Electronic informed consent (eConsent) platforms are among the most advantageous clinical technology products that sponsors and sites can add to their operations. These tools bring value for all stakeholders in the process.

• They simplify complex consent processes for participants, which leads to better engagement,
• They reduce the burden of paperwork for clinical staff, which leads to greater accuracy and efficiency, and
• They provide sponsors with real-time participant consent data to support the study management and regulatory processes.

So why have so many clinical trial sites delayed adoption of eConsent solutions?

The lag in adoption is not entirely unexpected. Healthcare professionals have a long history of using paper in their patient interactions. They are familiar with having patients fill out paper questionnaires, hand-writing prescriptions, and printing care information. They can instinctively be cautious about making changes to that routine.

However, the benefits of adopting eConsent in the trial environment far outweigh the temporary disruption it causes in clinical site routine.

A great first impression. eConsent sets the stage for a streamlined trial experience from day one. It creates uniform processes for developing and managing informed consent and sends a message to participants that their time and participation is valued. These participants are accustomed to digital interactions in their personal and professional lives. They will expect the same level of digital sophistication during the trial.

A feature-rich eConsent product also makes it easier and more convenient to complete consenting steps. Complex protocols can be easily explained using multimedia and electronic glossaries that are shared within the eConsent environment. These features create an engaging experience for all patient populations, including patients that are unable to read. Electronic forms with audio-visual effects can also be shared with participants so they can review and discuss the information with their families and caregivers in the comfort of their homes. This enhances participant understanding and frees site staff to spend their time with participants answering questions and addressing any residual doubts.

Focusing on patient wellbeing from the start helps build deeper trust which can translate into greater long-term retention. It is a gracious way to begin the trial and ensures participants have all the facts before signing up.

Compliance from day one. Research shows that incomplete informed consent forms is one of the most common reasons for protocol deviations in clinical studies. Along with cost implications, these deviations can render data unusable and create unnecessary delays in the trial. eConsent systems dramatically reduce this risk. In a review of nearly 100 trials across IQVIA that used eConsent, compared to paper, consent-related major and critical protocol deviations were reduced from an average of 14% to only 6%.

Digitizing this complex process removes the manual data entry and paper trails that often lead to error. Once participants complete the eConsent process, the information is instantly filed in the study database, creating a safe and permanent record of patient consents, which are easy for regulators to verify. The platform will automatically adapt formats and timing to follow local regulatory requirements, ensuring consent-related compliance across global studies.

Easy remote interactions. Decentralized and hybrid clinical trials give participants the flexibility to participate in clinical research without the need to visit sites for every step of the trial. eConsent tools support this flexibility by allowing site staff to consent participants efficiently, effectively and remotely. Consent forms may require signatures from multiple signatories, including parents, guardians, and/or Legally Authorized Representatives. eConsent allows each of these signatories to remotely read and sign the consent at their own convenience regardless of their location.

These flexible digital consenting options enhance the participant experience, which leads to better recruitment and retention rates at sites.

Seamless, intuitive site experience. Clinical site staff across the globe serve an ongoing stream of patients, often for multiple trials. Clinical trial activity further impacts their already busy schedules. eConsent systems ease efforts and simplify the complex process of tracking consents and protocol amendments by generating timely alerts and calls for actions.

So how can trial sponsors successfully promote the adoption of eConsent across sites?

If sponsors want sites to adopt this technology as part of their trial strategy, they must demonstrate the ease-of-use and time savings it will bring for site staff.

That begins with choosing an eConsent solution that is intuitive and easy to integrate into their trail workflow – site staff will abandon any technology that has a frustrating user experience for them or their patients.

When choosing a platform, sponsors should look for technology that offers features conducive to the trial protocol, provides a seamless user experience, and includes built-in tools that make it easy for patients to complete forms on time without added assistance.

When vetting eConsent options, it is important to also consider the support provided by the vendor. An experienced eConsent vendor with a global, dedicated implementation team will offer customization and training for the technology, as well as help desk support to sites and patients for quick problem resolution. That added help ensures a seamless roll out and adoption.

Once the eConsent system is deployed, sponsors need to reinforce the benefits during study initiation, kickoff and key opinion leader meetings. Offering recognition and encouragement for exceeding eConsent adoption goals can motivate sites and help them tide over initial hesitation towards new technologies.

The future will be digital

eConsent tools are poised to be a permanent part of the trial experience. Encouraging sites to adopt this technology today will enhance compliance and optimize consent data management while providing participants with a high-quality, engaging experience from the outset of the trial.

To learn more about IQVIA’s eConsent technology visit iqvia.com/eConsent