Connecting Patient Centricity and eConsent Together
How can we embrace industry changes to become more patient-centric? As we’ve seen a shift in remote modalities to accommodate COVID-19 restrictions, there’s an increased need for a heightened participant experience in trials overall. However, it’s important to understand remote and virtual are not inherently patient-centric. It takes intentional design, adoption, and implementation to ensure remote tools are used in the most patient-centric way possible.
However, adopting a patient-centric mindset in trials benefits more than just the patient. ACRP reported, “patient-centric trials took almost half the time to recruit participants, recruited double the numbers of patients, and the drug was 19% more likely to be launched.” With this in mind, how can sites begin to become more patient-centric?
Components of Patient Centricity
When striving to become more patient-centric, there are a few components sites can focus in on and refine to create a better patient experience.
Supporting the patient experience should be top of mind throughout study planning, designing, and execution of a study. Adopting a patient-centric mindset doesn’t just affect the beginning of a trial when you are recruiting potential participants. It’s imperative to keep the participants in mind as they move through the trial, helping them to stay engaged and more likely to stick through a trial in its entirety.
When designing a study with participants in mind, there are a few things to consider. It’s important, to the best of your ability, to fit the trial to the participant’s schedule and daily life. Bringing the trial to them via their home or on their own device are ways to incorporate the trial into where the participant is. When meeting with participants, only collect necessary endpoints – avoid anything extraneous in the interest of their time.
Keep communication between you and the participant direct, thoughtful, and easy to understand. Saying what you mean and meaning what you say opens up opportunities for a healthy dialogue between you and your participants, helping them stay engaged in a trial. Additionally, creating a positive trial experience through consistent communication goes a long way as well. Participants want to feel valued, and they want to know their time and efforts are contributing to something meaningful, whether that’s through science, therapies, advancing research, or something else. Through consistent communication, it will help them feel like their effort is worthwhile.
How eConsent Aligns with Patient Centricity
A way to become more patient-centric is to enable eConsent at your site. An electronic consenting tool, eConsent, enables research organizations to improve compliance, better educate patients and measure participant comprehension, increase communication options, and cater to a variety of learning styles. By adopting an eConsent technology, sites have the ability to enhance the participant experience and increase trial success.
Enhancing the Participant Experience
Utilizing an eConsent platform can improve ease of use and overall comprehension in a clinical trial. Participants can use the devices they are already familiar with and consistently have on them to review study materials and discuss questions with site staff without having to visit the research site. This also enables parts of the consent process they can do remotely, and gives them time to read the consent at their own pace and discuss with family members on if participation is right for them.
A major benefit to adopting eConsent is supplementing the text with multimedia elements, such as video or links, to appeal to those who may learn best visually. It’s also easy to test for comprehension in an eConsent platform, including quizzes throughout the ensure participants understand the material they are learning about. Providing a glossary for complex terms and their definitions also increases comprehension, helping participants further understand the trial in its entirety.
Increasing Trial Success
Informed consent is more than a simple box to check off on the enrollment checklist. It can have a considerable impact on the success and safety of your study. Ensuring true informed consent while managing materials, documentation, and updates of consent information is easier said than done. This is evidenced by top issues frequently found in Food and Drug Administration (FDA) audits:
- Incorrect consent version
- Not re-consented when required
- Consent not dated by subject
- Check boxes and initials on pages left blank
- Subject was not provided a copy of consent
- Original consent missing
- No HIPAA authorization
By leveraging an eConsent platform designed to streamline workflows for site staff and supports patients throughout the trial, your organization can reduce audit findings. Through eConsent, participants are presented with the most up-to-date version of an institutional review board (IRB)-approved informed consent form (ICF), and research staff are notified when re-consents are required. This significantly improves version control maintenance by centralizing and deploying the accurate ICF. The ICF is also time stamped as signatures are captured, signed documents are automatically emailed to participants, and stored electronically. If a participant requires multiple documents’ worth of signatures, all documents are presented to them.
Quality greatly improves as well – eConsent enables FDA-compliant processes and documentation, helps eliminate deviations and audit findings, and increases both efficiency and ICF data quality.