Mitigating the Application of eConsent

From its onset, the COVID-19 pandemic turned traditional methods of running clinical trials upside down. In particular, with trial sponsor employees and participants stuck at home, enrollments via paper-based processes turned untenable. Consequently, many sponsors transitioned to eConsent, designed to replace paper processing with digital tools. Although eConsent existed prior to the pandemic, the global health crisis forced sponsors to quickly adopt a digital approach, designed to simplify clinical trial consent via an invitation that prompts patients to log in and learn more.

An opportunity to develop a more flexible eConsent approach

In 2020, a team of researchers from Weill Cornell Medicine reacted to barriers faced by those who were adopting eConsent into academic settings.¹ YPrime, headquartered in Malvern, PA, responded to the demands of researchers and developed a unique eConsent platform (FIGURE 1), recently launched in November 2022.

FIGURE 1: YPrime’s eConsent platform and patient-centered approach ensures better comprehension of complex information, accelerates enrollment and screening, and improves patient engagement.

Empowering patients in the process

Although a company could simply digitize a paper approach to clinical trial consent, similar to converting a magazine article from a print edition to a digital PDF, making the most of eConsent requires more. YPrime developed its eConsent platform from a patient-centric perspective, ensuring the entire patient journey is taken into consideration.

Achieving such a patient-centric process relies on several crucial features, all encapsulated into YPrime’s eConsent platform. YPrime’s eConsent platform is simplified and self-paced, making it easy for a patient to login and review background information about a clinical trial at a time that works best for them. The platform can be accessed on various devices, including a mobile phone, tablet, laptop, or a desktop computer, and patients have the flexibility of swapping from one device to another during the process. To expand its reach, YPrime’s eConsent platform allows for multilingual interactions.

Strong but simple for sponsors

Beyond its benefits to patients, an effective eConsent platform must also accommodate sponsors and sites. Most importantly, the platform must be secure—keeping data safe for everyone involved in a clinical trial. YPrime encrypted its platform and designed it to incorporate features that make it compliant with audits, government regulations, including 21 CRF Part 11,² and industry standards, including NIST-800-53.³

YPrime’s eConsent platform also meets the more practical needs of clinical trial sponsors, as it is designed to fit existing workflows. A single login feature integrates the system with other applications, and trial sponsors always have access to real-time permissions data. In addition, the YPrime eConsent platform automatically prepares screenshots for institutional review boards.

A complete solution

Overall, YPrime’s eConsent platform ensures that patients better understand the increasingly complex information around clinical trials and remain engaged throughout a clinical study. It also helps sponsors enroll and screen patients more quickly and efficiently.

These features lie at the very heart of success in advancing healthcare. In 2021, Kenneth Getz, deputy director of the Tufts Center for the Study of Drug Development, and his colleagues noted, “As clinical trial protocol designs become more complex and eligible patient populations narrow, it is becoming increasingly difficult to recruit participants and retain them for the duration of the trial.”⁴ To accomplish so many crucial objectives, YPrime’s platform makes eConsent a part of the entire clinical trial process, rather than a single step. YPrime’s platform transforms eConsent into an advanced method that empowers patients to make more informed decisions about participation and eligibility into clinical studies.

References

1. C Chen, P Lee, K Pain, et al. Replacing paper informed consent with electronic informed consent for research in academic medical centers: a scoping review. AMIA Jt Summits Transl Sci Proc. 2020: 80–88 (2020).
2. US FDA. Guidance Document: Part 11, Electronic Records; Electronic Signatures - Scope and Application. Accessed November 2022. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/part-11-electronic-records-electronic-signatures-scope-and-application/
3. National Institute of Standards and Technology. SP 800-53 Rev. 5: Security and Privacy Controls for Information Systems and Organizations. Accessed November 2022. https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final/
4. S Sine, A de Bruin, and K Getz. Patient engagement initiatives in clinical trials: recent trends and implications. Therapeutic Innovation & Regulatory Science. 55: 1059–1065 (2021).