Patient response to new digital components in the electronic informed consent (eIC) process is overwhelmingly positive, with nearly three-fourths of respondents to a recent survey saying they find enhanced eIC more personable, engaging and informative.

The study, led by Medable, presented 24 hypertension patients with a text-only form and an enhanced eIC experience that used videos on placebos, randomization and electrocardiograms, four knowledge checks via drop-down Q&A panels, a patient journey map graphic and five collapsible study visit summaries for a faux phase 3 hypertension trial.

Although the enhanced version took considerably longer to get through compared to the text-only version, the majority of patients (17) felt it provided more information about the study and they preferred it overall to the text-only form. Participants noted the usefulness of the knowledge checks and learning things about the trial through different modalities, for example, and how the digital components compelled them to slow down while reviewing consent information.

The enhanced eIC was better, one 69-year-old female respondent said, “because it used more of a variety of methods to engage the reader and to explain the whole process. It was just more attractive and it was easier to read.”

“With the same ease we use our digital phones for shopping, entertainment and banking, we can educate about clinical trials. Graphic interfaces that incorporate videos, maps and images may be more effective in the consenting process to present the details of complex clinical trials,” Sandy Smith, WCG’s senior vice president of clinical solutions and strategic partnering, explains.

At the same time, some patients felt overloaded with information in the enhanced version and felt some of the components — the videos in particular — made the experience feel repetitive.

To Pamela Tenaerts, chief scientific officer of Medable, the time is now for making the informed consent process more innovative and demonstrating the value of doing so through evidence and data. She points to the length of the FDA’s August 2023 guidance on informed consent (CenterWatch Weekly, Aug. 21, 2023) as a clear signal that the agency wants to see more creative approaches.

As part of this, more studies need to be conducted to discern, at length, patient preferences for innovative informed consent components, as well as how different elements impact patient decision-making, including different populations and disease areas, she says.

“Too much of something good is not always a good thing,” Tenaerts told CenterWatch Weekly. “But only the participant can determine that perfect balance, and it can be different for different people,” she said. “We need to study this to better understand the effects and participant preferences of all these elements individually and combined on comprehension, satisfaction and decision to participate.”

“The use of digital consenting platforms,” Smith says, “will continue to increase and may contribute to breaking down the barriers to accessing clinical trials.”

Read the full study findings here.