Simplified eConsent as a case study for improving trial operational efficiency
By: Andrés Escallón, Vice President, eClinical Innovation
Our lives have become more digital by the day. This is especially true in the healthcare space, where building out solutions to digitize old paper processes increases efficiency across the industry. Decentralization has become a hot topic in healthcare, yet despite being a buzzword in recent years, decentralization has been revolutionizing the clinical trial space since well before the pandemic. Solutions like site feasibility, patient payments, electronic clinical outcome assessments (eCOA), and electronic data capture (EDC) have all been developed to optimize the clinical trial continuum. However, there is still a technological gap in consent management for patients, sites, and sponsors.
Although eConsent solutions have the potential to dramatically improve the informed consent process, we must consider how to integrate these solutions with the existing tools for clinical trials. Such integrations can simplify workflow for patients, sites, and processes, rather than make them more complicated.
Complacency with burdensome paper processes
To understand the need for a patient-centric eConsent solution, we must first understand the paper process of informed consent — including the challenges and consequences that come with it.
Paper consent documents are often long and legalistic. This makes it difficult for patients to read the document and understand the terms of their participation in a trial. For sites, sponsors, and CROS, this manual process creates a cumbersome paper trail with no real-time information on consent status or enrollment by site. Further, separate consent forms for different countries and languages, version control, and protocol amendments all make paper consent inflexible, operationally challenging, and burdensome. These complexities bring with them the risk of not properly informing patients, errors at sites, or even compromising entire studies. So with all of these challenges and their associated risks, why do people continue to lean on paper consent processes? Trust.
Familiarity with paper consent often leads people to accept the consequences that come with it — just as sponsors don’t want to disrupt sites with new processes or upset site personnel who are accustomed to using paper, a patient’s trust in paper consent can create resistance when they are introduced to new technologies.
The appetite for a simplified informed consent process exists, and will inevitably increase as more people are exposed to eConsent as a solution, just as it has in banking and other highly-regulated industries. According to our recent survey on people’s awareness of eConsent and their preferences between paper and electronic consent, 50.2 percent of US respondents actually prefer to sign electronically (either at home or on-site).
Simplified, patient-centric solutions can address the problems in manual processes that many have grown accustomed to while also building trust that the solution works as it is designed to — without overwhelming the patient.
Meeting sites and patients where they are
Like other areas of technological innovation, clinical trial decentralization aims to address the burdens and errors associated with manual processes without introducing new complexities. To accomplish this, one must consider existing burdens on the coordinator, the investigator, and most importantly, the patient.
Simplified eConsent solutions are inherently patient-centric because they take into account the challenges of the end user while also making patients feel like humans rather than just another number. For example, a recent JAMA study found that improving the readability of informed consent documents — something that eConsent achieves — could increase patient accessibility. In addition to accounting for the challenges, simplified solutions give more time for investigators to focus on what matters — getting lifesaving treatments to patients faster.
Practical innovation prioritizes accessibility
Suvoda’s technology is meant to manage complexity, not make trials more complex for the sake of innovation. This is why our approach revolves around two core tenets: simplifying the innovation process and creating a unified, patient-centric ecosystem that seamlessly integrates within other eClinical tools.
When it comes to innovation, it’s what you take out that matters. Simplifying a technological solution demands a concerted effort to edit yourself so that you don’t overwhelm the user. Once we identified the challenges of paper consent, we used them as a guide for creating a unified ecosystem with our eConsent product — one that is elegant to manage, offers high visibility and control, and unparalleled speed and flexibility — all while leaning on the advantages of increased accessibility that other decentralization tools bring.
When eConsent and IRT are integrated, eConsent creates a virtual “gate” so that only patients who have signed the latest consent forms are dispensed the drug — simultaneously protecting patients while reducing friction for sites and sponsors. Rather than trying to solve the process of making the informed consent process better, we provided a patient-centric solution with administrative tools that generates momentum to drive adoption of eConsent on a broader scale.
Introducing new solutions to people doesn’t have to be an uphill battle when we refocus our innovation on simplicity and patient-centricity. At the end of the day, we are here for patients — only when we all work together to better guide and influence our innovation will we be able to take the steps toward a better way.
Vice President, eClinical Innovation