Digital and decentralized trials specialist Medable has launched TeleCOA, a solution that combines electronic clinical outcome assessments (eCOAs) with telehealth visits on web and mobile devices. The technology is intended to enable study outcomes to be reliably captured from a patient participant’s home, in order to transition eCOAs from sites to remote settings.
The platform is designed to enable study-specific digital workflows for patients and sites to perform recruitment, screening, consent, and throughout study conduct. Instead of being tied to site visits like traditional eCOA solutions, Medable TeleCOA reportedly enables outcome assessments to be conducted remotely via web and mobile, with a unified digital experience across the entire study workflow, with features like fully remote, live interaction between patients and clinicians to remotely capture outcome assessments while simultaneously evaluating a patient and offering guidance.
Allison Holland, head of decentralized trials at Medable, told Outsourcing-Pharma that the COVID-19 pandemic has accelerated interest in and adoption of decentralized trial technology.
“When COVID-19 first hit, sponsors worked to ensure trial continuity while patients and healthcare professionals (HCPs) locked down. This led to sudden greater adoption of telemedicine, initially in the form of basic, consumer-oriented teleconferencing solutions such as Zoom, and then in the form of more purpose-built life sciences solutions,” she told us.
Additionally, Holland said, sites and sponsors are on the hunt for trial technology that offers flexibility.
“The trend is towards adopting fewer point solutions towards modular platforms that support more specialized needs. Medable’s TeleConsent and TeleCOA modules are a good example as they all work together with our TeleVisit solution,” she commented.
Further, as trial teams delve deeper into decentralized trials and see what’s possible, they’re looking to add flexibility and functionality.
“The more they leverage the tools, the more they want out of them because they are seeing the tremendous benefits to all stakeholders, especially patients,” she said.
The TeleCOA solution is part of Medable’s overall digital and decentralized trial platform, engineered to provide users with flexible, modular and compliant trial technologies. The tool integrates with the company’s TeleVisit and TeleConsent offerings, which reportedly have helped sites and sponsors continue their work during the pandemic.
Michelle Longmire, Medable CEO and cofounder, said, “Enabling remote outcome collection is key to expanding access to clinical research. We’re excited to break down yet another barrier, and streamline the path to greater participant diversity, access, and engagement.”
Medable TeleCOA was developed in collaboration with patients and sites, with contribution from itsPatient Advisory Council network of advocates and advisors.
“As a health policy wonk by training, a clinical researcher by choice, and optic atrophy patient advocate by necessity, I believe we can learn a great deal from the patient community and incorporate patient perspectives across the clinical trial landscape to accelerate trial timelines,” said Medable PAC member Richie Kahn. “By combining eCOA with TeleVisits on any web-enabled device, Medable has made it much easier to shift onsite visits to remote without sacrificing the most important interactions between patient and investigator.”
Medable TeleCOA was also designed to meet the needs of eCOA scientists and clinicians. TeleCOA enables clinicians to interact with participants and administer outcome assessments, which can be critical to the outcome assessment process.
Medable is collaborating with researchers and scientists who are eCOA copyright holders to validate remote utilization of instruments and assessments.
“Validation of remote eCOA science is important and Medable is actively partnering with copyright holders and researchers to ensure that remote assessments are feasible and do not jeopardize the quality of the assessment or instrument,” said Longmire.
