as a sponsor, Novartis is doing their part as well. In promoting and perfecting their eConsent services, Novartis rolled our changes gradually through pilot trials in order to establish a set of processes. The company also made efforts last year to run awareness campaigns for eConsent and its benefit for trial sites, not easy according to Askin.

“Just informing people of such a technology is quite an undertaking,” he said. “We’ve done a lot of high level education [for sites] rather than detailed training, focusing less on the tools and more about what eConsent is and how it can be applied to new studies.”

“Another thing we learned in the early days, specifically with eConsent, was that using [e-signatures] worldwide is not quite as straightforward as we initially thought.”

Regulations for eConsent and e-signatures change from country to country, making gathering and validating e-signatures difficult. “There’s no one standard that you can apply,” Askin said. “So you have to learn within countries what is acceptable, and what our plan is for handling that.”

But nevertheless, Delente is hopeful. In 2016, DrugDev acquired SecureConsent, which Delente co-founded in 2005 with Susan Brink, to develop electronic systems for informed consent for global studies through DrugDev Spark. Delente and Brink worked closely with patients, IRBs, CROs, sponsors, hospital systems, academic institutions, and regulatory authorities to deliver the best process possible.

Now, he predicts eConsent will become standard practice in the next 5 years thanks to an increased focus on the participant experience; an emerging set of best practices resulting from draft FDA guidance; and sponsors and CROs wanting to avoid the 10-15% of audit findings related to consent. Delente compares it to the rapid adoption of electronic data capture (EDC) over the past few years, which has now become commonplace.

Both Delente and Askin believe eConsent is poised to make great changes in the clinical trial industry, but as Delente wrote last November, “There can be no change without adoption.”