Electronic consent can personalize the patient experience in clinical trials and even improve retention. At Medable, where I am CSO, we’re committed to driving the adoption of this transformative technology.
Pictured: A physician speaks with a patient, surrounded by consent data/Nicole Bean for BioSpace
Patient consent for clinical trials is often considered a process to ensure a prospective participant can make an informed and voluntary decision to take part in research, ending with verbal or written consent. But it’s really an ongoing conversation. In fact, the FDA says the consent process should facilitate a thorough understanding of the information, allow enough time for thoughtful consideration and enable continuous trial updates so the participant remains informed for the duration of the trial.
Modern tools help achieve these broader intentions through the digitization of educational materials. At Medable, for example, where I am the chief scientific officer, we provide electronic consent (eConsent), which allows investigators to obtain patient consent through electronic systems, instead of traditional pen and paper. A 2023 study led by AstraZeneca reviewed the consenting process for 35 clinical trials (representing more than 13,200 participants) and found that compared with patients using paper-based consenting, those using eConsent had a better understanding of the clinical trial information.
While that may not be surprising in today’s digital world, other advantages of eConsent might be.
Electronic Consent Facilitates Human Experience
Can inert electronic tools, such as eConsents that rely on sterile computer screen interfaces also create a better human experience for prospective trial participants? According to new research, the answer is yes—if done right.
A new pilot study conducted by Medable and Duke University’s Department of Population Health Sciences’ Bioethics and Stakeholder (BASE) Lab compared an enhanced version of eConsent that incorporates various digital elements such as interactive videos, collapsible summaries and frequent knowledge checks or quizzes, against a text-only version. It looked at 24 patients—diverse in gender, age, race and geographic location—who reviewed an eConsent in a mock study for an investigative hypertension treatment. Half reviewed the text-only eConsent first, followed by the enhanced eConsent, and the other half did the opposite.
Study participants overwhelmingly preferred the enhanced eConsent, saying it made the process more engaging, informative and humanized. Yes, humanized.
"[The enhanced eConsent] 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.”
The results suggest the tremendous potential of novel eConsent solutions to revolutionize participant experiences in clinical trials by aiding in comprehension and satisfaction, especially during the daunting, administratively burdensome startup period. While the study sample size was small and results should be considered directional, the enhanced eConsent facilitated a better understanding of the trial information and made participants feel more engaged and prepared for clinical research than the standard paper version.
The personal touch was surprising—particularly as digital technology can be perceived as more cold or sterile. And, because the initial consent happens at the start of a trial, an enhanced eConsent tool may establish a more intimate connection to the trial for participants earlier in the process, laying the groundwork for a better experience for the duration of the trial and potentially improving retention.
Given these new, preliminary findings, eConsents are likely to become increasingly sophisticated, offering personalized, interactive experiences that enhance participant satisfaction, understanding and engagement.
In fact, as decentralized and digital approaches become more common in clinical trials, the use of eConsent may eclipse paper consent forms. In one large, bi-annual study by the Center for Information and Study on Clinical Research Participation in patient experiences with clinical research, use of eConsent forms (on an iPad, tablet or other device) increased from 24% in 2019 to 44% in 2021, dipping in 2023 to 32% likely due to the impact of the pandemic. Another report by Grand View Research projects that the global e-consent in healthcare market, which sat at just over $432.15 million in 2023, will grow at a compound annual growth rate (CAGR) of 11.3% between 2024 and 2030.
As eConsent could become standard practice in clinical trials, ongoing research, technological advancements and evolving regulatory frameworks will be essential.
While eConsents are uniquely important as a first touchpoint for patients with the trial and its investigators, there are many additional tools and steps the industry must take to ensure continuous patient engagement and comfort. For example, sponsors could provide investigators with telehealth tools to allow for more frequent face-to-face check-ins with participants that don’t add the burden of travel to the site.
Various innovative technologies and creative programs exist today to improve patient retention, but the industry needs to fully embrace the importance of creating systems that improve patient engagement from the start of the trial—i.e., consenting—to the end. It’s as much a mindset change as it is a change of processes or tools, and once the shift happens across all stakeholders, its practical application will follow organically.
Proving the Potential of eConsent
Evidence is vital for understanding the impact of new technologies on clinical research. In our study, we carefully analyzed behaviors such as the time participants spent on different sections and their engagement with interactive elements. This analytical approach provides critical insights that can guide the optimization of eConsent tools, ensuring they cater effectively to diverse participant needs.
But this pilot study is just the start. We must continue to gather systematic evidence for technology’s impact on trial execution. Because despite the clear benefits, technology adoption has been hindered by technological challenges, regulatory hurdles and inertia toward transitioning away from paper-based methods. Overcoming these barriers requires a concerted effort to gather data supporting technology’s efficacy alongside clear regulatory guidance and education to foster a culture of innovation within the industry.
Whether using AI, eConsent or other innovations, we first need to prove these technologies work so they are deployed responsibly to improve clinical research. It’s the fastest way to drive far-reaching transformation and widespread adoption of the tools that will yield the greatest impact on patients and trial outcomes.
Pamela Tenaerts, MD, is Medable’s chief scientific officer. She previously served as executive director of the Clinical Trials Transformation Initiative and has held various other research positions. She can be reached at pamela.tenaerts@medable.com.
