The eCOA solution provider said that the platform is “an industry-first” in which eConsent and eCOA are incorporated in one platform.
The platform incorporates recommendations from the US FDA’s Guidance on informed consent in order to achieve better participant understanding of complex information.
“Awareness of issues associated with informed consent has been growing,” Rachael Wyllie, CEO, CRF Health, told Outsourcing-Pharma.com. “Currently, there is increasing complexity in clinical trial language and extensive paper-forms leading to a lack of patient comprehension, reduced protocol compliance, and increased drop-out rates.”
The program uses tiered information delivery to allow participants to learn about the trial by presenting content concisely and in a way which Wyllie said is more effective than reviewing a lengthy paper-document.
“Improved patient understanding is a driver in reducing risk in studies,” she added. “Patients who are better informed are less likely to drop out once enrolled because they've been better prepared to make their decision to participate.”
For example, the program uses interactive assessment check points at regular intervals throughout the consent process in order to allow patients to gauge their own understanding, in addition to allowing site staff to assess the participant's understanding of material.
“Participants can digitally earmark content they do not understand or want additional explanation of,” said Wyllie. Multimedia video, audio, narration, and images are also incorporated.
“By approaching simplified explanations from different angles using mixed media, the technology ensures patients truly understand the protocol complexities of a particular trial in the process of agreeing to participate,” added Wyllie.
While the new program is geared at benefiting the patient, Wyllie explained that improved patient understanding helps reduce risk in clinical trials.
“TrialConsent uses time-stamps to provide a clear, digital audit trail and makes the data defensible to regulatory authorities,” she explained. “Additionally, version control and electronic processes for content edits, approvals, and deployment means patients are not able to consent to an outdated or un-approved consent document.”
The program also enables study teams and ethics committees to monitor site and patient consent statistics and compliance.