Minimizing Hurdles for Patients During the eConsent Process
Michael Hughes
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has involved in-person consultation and paper-based processes; however, this practice has become progressively more outdated in the face of increasingly complex trial protocols, digitalization, and the growing integration of connected devices as part of a study design.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.
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 participant 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. This approach has its pitfalls, of course – 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.
While structuring an eConsent document to conform with the different devices users may employ – from smartphones to tablets to laptops – can create some limitations with regard to content, these platforms typically allow for far more flexibility than paper consent. Trial design teams can streamline content, create visuals, and inject interactive elements to measure a patient’s understanding of the material, enabling a more engaging user experience that better serves the trial’s goals and leads to better patient retention.
Overcoming Hurdles to eConsent Adoption
Ultimately, the purpose of eConsent is to minimize patient and site burden, streamline enrollment, and reduce attrition. While many clinical trial organizations have begun to incorporate eConsent as part of their study designs, there exists a reluctance on the part of many sponsors to transition to more digitalized trial management. This aversion is common for technologies that represent a fundamental shift in how organizations in the pharmaceutical space operate. Yet the increasing pressures across industry to innovate and develop faster, coupled with the rise of patient-centric trial designs in the wake of the COVID-19 pandemic, have made concepts such as eConsent increasingly critical considerations for sponsors.
One of the primary limitations of traditional on-site clinical trials has been participant recruitment – an estimated 5 percent of eligible patients participate in clinical research. Accessibility issues impacting both patients and providers, coupled with a reluctance to revisit the protocols and controls that have been well-codified over decades of research, have served to slow the adoption of remote and virtual technologies for the clinical trial space. Geographic constraints, socioeconomic factors, and other variables have limited clinical trial participation in the past; the rise of remote trials has therefore created a potential avenue for more diverse patient pools, facilitating participation by reducing the logistical barriers inherent to brick-and-mortar trials. The eConsent process can turn this paradigm on its head, casting a wide net by allowing patients to register themselves online to be vetted for a trial.
Integrating eConsent into a clinical trial also 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. This approach creates distance and complexity for those engaging with it, particularly patients, who are typically unaccustomed to both clinical trial protocols and user experiences that are clunky or nonintuitive. 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 simplified, functional tool for tracking patient participation. Meeting patients where they are and affording them a streamlined, positive experience will be critical to advancing the concept of patient-centric trials. It will also serve to open certain trials to a more diverse patient population, and conversely, to give greater access to patients from underserved populations, including rural areas and minority communities.
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.
