An iPad application that explains the informed-consent process to patients before they enrol in a clinical study has been launched by US-based clinical technology and services company Mytrus.
The application, which uses animation and other visual imagery to help patients through informed consent, is “the first in the industry to condense the complex and critical disclosure information required at the start of a clinical trial into an easy-to-understand, digitised format”, Mytrus says.
This not only ensures better patient comprehension, it also helps researchers to streamline enrolment for a quicker and more economical study start-up, the company adds.
Hard to understand
Even with a clinician’s help, patients find it hard to understand and retain informed-consent information, noted Anthony Costello, chief operating officer at Mytrus.
“Our iPad application simplifies the patient education process, giving sponsors better control of study starts and ensuring a better and more consistent continuum of care for enrolled subjects.”
Interim data from a randomised trial conducted at Sutter Health’s California Pacific Medical Center Research Institute in San Francisco show that patients using the Mytrus iPad application for informed consent had a significantly better understanding of clinical trial risks and processes, Mytrus reports.
Twenty-four hours after completing the informed-consent process, 76% of patients using the iPad application successfully passed a comprehension quiz, while only 52% of those using traditional paper-based forms showed an understanding of the informed consent procedure.
Tailored to protocol
In studies that employ the application, Mytrus tailors the digitised informed-consent documentation to fit the protocol design and pre-loads the application onto the required number of iPad devices. These devices are loaned to the study sites until the informed-consent enrollment stage is complete.
The Mytrus iPad application is now being rolled out globally for new and ongoing clinical studies. A version based on the Android operating system will be available during the second quarter of 2012.