Research participants want to feel like they’re more than just test subjects. Unfortunately, in the past, clinical research culture often left participants feeling research was performed on them rather than with them. Today’s researchers, therefore, need to gain trust, share information, and answer questions in order to recruit and retain trial participants. Fortunately, eConsent is offering new ways to do exactly that.
Remote eConsent goes far beyond ensuring the safety of both the participant and team members during a season of social distancing. It can also lower participant access barriers and democratize clinical research by recruiting, screening, and enrolling participants from the comfort of their homes. This can be a powerful enrollment booster; for example, 70 percent of potential research participants in the United States live more than two hours from the nearest study center. In this article, we’ll explore three ways remote eConsent can tangibly improve your next trial.
1. A seamless participant experience for onboarding leads to accelerated participant enrollment
Many trials face a similar challenge: enrolling sufficient participants. A lag in recruitment and enrollment can be both expensive and even can threaten a trial’s viability. The solution? A remote eConsent designed around the participant. It casts a wider net by enrolling, pre-screening, and consenting participants from any location using mobile apps on their own devices.
When it leverages multimedia components such as diagrams, images, videos, and screen readers, eConsent maximizes participant comprehension. It allows participants to review information at their preferred speed and even get feedback from family and friends. This translates into empowered participants who are joining a trial without feeling pressured or anxious—which can positively impact clinical trial retention later on.
Importantly, remote eConsent can easily be adapted to meet specific participant needs. Whether a participant has hearing or vision impairment, language or literacy barriers, or s other special needs, eConsent can easily address these. For example, forms can be translated into a participant’s preferred language, font size can be adjusted, and screen readers used to read text out loud.
Of note, an optimal enrollment experience does not ask a participant to switch between applications to complete video calls, signatures, and questionnaires. The more seamless the enrollment process, the greater participant compliance will be.
How Castor supports a seamless experience
- Participants can sign up through the participant enrollment portal. A pre-screening questionnaire helps filter appropriate participants.
- After consent, the participant is seamlessly added to the Clinical Data Management Platform and integrated into the study ecosystem.
- An easy-to-use and out-of-the-box participant enrollment portal can be customized to meet the needs of your trial.
- A customizable recruitment portal that automates participant recruitment. Branding, copy and pre-screening questionnaires can be added to the participant portal, improving participant workflow and enrollment rates while minimizing sponsors/CRO workload at sites.
2. Increased participant retention through better participant comprehension
Many clinical trials struggle with both enrollment and participant retention. Not only do 80% of trials struggle with enrollment, but some studies estimate that up to 30% of participants who join a clinical trial end up dropping out. Designing and running a study while keeping the participant’s perspective in mind can help at every stage of a clinical trial.
One reason participants drop out of trials is lack of comprehension. The goal of informed consent should not be merely getting a signature. Instead, it should focus on educating the participant on everything involved in the study, and explain the goal of the research. Keeping participants engaged and informed throughout the initial consent process can dramatically impact their overall experience and willingness to continue.
Another source of hesitancy for some participants is the historical lack of diversity within trials. As more studies prioritize diversity amongst participants representative of the distribution of the target disease, researchers need to build trust. An effective way to increase participant trust, engagement, and comprehension is by allowing participants to consult with caregivers and healthcare providers during the trial onboarding process. eConsent can allow participants more flexibility by cutting out site visits where participants may feel pressured to make a decision on the spot.
Additionally, leveraging multimedia elements such as videos, audio recordings, and images to break down complex medical or legal information into understandable language greatly increases participant comprehension. Video conferencing can recreate the benefits of on-site visits by supporting direct online video chats between a participant and a site member. This kind of one-on-one interaction greatly increases participant confidence, which translates into retention.
How Castor supports participant comprehension
- Video and automated remote Consent visits ensure participant and care-giver comprehension of study requirements
- Maximize participant understanding of trial requirements and risk with diagrams, images, videos, and screen readers for accessibility throughout the participant onboarding process.
- Increase engagement and retention by ensuring critical information, prioritized tasks and study context is always available online.
- Downloadable ICFs ensure sites and subjects can retain copies for their records.
3. Real-time insights for reduced site burden
Proper eConsent forms allow study coordinators to see in real-time where participants are in the enrollment process. eConsent improves overall consent tracking management and greatly decreases the risk of an invalid consent scenario. It also allows study teams to easily notify participants via email or text with updated information—which then ties into the increased participant engagement discussed above.
eConsent also makes it easy for site staff to pinpoint what areas participants are struggling with and what needs to be discussed in more detail. This opens the way for meaningful conversation and guarantees that the participant fully understands what the study entails. If participants have questions, these can be quickly resolved through video chats to ensure that the process keeps moving forward. All of this lightens the administrative workload for sites and study teams while ensuring regulatory compliance.
How Castor supports real-time insights
- View in real-time study progress and the number of participants screened and enrolled to meet trial timelines and recruitment goals
- Simplify administrative burden and ensure compliance by monitoring participant consent status in real-time and assign updated ICF versions to ensure meeting protocol requirements.
- An eConsent dashboard for sites and participants that is optimized for transparency and clear communication.
Helping move research forward can be a meaningful experience for participants. But doing so requires an optimized user experience so they feel empowered and committed. At the same time, site teams need efficient workflows throughout consent and re-consent processes. Fortunately, the right eConsent solution can accelerate enrollment, increase retention, and reduce site burden. The future of clinical research is looking bright!
At Castor, we are thrilled to see eConsent studies gaining momentum and IRB reviewers’ eagerness to embrace this new age of progress. If you want help setting up a study that meets IRB requirements, reach out to our friendly team members. We’re not only knowledgeable about all things eConsent—we’re also thrilled to help sponsors and study designers.