Medable, a company specializing in digital solutions for decentralized clinical trials, has released TeleConsent, software that facilitates fully remote informed consent and re-consent. The technologies enables patients, caregivers and clinical trial staff to sign remotely from any location, with no need to be physically present in one location.
Outsourcing-Pharma (OSP) recently spoke with two Medable representatives—Alison Holland (AH), head of decentralized clinical trials; and Jena Daniels (JD), director of research and head of the Medable Patient Advisory Council—about the benefits that TeleConsent reportedly offers to patients and trial teams alike.
OSP What are some of the traditional challenges with consent in clinical trials?
AH: Clinical research today remains laden by complex protocols, additional processes, and increased administrative burden. Informed patient consent, which is the cornerstone of GCP compliant clinical development, has also become ever more onerous, with long, complicated forms that may be confusing to participant. As such, one of the most significant and pervasive challenges with consenting for clinical trials is comprehension to facilitate better informed patient decision-making and subsequent trial motivation and retention.
Similar to the way people skim past the fine print of documents that use complicated language, patients will sometimes consent to something that they don’t fully understand because the language and traditional consent process hinder the transfer of knowledge. Unfortunately, this has ripple effects. In fact, failure to properly obtain informed consent is one of the most commonly cited quality findings in clinical trials and compliance in this process can be improved with an eConsenting solution.
A second issue is the administrative burden that traditional consenting process places on both patients and the study sponsor and their sites. Paper consent forms can be 80+ pages for each patient and there are often three copies of the consent form being processed so managing such extraordinary amounts of paper that must be linked to each protocol version and amendment is a manual, time-consuming task.
Then there are the same issues with each re-consent. Every time there is a protocol amendment, which can happen once, or more a year, depending on the overall length of the study, patient participants must go through the same lengthy, paper-driven process.
The third challenge is global variability; country-to-country regulatory issues and cultural acceptance. For instance, not all countries accept electronic signatures. Paper-based consent processes, and even many e-consent solutions today are not flexible enough to accommodate different demands worldwide.
OSP: How do eConsent solutions seek to address/alleviate some of these problems?
AH: Today’s eConsent technologies help alleviate consent problems by reducing the paperwork and associated administrative burdens because many paper forms are replaced by digital documents. In addition, these solutions allow companies to provide patients with supplemental materials, such as videos, diagrams, FAQ logs, and other multimedia tools, to aid in comprehension and present information in context; this becomes especially important for pediatric studies where a video might present information in a way that children can better understand.
In a 2019 eConsent Industry Survey, nine in 10 CRO respondents and nearly three-fourth of sponsor respondents report one of their top business drivers for adopting eConsent solutions is their impact on patient comprehension and engagement.
Another improvement that eConsent technologies offer is a referable digital record so regulators, patients, sponsors, and sites can all see the consent form immediately and for easy future recall, whether they are at home, at site or in a remote location. Greater visibility enables sites to onboard patients more effectively and increases overall trial efficiency while informed patients remain more motivated to continue to study conclusion.
OSP: Can you share some of the ways in which TeleConsent builds upon your average eConsent solutions and further improves/streamlines the process?
AH: Unlike standard eConsent solutions, Medable TeleConsent seamlessly integrates with our Televisit application to replicate the same in-person interaction and ensure reliable knowledge transfer for better patient comprehension. Medable enables a face-to-face experience so the physician can verify the patient’s comprehension in real life yet the patient and physician/investigator can be conveniently located anywhere in the world during the process.
There’s an open dialog with the patient so the physician can answer questions in real time and provide supporting information such as videos or diagrams for better comprehension.
Second, Medable TeleConsent is built-in to our DCT platform so that the consenting process happens seamlessly in the same workflow. This dramatically improves efficiency and reduces both patient and site burden. It also allows for all forms to be recalled at any time which improves administrative and regulatory work for sites and improves the patient experience.
The product is also highly configurable to accommodate different local and country regulatory requirements and cultural differences.
Another really important advantage – and something that members of our Patient Advisory Council (PAC) noted, too – is that Medable TeleConsent is not only well designed for initial consent but also more efficiently enables re-consent processes through the life of the study so the patient doesn’t have to travel and can have the same informed understanding with each new protocol amendment. Digital, Medable TeleConsent can push re-consent forms any time needed for faster re-consent and fewer trial delays.
OSP: Can you provide a little more information about Medable’s Patient Advisory Council?
JD: Medable’s Patient Advisory Council (PAC) is an inclusive network of expert patient advocates, advisors, and caregivers with diverse backgrounds in patient engagement and a strong understanding of patient preferences. The patient-led council is dedicated to improving clinical trial access and efficiency by embedding patient voices and perspectives into every facet of clinical trials, with the goal of bringing innovative, life-improving therapies to more patients at a faster pace.
OSP: How did the PAC help inform development of TeleConsent?
JD: Medable’s PAC was instrumental in the development of our TeleConsent product, as we strive to incorporate the patient and caregiver perspectives for all of our solutions. The PAC members reviewed the workflows, the patient screens, and the configuration. Was the interface intuitive? Were next steps clear? They guided our design from a patient/user perspective.
Also, Medable PAC members noted the feasibility of re-consenting using TeleConsent, and praised its ability to streamline a notoriously onerous process. PAC member suggested adding simple ways for patients to highlight specific sections of the informed consent form and flag related questions for site staff. In addition, PAC members offered ideas on how to simplify content in emails generated by the TeleConsent application so that the first communication to the patient from the system has the voice of the patient.
