With dropout rates soaring and recruitment rates declining, Sponsors and CROs can’t afford to take any chances regarding their consenting and onboarding processes.
A study conducted in 2018 showed that the general overall perception of clinical trials is that they are burdensome. The study surveyed over 12,000 individuals representing 68 countries and included over 2,000 clinical trial participants. They valued the research but had a limited understanding of the clinical research process and felt that participating in clinical trials was burdensome. ¹ In this article, I will discuss how eConsent can help combat the negative perceptions associated with clinical research.
The informed consent process can influence patient perception. Trial administrators provide participants in the clinical trial process with an overview of the trial in detail. They explain their expectations for involvement and outline the requirements for the completion of the study. The challenge lies in making sure the participants understand the content.
How is informed consent collected?
Traditionally, informed consent in clinical trials is through face-to-face interactions between the trial staff and the potential participants. However, this process can be time-consuming and not feasible in all situations, particularly in the current COVID-19 pandemic, where in-person interactions are limited.
Electronic consent, also known as e-consent, is a digital approach to obtaining informed consent. It allows trial participants to review and sign consent forms electronically using their computers, tablets, or smartphones. This process can be completed remotely without the need for in-person interactions. It is a helpful tool for conducting clinical trials during the pandemic and beyond. It’s also worth mentioning that allowing participants to consent remotely gives them more time to read and assess the materials, leading to increased understanding for patients and caregivers.
In 2019 CRISPR released findings of a study conducted focused on patient retention. They learned that while 75% of their survey participants had participated in a clinical trial in the past, the vast majority preferred electronic consent forms and detailed a greater understanding of the trial and participant expectations. ²
There are several benefits to using electronic informed consent in clinical trials.
First, it can save time and resources by eliminating in-person meetings and reducing the need for paper-based consent forms. This can be particularly useful for large-scale clinical trials, which may involve many participants over a wide geographic area. Remote-based consent provides patients time to digest the information presented and saves sponsors money associated with the paper collection of informed consent.
Second, electronic consent can improve the consent process by making it more interactive and engaging for participants. Some e-consent platforms, like Datacubed Health eConsent, provide multimedia content, such as videos, animations, and interactive quizzes, to help participants better understand the trial and the potential risks and benefits of participating. This can lead to a more informed and empowered participant population, ultimately leading to better trial outcomes.
Third, electronic consent can help to ensure the integrity of the consent process by providing a secure and auditable record of the consent process. This can be particularly important for ensuring that participants fully understand the trial, the potential risks, and benefits of participating and that their consent is valid and ethical.
In summary, once you proceed with eConsent, you can combat the perception of unnecessary burden to the participants. By doing this, researchers can significantly reduce patient dropout rates leading to more successful clinical trials and outcomes.
Take the first step toward better understanding and engagement with your participants by trying out eConsent on Datacubed Health’s platform! Request your personalized demo today and discover how our platform can help you streamline and improve your consent process. Don’t wait – get started now!