Despite the promised decentralized trial revolution, we haven’t yet moved the needle in a significant way, although we are seeing far bolder commitments to this as we continue to experience the pandemic restrictions for some time to come. The vision of grandeur is one thing, but operationalizing and execution are another and recognizing that change, particularly mid-flight on studies, is worthy of thorough evaluation and consideration in order to achieve success. Here we will discuss one of the critical building blocks of a Decentralized and Remote Trial strategy, TeleConsent; more than paper under glass, it is a paradigm change and key digital enabler.
Informed consent is an essential process in clinical trial conduct that enables a qualified health professional to impart balanced information to potential participants about the benefits, risks and expectations of a clinical trial. eConsent, the electronic acquisition of a clinical trial participant’s signature that confirms the understanding and agreement to the information shared, offers a way to streamline that process and allows for better tracking, particularly if protocol changes should occur during the trial period. eConsent has the potential to reduce the bottlenecks, effort burden, and the expense of travel that in-person clinic visits place on future participants. Current restrictions issued by governing bodies in European nations restrict wholesale adoption of eConsent, but there is broad support to provide trial participants with more user-friendly and better information before, during and after consenting. TeleConsent takes the process a step further by allowing the participant and clinical study staff to be located in different geographies while participating in and obtaining informed consent. This method effectively removes the burden of manual paperwork and facilitates the further decentralization of clinical trials.
“The ideal clinical trial generates a minimal amount of credible, replicable, and evaluable data needed to answer meaningful questions with the least time and cost burden on participants,” said Donna Cryer, president and CEO of the Global Liver Institute. It is imperative that we can provide potential trial participants with clear information to outline the trial risks, benefits, schedule and data framework to enable them to make an informed choice about their healthcare decisions. As clinical trials have become more complex and more information is needed to be shared with participants, it is not unusual today for an Informed Consent Form (ICF) to be over 60 pages long, and this alone presents challenges for ensuring knowledge transfer and comprehension for participants. One of the further benefits of a digital consenting solution is the ability to present the approved trial information (ICF) in more digestible formats, with chapters, supporting information in hyperlinks, video files, animations and other media options that offer greater ability for a participant to review, digest, and comprehend the entire information shared. Having this information available to consider from the comfort of home, with time to discuss with family members/caregivers can significantly benefit a participant’s understanding and motivation. An important component of the traditional face-to-face consenting process is the ability of the participant to actively question and discuss the ICF information with a qualified professional, and it is vital that this opportunity is also available in a digital environment too. Enabling active discussion of the ICF via teleconference is a valuable and important step in ensuring a fully informed process is achieved.
As the informed consenting process increases in complexity for global, multi-site studies, requiring localization of language for patient facing materials and accommodating multiple version controls with local country and site approved document versions, the reliance on manual tracking becomes even more burdensome. The facilitation of centralized overview tracking through a digital platform offers immediate efficiencies and quality benefits, as well as providing options for automation of workflow management to improve compliance and visibility. Aspects like tracking, maintaining, and understanding where patients/sites are in the consenting/reconsenting process are challenging to monitor and can increase the risk of non-compliance if not accurately monitored. Ultimately, it can cause a significant delay in the trial and jeopardize regulatory compliance and data integrity; if a participant’s ICF is not captured in a compliant manner, the data may be removed from the study, which can result in an underpowered study.
As the industry progresses towards remote and hybrid trials, sponsors need to capture evidence and data of the patient performing fully informed consent outside of the traditional site environment, while standardizing processes to generate the evidence for submission. We have an opportunity to improve the participant experience of learning and understanding about the clinical trial and setting patients up for a high value, high satisfaction overall study experience.
The idea of conducting “site-less,” virtual, hybrid or decentralized clinical trials has been around for some time. TeleConsent can, and will, reduce barriers and enhance the clinical trial experience for patients and sites while improving participants’ convenience, resulting in increased patient motivation and engagement. Like any innovative approach, the rethinking of clinical trial execution has often been met with skepticism or reluctance; however, due to the recent COVID-19 pandemic, the pharmaceutical industry has begun to recognize and accelerate the various possibilities and benefits of a decentralized approach.
The primary intent of Informed eConsent is to protect the patient’s safety; therefore, safety, data quality, and the need for scientific rigor should be clearly articulated. In an article from Clinical Leader, experts at Otsuka Pharmaceuticals commented that “A better patient experience leads to a more informed subject and engaged subject – a more adherent subject that may help improve retention rates for patients to complete the study. This could lead to faster trial timelines.” The full article can be found here.
