Best practices in designing engaging and valuable eConsent for clinical trials

Unlike paper-based consent forms which are often lengthy and difficult for some patients to comprehend, electronic consent (eConsent) solutions provide a more engaging consenting experience for patients with diverse health literacy needs and help them understand complex clinical trial information. However, gathering eConsent successfully requires study sponsors to design engaging experiences that help potential clinical trial participants understand the outcomes of participating in the clinical trial and clarify any misconceptions before they make the consent decision.

Doing so can improve patient engagement and retention in clinical trials and boost the quality of data generated from these trials. However, without the right design expertise, gathering eConsent effectively will likely be challenging for eClinical tech providers or pharma companies—especially when targeting large, diverse patient populations.

Below, we explore best practices to help you more effectively design eConsent for your clinical trials.

What is eConsent and why does it matter?

eConsent refers to the use of electronic devices like computers, tablets, or phones to provide potential study subjects or their legally authorized representatives with the information they need to consent and participate in a given study.

Whereas digital technology offers creative and wider-reaching avenues to communicate information about a clinical trial to patients before they consent, it must be designed to meet the unique needs of diverse patient populations. This will make them more likely to enroll and actively participate in a trial that uses well-designed eConsent practices.

In the electronic clinical outcome assessment (eCOA) or electronic patient-reported outcome (ePRO) space, a robust, engaging eConsent process acts as the first point of contact for patients before enrolling in a study. Therefore, it should be designed with the patient in mind—here’s how:

1. Make information digestible for patients

Designing eConsent tools that educate potential clinical trial participants about the full scope of benefits, risks, and challenges of enrolling and participating in a study will likely improve their consent experience and increase their likelihood of consenting.

Most—if not all—patients find it challenging to decide whether to participate in a clinical trial. Often, these patients are thinking through multiple questions and considerations. For instance, patients may question whether receiving an intervention will:

• Provide significant benefits to alleviate their specific condition in the long term

• Cause them to experience certain side effects and whether these would be dire

• Impact their quality of life or disrupt their normal routines over extended periods

These decisions become even more difficult when eConsent information is presented in complex formats rather than in simpler, digestible chunks.

By designing eConsent processes with patients in mind, study sponsors also comply with the Food and Drug Administration (FDA)’s revised Common Rule requirements that mandate discussions between clinical trial participants and their healthcare providers or study sponsors to help the participants decide whether a given intervention is the best treatment option for their unique situation.

2. Use interactive, engaging visual and audio elements

By incorporating the right mix of visual and audio components into an eConsent platform, study sponsors can create an engaging avenue to consent potential study participants.

For instance, a combination of video, audio, text, knowledge checks, and other elements tailors the delivery of eConsent processes to the comprehension needs of diverse participant audiences and tends to their unique learning styles. Enhanced digitalization of eConsent processes can actually create a more personalized connection for potential study participants, improving enrollment rates and reducing overall study costs.

So, it comes down to finding the right balance between delivering pertinent information to enable the consent decision while keeping study participants engaged throughout what is typically a lengthy, boring process.

These elements are also helpful when simultaneously consenting diverse study participants.

For example, younger patients may engage more with interactive video explanations whereas older ones might prefer to read the information out loud or listen to audio recordings. Some patients may choose to navigate eConsent themselves whereas others might lean on family support when reviewing the information about a clinical trial.

Patients with low literacy levels may also benefit from listening to audio recordings or watching videos containing the information they need to decide whether to participate in a clinical trial.

3. Develop robust backend processes and infrastructure

Beyond building the user-facing front end of an eCOA or ePRO user interface to meet the eConsent needs of patients, the backend infrastructure must include streamlined processes for collecting consent data from study participants and transferring it to the right stakeholders for processing and decision-making.

Using an eConsent platform simplifies the tracking and management of complex consent documents, delivering them swiftly to the appropriate locations. Likewise, it’s crucial to track end-to-end compliance with eConsent regulations, ensuring sensitive patient data remains protected at all times.

However, visibility across the backend of the eCOA/ePRO solution will help stakeholders to easily track these eConsent forms throughout their lifecycle and make decisions much faster to mitigate delays in achieving first patient-in (FPI) milestones. Such visibility is even more critical when collecting consent forms from multiple sites, especially globally distributed ones.

That’s where you can lean on Studion’s expertise in developing eConsent solutions.

Studion: Your trusted eConsent partner

At Studion, we understand the importance of designing engaging digital experiences for clinical trials. Whether it’s the eConsent solutions patients initially interact with or the eCOA/ePRO platforms that collect study data throughout the trial, we can help you digitize your clinical trial end to end. Studion’s eConsent expertise can apply to any clinical trial and any platform—enabling better patient compliance, improving data completeness and accuracy, and speeding up your study timelines.