A Better Approach To eConsent: Flexible Consent Through Enabling Technologies
By Mike Hughes, Chief Product Officer, and Ian Greenfield, Chief Strategy Officer, YPrime
By and large, the clinical trial space’s perceptions surrounding eConsent fall into one of two categories. The first is an oversimplification – the idea that eConsent boils down to “DocuSign for clinical trials.” The second is an overcomplication, with many involved in the space writing off eConsent adoption as too heavy a lift for a clinical research industry already understaffed and stretched thin.
In reality, the ideal approach is likely both more achievable than some believe and more comprehensive than others have conceptualized. Factors on both the technology and compliance sides, as well as variables surrounding patient accessibility and usability, all serve to influence the eConsent paradigm. While this results in a necessarily complex platform, the eClinical technology industry has benefitted by implementing many design techniques and user-centric approaches gleaned from consumer-oriented industries, streamlining the patient experience and creating new avenues for data collection.
Electronic consent, or eConsent, digitalizes the trial participant consent process through increasingly simplified, interactive, educational models designed to improve comprehension and boost engagement. By organizing information about a study into easily navigable, digestible components and supplementing that information with visual and audio elements, trial organizers can give participants greater insight into a study’s design and their part in it, improving retention and enhancing subsequent study activities. As the industry continues to iterate on new technologies and principles that facilitate easier, better eConsent, these approaches will continue to demonstrate compounding value for increasingly complex and high-stakes clinical trials.
Better Informed Consent Through Proven Consumer Technologies
Traditionally, patient consent for a trial has involved in-person consultation and paper-based processes. Yet this practice has become progressively more outdated in the face of increasingly complex trial protocols, digitalization, and the growing integration of connected devices as part of a study design. The proliferation of both patient-centric (decentralized) and hybrid trials has created a need for more individualized, simplified, accessible processes involving trial participants.
Historically, the clinical research industry has been reluctant to adopt electronic informed consent. This was largely a function of the disruption that would result – many clinical trial sponsors, already working with staff shortages and under significant pressure, could not justify a move that might require a fundamental transformation of their existing processes. COVID-19 proved to be an inflection point, however, pushing many across the industry to adopt more digitized, remote technologies.
While DocuSign has represented an important solution for many industries in overcoming some of the limitations of pen and paper, it is often a digitized reflection of the physical documents it has supplanted – long, dry, and loaded with both legal and medical jargon. For trials, eConsent represents an opportunity to reinvent the way information about the study’s design is presented to patients, creating an avenue for more interactive and streamlined documents that can help participants better understand a study and their role in it. Ideally, eConsent is simply another resource for trial teams, affording them the latitude to engage with patients utilizing the right level of technology for both that participant’s comfort level and the trial itself. This may be as simple as collecting an electronic signature, or as involved as a guided consent document that has
been crafted to enhance user experience.
Improved Consent for Improved Trial Outcomes
According to a 2020 report from McKinsey & Company, more than 50 percent of clinical trial investigators surveyed anticipated an increase in eConsent technology adoption. While there was a level of initial interest in adopting eConsent technologies at the start of the pandemic, as well as some early entrants among technology suppliers, the reality of eConsent is only now beginning to gain true momentum. As the need for these technologies continues to grow, so does the importance of establishing fundamental goals for an eConsent paradigm.
The goals for eConsent are, of course, aligned with those of the traditional consent process, with improvements made possible by their technology components. These can include improved patient satisfaction, reduced regulatory risk, increased patient comprehension, and accelerated startup times for both study and site. Improving patient comprehension is perhaps the most important of these considerations – while establishing an eConsent platform that can compete with an in-person consent process is a lofty goal, it is critical to fomenting an approach centered around continuous improvement and patient experience.
Technology suppliers must be able to take the paper experience and enhance it, often through videos, interactive text, built-in knowledge assessments, and the ability to flag sections for review with a provider. The days of battleship gray and clinical fields are gone – integrating a consumer-grade UX and making it flexible, intuitive, and appealing represents the future for eConsent and eClinical technologies. The necessary capabilities, including identification protocols and other security measures, have already been pioneered in other industries, and taking those innovations and applying them to the clinical research space will go a long way toward optimizing eConsent.
eConsent: a Flexible Approach
The term “eConsent” is almost a misnomer – in reality, eConsent encompasses more than just electronic consent. At its best, eConsent is flexible consent, affording sites and users the latitude to pursue consent on-site or at home, with a provider or on their own, or blend approaches. The philosophy around an eConsent paradigm should be to meet a patient or a site where they are at a given moment. This “user first” approach is the best means of building a product from a consumer perspective; this requires a close look at every stage of the consent process, from onboarding to signature, to ensure the best possible user experience.
Trial sponsors and teams expend a lot of time, money, and resources in recruiting potential study participants. Having a smooth and engaging onboarding experience is crucial to maintaining that momentum and improving retention. This means finding the process’ friction points and working to correct them, as well as prioritizing ease of use at every possible juncture. Furthermore, creating an eConsent process that affords users information as needed and works to frame each piece of information accordingly can help avoid a “firehose” of information that can leave users feeling overwhelmed.
For site users, the larger eClinical ecosystems in which they participate can be vast and complex, with a dozen or more applications multiplied over several different trials. Considering site burden when developing an eConsent technology platform is crucial – how many software platforms are they already dealing with? Will this integrate easily within their existing systems? Is the eConsent system useful for transitioning participants to the next phases of a trial? While it is integral to focus on the patient experience, it is equally important that developers not lose sight of trial team experience or an eConsent technology’s place within a greater digital ecosystem.
Conclusion
Ultimately, the purpose of eConsent is to minimize patient and site burden and reduce attrition. By working to simplify its integration and communicate its importance, sponsors can more easily integrate eConsent on the researcher and provider side, ensuring greater buy-in and more standardized application across a trial or trials. This, in turn, can facilitate a slew of related process improvements, including better version control, more consistent data integrity practices, less administrative burden, and more timely insights into the recruiting process. Engineering eConsent technologies to integrate seamlessly with a trial team’s protocol and approaches is crucial; equally critical is designing these technologies in ways that are intuitive for participants.