Complex language and lengthy explanatory information make it increasingly difficult for participants to understand what they are consenting to, reducing compliance, and increasing the likelihood of withdrawals. The development and adoption of new technologies make it possible to communicate, educate, and ensure that the participant has been provided sufficient and accurate study information. These new advances also allow for the acquisition of participants’ signatures electronically – a process referred to as eConsent. The use of eConsent currently has some restrictions in certain jurisdictions, such as Europe, specifically with the signature capture component. However, there is broad support for the use of an interactive, multimedia approach to providing patients with more appropriate study information.
The potential benefits of eConsent are numerous and will impact multiple stakeholders and sponsors. eConsent increases patient comprehension compared to a lengthy paper document and allows study participants the option to choose their preferred method (electronic or paper). Well-informed participants are more likely to make a knowledgeable decision about their voluntary participation in a clinical trial, allowing them to enter with realistic expectations and become more active partners in the study process. Study sites are able to reduce paperwork, lowering the burden on staff. Electronic management of updates to the informed consent document due to protocol changes also reduces staff burden and enables better document management and regulatory reporting. Even with these positive benefits, sponsors may have difficulty changing to a new process as current SOPs (standard operating procedures) and workflows are built for the paper and onsite process. Change management and stakeholder education with sponsors and the site will be important to gain traction and adoption.
As decentralized clinical trials have gained significant adoption in response to the global COVID-19 pandemic, there is a growing need for platforms that allow for TeleConsent to connect patients worldwide virtually with clinical sites. This allows clinical trial sponsors to screen, enroll, and consent participants in an environment where many patients are being told to shelter in place.
Traditionally, consent has been obtained using a paper process where the clinician and the patient are located in the same facility. Both parties sign the paper document to confirm it has been reviewed and understood. eConsent allows this process to be digitized and enables electronic signatures to be obtained at the site with both patient and clinician. This new process removes manual paper workflows and enables increased quality and compliance while checking real-time patient comprehension throughout the process. TeleConsent, on the other hand, means that a patient can be located geographically anywhere, distant from the site, and follow the eConsent process. Patients can be in their own homes and connect virtually to the site by TeleVisit. This process can also be used in a “re-consent” for any future changes in a clinical trial. Like eConsent, it is crucial with TeleConsent that the system is in line with the parameters outlined by the FDA in their December 2016 guidance and 21 CFR Part 11, and ICH GCP E6 R2. In terms of security and privacy, the eConsent system should be aligned to HIPAA and GDPR.
On Tuesday September 22nd, we announced general availability of Medable TeleConsent™, a new product that enables fully remote informed consent and re-consent for clinical trials. Unlike traditional eConsent products that require both patient and investigator to be physically present together in the clinic, Medable TeleConsent allows patients, doctors, nurses, and clinical trial staff all to connect and sign remotely from any location.
Medable TeleConsent solves one of the most complex aspects of clinical trials for patients, sites and sponsors and defines the first experience for patients of trial participation. By eliminating the need for multiple round-trip visits to clinical sites, TeleConsent dramatically improves patient accessibility to studies from their home location connecting them directly with their PI’s and site teams resulting in faster enrollment and greater participant diversity for trial sponsors—and better retention over the course of a study as patients have more options to enhance understanding of trial expectations. TeleConsent also improves patient knowledge and comprehension by providing medical information in visual and multimedia formats, which patients can review in depth together with family members and caregivers—and then engage visually with their physician to sign consent forms digitally from the comfort of their home or local clinic.
Medable TeleConsent is especially critical in the COVID-19 environment, where many patients are staying home to avoid social interaction and minimize exposure. Sites and sponsors can now screen, enroll and consent study participants without meeting in person, taking advantage of Medable’s TeleVisit application to conduct personalized interactions that improve patient understanding. Sites and sponsors benefit from streamlined workflows and enhanced data quality and compliance. Sponsors also get increased transparency with real-time reporting and insight into study progress. TeleConsent can also be used for re-consenting patients for any future changes that may happen in a clinical trial.
“Medable TeleConsent is a critical step in the evolution of decentralized research, as consent is the gateway to trial participation,” said Dr. Michelle Longmire, CEO and co-founder of Medable. “This has the potential to enable global patient access and improved knowledge, leading to greater participant diversity, retention, and ultimately research quality and speed. We’re excited to break down these barriers to benefit patients, sites and sponsors alike.”
To learn more about our TeleConsent visit us online or attend our webcast, “TeleConsent in Decentralized Clinical Trials Patient preference complemented by digital innovations-delivering on a long overdue promise.” on October 6th, 2020 register here.