Since 2018, Medable has grown a network of patients, caregivers, and care partners whose job is to help improve the clinical trial experience for participants.
Known as the Patient Caregiver Network (PCN), they regularly update their best practices, including recently refreshing their technological best practices around deploying eConsent.
We’re sharing them below to help continually promote the participant's voice and to help foster more equitable, inclusive, and diverse clinical trials
Best practice: Use a 7th-grade reading level or lower in the text of your eConsent tool.
Why: Clinical trial nomenclature is complex, lengthy, and can be confusing for participants. Simpler language better enables participants of different backgrounds to better understand your clinical trial’s requirements. Additionally, simpler language is easier to translate to other languages or convert to audio.
Best practice: Highlight or bold any difficult words, and provide a simple definition that can be revealed by a tap or click.
Why: Clinical trials often employ complex, jargonous medical language or terms. Providing a plain-text definition helps ensure better education, promoting better participant retention.
Best practice: Include a voice-over option for those who are auditory learners.
Why: Some participants may find it easier to digest consent information in an audio format, than with reading. Additionally, an audio option enables participants to complete consent in a way that fits within their lives as they can consume the information during leisure, travel, workouts, etc.
Best practice: Use visuals and/or images to simplify complex topics or processes.
Why: Imagery is great for visual learners, or as a way to re-frame or simplify complex processes that are difficult to convey with words.
Ex: Framing the participant's journey through the trial as a map or road.
Best practice: Provide a progress bar easily visible at the top of the display with the number of pages completed, and the number remaining.
Why: Participants often want to know how they are progressing through the consent process, especially with lengthy forms. A 2021 analysis₁ of four separate COVID-19 trials’ informed consent forms showed that they took an average of 35 minutes to complete. Here, providing participants with a sense of what’s completed and what’s left. A progress bar works best when paired with the next feature.
Best practice: Allow for stopping mid-way through the consent, with the ability to complete the remainder at a later time.
Why: Participants who are consenting remotely using eConsent often want to consume information in a way that fits into their lives. Enabling participants to stop and go enables them to complete consent at their own pace, chunking information into more digestible bites.
Best practice: Enable remote consent so that participants can consume information in advance, via web, tablet, mobile, etc.
Why: Participants often have better consent conversations with site staff and principal investigators when they can consume information in advance.
Best practice: Allow for easy connectivity to the trial’s help desk, from within the eConsent offering.
Why: Participants who encounter technical issues or who have questions should be able to instantly connect to a help desk to have their issues resolved, ensuring the consent process continues.
Best practice: Confirm when the participant has completed the eConsent process, with an email or otherwise that thanks them for their time and ensures their questions and understanding around the trial are complete.
Why: Participants are more likely to engage with trial when they believe their time is being appropriately managed. Additionally, confirming participants do not have any further questions helps ensure they feel ready for the trial and remain enrolled.