Minimizing Barriers to eConsent Adoption

For those suffering from rare and intractable diseases, clinical trials represent hope – for a more effective treatment, for a cure, or to help future patients facing similar challenges. Facilitating these lifechanging and lifesaving trials requires identifying, recruiting, and retaining participants who are informed and engaged, enabling greater participation, understanding, and adherence to a protocol.

At the core of this paradigm is the consent process: for trial teams, this first step in undertaking a study informs the rest of its management. Traditionally, patient consent for a trial has involved in-person consultation and paper-based processes that have become progressively more outdated in the face of increasingly complex trial protocols, digitalization, and the growing integration of connected devices as part of a study design.

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. Making the informed consent process truly patient-centric means taking full advantage of the capabilities of digital technology to improve the patient experience from the moment they begin the process through the moment they agree to participate in the clinical trial by signing the eConsent form.

Facilitating Simplified, Enhanced Informed Consent Through eConsent

Historically, the informed consent process for a clinical trial has involved dozens of pages of information for patients to review and ask questions about, followed by a handful of signatures and an unspoken understanding that those participating in a study understand all relevant aspects of that participation. Many patients unfamiliar with medical jargon, research protocols, or legal requirements are likely to give consent regardless of their ultimate understanding of what has been presented to them. This can impact later trial stages, as patients encounter unfamiliar protocols and complexities for the first time.

In order to give trial participants the best information, data, and experience possible, trial teams must engineer a patient experience that is interactive, informative, and easy to use. While both paper consent and eConsent should be supported by knowledgeable study coordinators and medical providers, the latitude eConsent can provide in personalizing the consent process for different learning styles, technological competency, or accessibility makes it an important tool in educating patients in the clinical trial process. Because eConsent can also offer participants the space to review consent documents from the comfort of their home, it also creates an important opportunity for more deliberate and engaged review on the part of patients that can be crucial to cementing their understanding of a trial.

Overcoming Hurdles to eConsent Adoption

Integrating eConsent into a clinical trial requires coordinated buy-in from a trial site and team to be successful. 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. Safeguarding patient data, crafting streamlined documents compatible with a range of consumer devices, and ensuring that patient-provider-trial team communication is maintained during eConsent are all core to establishing a robust, secure process.

Conclusion

For clinical trial sponsors contemplating introducing eConsent, circumventing the biggest barrier to adoption means focusing on site rollout. 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.

For many trials, eConsent and other technologies like ePRO and eCOA exist separately, alongside additional applications for recruiting participants and performing trial tasks. By working to integrate these disparate programs and applications into interconnected platforms with a single access point for users, clinical trial sponsors can create a more positive experience for patients and a more simplified, functional tool for tracking patient participation.

As regulators have begun signaling a preference for digitalized data collection, the advantages of eConsent have made it an increasingly crucial consideration for trial sponsors. By partnering with organizations with the requisite expertise and experience, sponsors can realize transformative gains in participant diversity, recruitment, and retention. Likewise, further optimizing these technologies as trials continue to grow in complexity represents a vital consideration for sponsors hoping to realize compounding benefits and avoid the pitfalls of dated, difficult consent protocols.