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Palo Alto headquartered Medable Inc, one of the leading technology providers for modern clinical trials, has announced results from a new research project with Duke University Department of Population Health Sciences’ Bioethics and Stakeholder (BASE) Lab on the acceptability of enhanced electronic informed consent (eIC) in clinical trials. The pilot study compared participant comprehension and usability, satisfaction, and preference of enhanced eIC versus text-only eIC, specifically exploring the use of interactive videos, graphics, calendars, and other tools to augment text in an eIC form.
The study looked at 24 patients who reviewed an eIC in a mock study for an investigative medicine to treat hypertension: half reviewed the text-only eIC first followed by the enhanced eIC, and the other half did the opposite. The study population was diverse in gender, age, race, and geographic location. Nearly three-fourths (71%) of the study participants said the enhanced eIC was more informative and indicated that the digital elements were personable and made them feel more informed, engaged, comfortable, and prepared to participate in clinical research.
“[The enhanced eIC] is more appealing to me as a human being, not just a study subject,” said a 63-year-old male participant. “It made me feel more comfortable and showed that people were really thinking about what needed to be done to make this more understandable to a layperson. Taking the time to put those extra digital explainers in the consent form gave me a personal feeling attached whereas the other format was dry and cold…just a piece of paper.”
As decentralized approaches and technology become more common in clinical trials, the use of eIC may surpass the use of paper consent forms. In a large, bi-annual survey on patient experiences with clinical research, use of electronic consent forms (on an iPad, tablet, or other device) increased from 24% in 2019 to 44% in 2021, dipping slightly in 2023 to 32%. Duke BASE lab’s and Medable’s findings suggest that enhancing the eIC process with digital elements, including videos, knowledge checks, and drop-down menus, may have beneficial outcomes among potential participants beyond comprehension and satisfaction.
“Digital technology can be perceived as less personal, so we were surprised to learn that the digital enhancements had a personal impact on participants and may help improve the consenting process in trials,” said Amy Corneli, Director of the BASE Lab and an Associate Professor in Duke’s the Department of Population Health Sciences. “Further, because the initial consent process happens at the start of a trial, an enhanced eIC may pave the way for a more personalized connection for participants much sooner in the trial process.”
Dr. Pamela Tenaerts, Chief Scientific Officer at Medable, added, “We will continue partnering with leading academia like Duke’s BASE Lab, Tufts CSDD, Harvard MRCT, and others to gather systematic evidence of technology’s impact on trial execution. Evidence of how new methodologies impact protocol performance and trial experience is how we will affect real change. Whether using AI, eIC, or other innovations, Medable is committed to leading responsible, evidence-driven clinical trial transformation.”
Medable, which ranked in the top 8% of software companies on the 2023 Inc. 5000, has deployed its software-as-a-service platform in more than 300 decentralized and hybrid clinical trials in 60 countries, serving more than one million patients and research participants globally. Customers have achieved impressive results – including 200 percent faster enrollment and 50 percent cost reductions. A Tufts Center for the Study of Drug Development study shows that, on average, decentralized trials can achieve net financial benefits from five to 13 times for Phase II and Phase III trials, equating to roughly $10 million ROI and $39 million ROI for an investment of on average of $500K in Phase 2 and $1.5 million in Phase 3.
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