PALO ALTO, Calif.—In September, Medable Inc. announced general availability of Medable TeleConsent, a new product to enable fully remote informed consent and re-consent for clinical trials. Traditional eConsent products require both patient and investigator to be physically present together in the clinic, but Medable TeleConsent allows patients, doctors, nurses and clinical trial staff all to connect and sign remotely from any location. This new product solves one of the most complex aspects of clinical trials for sites and sponsors, transforming the initial experience for patients by eliminating the need for multiple round-trip visits to clinical sites, dramatically improving patient access to studies and connecting them directly with trial investigators and site teams from their home location.
Additionally, TeleConsent improves patient knowledge and comprehension by providing medical information in visual and multimedia formats, which allows patients to review the information with family members and caregivers. They can then engage visually with their physician to sign consent forms digitally from the comfort of their home or local clinic.
Medable TeleConsent is especially important in the COVID-19 environment, where many patients are staying home to avoid social interaction and minimize exposure. The product will allow sites and sponsors to screen, enroll and consent study participants without meeting in person. They will also be able to conduct personalized interactions that improve patient understanding, which offers streamlined workflows and enhanced data quality and compliance, as well as 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.”
Medable TeleConsent was designed with a patient-centric perspective, informed by Medable’s Patient Advisory Council, a nationwide network of advocates who advise Medable and customers on ways to improve patient access, experience and outcomes. The product is also designed to be flexible, so the features can adapt to local regulatory, site and patient-preferred workflows, enhancing the experience while ensuring clear and accurate dissemination of critical information. TeleConsent also records digital evidence of comprehension and knowledge transfer, while capturing investigator and patient agreements to proceed. Having access to digital records is valuable for all stakeholders and sets the foundation for ongoing digital engagement between sites and patients. Designed specifically to power several modalities of decentralized trials, TeleConsent is available immediately and is the first eConsent application that enables patients, sites and sponsors to all engage remotely via web or mobile device in multiple languages.
“As the mom of three sons with rare diseases, we have a lot of experience with travel burden,” commented Jennifer McNary, rare disease advocate and chair of Medable’s Patient Advisory Council. “I definitely support reducing the risk to families, especially those with compromised health during this time. Making consent remote also helps those who may not otherwise be able to participate in a trial.”
Dr. Remo Moomiaie-Qajar, president and CEO of Cytonus Therapeutics, agrees with this approach. “At Cytonus, our diverse portfolio includes a COVID-19 therapeutic. One major problem we have had is the constantly changing regulatory requirements in various regions and countries. This has added multiple layers of complexity when it comes to consenting and necessitates re-consenting patients. Given that most therapeutics to treat viruses like COVID-19 are time-sensitive for the health of the patient, without a solution like Medable TeleConsent we would have significant delays enrolling patients that are extremely costly. Medable TeleConsent eases the administrative burden of thousands of hours safely spent remotely consenting for both investigator and patient.”