Kicking off a Clinical Trial the Right Way - With Seamless Digital Consent

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Kicking off a Clinical Trial the Right Way - With Seamless Digital Consent

While clinical trials have historically required participants to travel to physical sites multiple times over the course of a study, a growing focus on patient-centricity and recent global health events have transformed clinical trial conduct, accelerating the adoption of flexible technology options to support clinical trial recruitment and enrollment.

Today’s clinical trials have the ability to leverage telemedicine, electronic consent (eConsent), and other technology-mediated communications within a framework of decentralized clinical trial (DCT) to conduct personalized interactions that improve participants’ understanding and retention, while streamlining workflows, enhancing data quality and compliance, and increasing transparency with real-time reporting and insight.

Read on to learn more about how eConsent can enhance participant engagement and retention when used both onsite and remotely.

It all Begins with Informed Consent

Informed consent is the process for providing a potential participant with enough information about a study to allow for an informed decision about their participation. Collecting informed consent form (ICF) signatures has historically required participants to travel to a physical site, a burden that can create an insurmountable barrier for many potential participants.

In recognition of the desire to minimize this barrier, the FDA issued final guidance for the use of electronic informed consent (eConsent) in 2016, with similar guidance being issued by regulatory agencies around the world, including MHRA and EMA, among others. Today, with the latest technological innovations, eConsent has consistently demonstrated the ability to meet the needs of all stakeholders, including participants, sites, and sponsors, for both fully remote clinical trials, as well as hybrid clinical trials that include both onsite and virtual elements.

How does eConsent improve participant enrollment, recruitment, and retention?

In any clinical trial, a staggering number of participants—roughly 30%—are expected to drop out, making retention as important as recruitment.

Compared to traditional, paper-based informed consent, eConsent provides a significant advantage, as its participant-centric approach to informed consent can improve participant education, engagement, and comprehension, leading to improved retention throughout the study. Paper informed consent forms can often be confusing and overwhelming to participants, who are asked to read and comprehend a dense, lengthy document that looks like a legal contract. As a result, participants may not actually understand what will be required of them throughout the clinical trial, leading to high dropout rates later in the study. The use of eConsent, on the other hand, whether in-person or virtual:

  • Allows researchers the opportunity to present information in new and interesting ways through an interactive multimedia experience.
  • The web-enabled platform is Bring Your Own Device (BYOD) compatible, meaning it’s highly scalable on account of its ability to be easily accessed from participants’ tablets, laptops, or phones.
  • Enables all types of signature workflows to be built in, making it easy to capture signatures from participants, parents, caregivers, legally authorized representatives, and any other signatures that might be needed.

The use of eConsent and Teleconsent also allows researchers to recruit from a much wider pool of potential participants. As it minimizes the need for participants to travel onsite, it eliminates a major barrier to participation, allowing researchers to create a more inclusive clinical trial featuring a more diverse pool of participants, all of whom can provide their consent from any location, including their home. In addition, Teleconsent gives researchers the option to complete a consent document with a participant in real-time as part of a video call, allowing for personal attention for participants no matter where they’re located.

Digital Consent Eases the Re-consenting Pain Point

At any point in the study, re-consent may be needed if new information related to the study becomes available, the site or sponsor uncovers unknown risks or makes significant study alterations, or the initial consent process was deemed inadequate.

Re-consenting participants during a clinical trial has traditionally been a major challenge for sponsors and sites, often requiring another site visit, which increases participant burden. With the use of eConsent or Teleconsent, however, sponsors can now re-consent participants remotely using a solution that is automatically date- and time-stamped, reducing complexity and lowering the burden on participants. In addition, eConsent manages available templates, ensuring the correct version is always the one available and preventing the accidental use of outdated consent forms by site staff.

Learn More about Seamless Digital Consent

Medable’s 5-Step decentralized clinical trial workflow fully digitizes the screening and eConsent process, enabling greater participant access to the trial while providing a flexible and seamless experience across all users. Ultimately, this improves trial operations and time to treatment, while ensuring participants remain engaged in ongoing communication every step of the way.

To learn more about how this could benefit you, contact Medable for a demo today.