A groundbreaking proof-of-concept study conducted by Medable and the Duke BASE Lab unveiled electronic informed consent (eConsent) solutions in clinical trials by demonstrating participant preference for an innovative enhanced version brimming with interactive digital elements such as videos, collapsible summaries and interactive quizzes against a traditional text-only eConsent version. The study’s core findings revealed a strong belief among participants that the enhanced eConsent version informed them better, which was lauded for making the consent process more engaging, informative, and humanized. With most participants favoring the enhanced version, the study demonstrates the potential of novel eConsent solutions to revolutionize participant experiences in clinical trials. We had the opportunity to explore this study’s findings in more detail with Amy Corneli, Associate Professor at Duke University, and Pamela Tenaerts, Chief Scientific Officer at Medable.

Moe Alsumidaie: Could you provide a detailed overview of the study’s structure and principal goals?

Amy Corneli: The study was designed to evaluate two distinct versions of eConsent: an enhanced version incorporating digital elements like videos, collapsible summaries, interactive quizzes, and a standard text-only version. Using a crossover design with randomization, we enabled participants to experience and compare both versions, thereby obtaining robust data. This methodological approach aimed to explore acceptability and comprehension.

Moe Alsumidaie: What specific findings regarding participant preferences and comprehension were observed in the study?

Amy Corneli: A pivotal finding was that 71% of participants indicated that the enhanced eConsent informed them better, noting its interactive elements made the consent process more engaging and comprehensible. Participants also said the enhanced version made them feel more comfortable with and prepared for clinical research.

Amy Corneli, Associate Professor at Duke University

Moe Alsumidaie: Based on your findings, what implications do you foresee for eConsent’s impact on clinical trial outcomes?

Amy Corneli: Our study suggests that eConsent, particularly when enriched with digital tools, has the potential to transform participant engagement in decentralized trials significantly. Enhanced engagement could potentially lead to higher compliance rates, lower dropout rates, and more favorable trial outcomes. Participants reported that the digital elements allowed them to be more engaged in the consent process, suggesting that future research should assess the relationship between enhanced eConsent and improved trial participation.

Moe Alsumidaie: How significant is the role of analytics in enhancing electronic consent solutions?

Pamela Tenaerts: Analytics are vital for understanding participant interactions with electronic consent solutions. Our study 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.

Pamela Tenaerts, Chief Scientific Officer at Medable

Moe Alsumidaie: What are the main barriers to the widespread adoption of eConsent, and how can these be overcome?

Pamela Tenaerts: Despite the clear benefits, adoption has been hindered by technological challenges, regulatory hurdles, and inertia toward transitioning from paper-based methods. Overcoming these barriers requires a concerted effort to gather evidence supporting electronic consent efficacy alongside clear regulatory guidance and education to foster a culture of innovation within the industry.

Moe Alsumidaie: How do you envision the evolution of eConsent within the clinical trial ecosystem?

Pamela Tenaerts: The future of eConsent is promising, potentially becoming a standard practice in clinical trials. Ongoing research, technological advancements, and evolving regulatory frameworks will be key to this transition. We anticipate that eConsent will become increasingly sophisticated, offering personalized, interactive experiences that enhance participant understanding and engagement.

Moe Alsumidaie
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Moe Alsumidaie is Chief Editor of The Clinical Trial Vanguard. Moe holds decades of experience in the clinical trials industry. Moe also serves as Head of Research at CliniBiz and Chief Data Scientist at Annex Clinical Corporation.