Patients age 65+ cite efficiency and preference over traditional paper-based consenting

Medable Inc., the leading technology provider for modern clinical trials, achieved an impressive 75% adoption of its Total Consent solution deployed in elderly patient population in U.S. Renal Care’s (USRC) investigator-initiated trial. The Phase IV trial, funded by a top-10 global pharmaceutical company, had a narrow recruitment window to enroll patients suffering from Anemia in End Stage Kidney Disease (ESKD) across more than 40 dialysis centers, involving 476 site users.

With a patient demographic primarily composed of people aged 65+ and unfamiliar with electronic consent (eConsent), USRC needed an easy-to-use solution, flexible to be adapted to the unique needs of elderly participants. Medable delivered. In fact, participants reported they preferred Medable’s Total Consent experience over traditional paper-based consent.

“Medable Total Consent helped us to rapidly launch and successfully recruit for a large multisite clinical trial and thoroughly consent a traditionally technology-averse demographic,” said Geoffrey A. Block, MD, Associate Chief Medical Officer and SVP of Clinical Research and Medical Affairs at U.S. Renal Care. “The product was straightforward to use, and its training demo modules made it easy to implement. Innovative and flexible, Medable Total Consent helps our industry move beyond simply relying on traditional paper consents.”

Total Consent allows participants to consent onsite or remotely, with eSignature or wet ink signature, increasing patient satisfaction by providing optionality. It can be tailored for use across over 115 locales in compliance with local regulatory requirements. In fact, its flexibility enabled USRC to suddenly expand recruitment mid-trial to Spanish-speaking populations. In less than two weeks, Medable added language translations and custom Spanish materials.

Enhanced eConsent solutions, such as Total Consent, that incorporate various digital elements (i.e., interactive videos, collapsible summaries, and knowledge checks) are poised to become the gold standard. Medable and Duke BASE labs compared enhanced eConsent against text-only eConsent across 24 patients and found 71% of patients preferred the enhanced solution, saying it made the process more engaging, informative, and humanized. Another study of the consenting process of 35 clinical trials (representing 13,200+ participants) found patients using eConsent versus paper had a better understanding of the trial information.

“Digital technology can be perceived as less personal, so we were surprised to learn that the digital enhancements to eConsent had a personal impact on participants and may help improve the consenting process in trials,” said Amy Corneli, PhD, Director of the BASE Lab and an Associate Professor in Duke’s the Department of Population Health Sciences.

“People sometimes jump to the conclusion that the elderly population is intimidated by technology, but well-designed technology is proving to help this demographic, and many even prefer it over paper,” said Dr. Pamela Tenaerts, Chief Scientific Officer at Medable. “Total Consent improves the experience for all participants plus it’s easy for sites to deploy even in large, multidimensional trials like with USRC. It removes friction for both patient and site.

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 on average of $500K in Phase II and $1.5M in Phase III trials, respectively.

About Medable

Medable is on a mission to get effective therapies to people faster. Its digital clinical trials platform enhances speed, scale, and patient access in clinical research, accelerating medicines for thousands of conditions without treatment or cure. Named a Leader in the industry by Everest Group and awarded Best Digital Health Solution by the Galien Foundation, the Medable platform has been deployed in more than 300 trials in 60 countries and 120 languages, serving more than one million patients globally. Medable is a privately held, venture-backed company headquartered in Palo Alto, California, and ranked #398 on the Inc. 5000 in 2023.

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