eConsent plays a vital role in enhancing existing clinical trials, but implementation teams continue to be concerned about the intricacies of eConsent acceptance in the pharmaceutical and medical device industries. Read on to learn about the challenges, approaches, concerns, and mindset shifts that research teams must undertake when contemplating eConsent for their studies.
The question of eConsent is less "Why?" and more "Why not?" Reading into the current scenario, people are using eConsent in the same way as paper—in the clinic alongside a face-to-face conversation. When used as a method to offer information to potential participants before a clinic meeting or as a follow-up after the clinic, it may add value. Read on and we discuss how eConsent is a transformative digital-first approach to participant enrollment. But first, let’s start with a little context.
eSignature vs. eConsent vs. Digital Signature: Are they the same?
The first hurdle to eConsent adoption is overcoming regulatory ambiguity. Misconceptions concerning "eConsent is only the eSignature" remain widespread among sponsors and sites, particularly when it comes to signature use. eConsent allows participants to evaluate additional sources of information ahead of time. All of this capability is built into the eConsent ecosystem and can occur before a visit to the site. Educating study designers and IRBs to recognize that the informed consent process is its own ecosystem, not just the signature aspect, is a critical step toward separating the components of eConsent that go well beyond eSignature.
eConsent always requires an electronic signature. However, eSignature standards differ by nation, which affects eConsent adoption. In nations that do not allow eSignature, our study shows that participants may frequently sign a paper form while on the video conference and subsequently send it in. Although this technique requires paperwork, it has two major advantages: the eClinical platform maintains consent status, and participants may access trial material online at any time.
People's views of a signature and a digital signature differ even at the most fundamental level. Are they the same thing? And do they imply the same thing under FDA rules versus in Europe? Vendors should be accountable for communicating what it means, clarifying terminology, and making it easy for research teams to grasp.
Digital vs. analog systems: Can eConsent enhance data retrieval over traditional paper processes?
The transition from analog to digital technology in the consenting process is not only a trend, but a requirement. Consider the traditional paper-based consenting process: actual folders, heaps of paperwork, and the constant danger of misplacing an important document. This analog technique, while familiar, has complications. The paperwork expands in proportion to the number of participants, increasing the danger of data loss.
Building on the webinar's observations, there is an evident "wait and see" approach to using new technology. This reticence is frequently motivated by the difficulties of introducing features and the perceived complexity of digital systems.
But let's dispel a myth: digital technologies, particularly throughout the consenting process, are intended to safeguard data storage. With everything kept electronically, data accessibility is effortless. If the study team needs to access a specific patient's permission document, it is just a click away.
Sponsors are hesitant to design their way into obtaining clinical data because they are concerned that all of the paper will be digitized in some shape or form and kept somewhere untraceable. There is no way for a responder to break into a digital system and overcome whatever access they have.
Then, examine data that they are not authorized to have access to. So, I believe it is indisputably true that digital systems are safer and better at controlling access to information or providing access to the appropriate information than analog systems.
Shifting to a “digital first” mindset creates a larger move toward eConsent adoption among sponsors
The "digital first" strategy not only emphasizes the safety and security advantages of eConsent over paper, but it also allows research designers and IRBs to explore the increased potential of the whole eConsent ecosystem in the open. Seeing the eConsent capabilities enables healthcare staff and study designers to determine how to give additional information tailored to the individual requirements of participants.
Digital systems can improve the patient experience by enabling researchers to create tools that are more efficient, interactive, and customized. If the tools are utilized in the waiting room, they can provide research participants with ample flexibility and time to prepare for consultations with physicians, create questions, and make the most of their waiting time.
By adopting a digital-first attitude from the start, research teams may guarantee that eConsent is not an afterthought, but rather a fundamental component of the study design. This proactive strategy may spark talks, ensuring that sponsors are aligned and on board from the start.
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