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Mytrus announced the debut of its iPad application explaining informed consent prior to clinical trial patient enrollment. Using animation and other visual imagery, the Mytrus iPad application 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, digitized format. This new approach not only ensures better patient comprehension; it also helps researchers streamline the patient enrollment process for a more economical and quicker study start.
“The informed consent documents required at the initiation of a clinical trial are complicated; even with a clinician’s help, patients find it difficult to understand and retain the information,” explained Anthony Costello, Chief Operating Officer for 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.”
The Mytrus iPad application is now being rolled out globally for new and ongoing studies. Early adopters are noting that the application not only shortens the time required for patient enrollment; it ensures consistent patient education and comprehension of the informed consent process, an important consideration for multi-site and international studies.
Interim analysis data gleaned through a randomized trial conducted at Sutter Health’s California Pacific Medical Center Research Institute in San Francisco shows that patients using the Mytrus iPad application for informed consent have a significantly better understanding of clinical trial risks and processes. Twenty-four hours after completing the informed consent process, 76 percent of patients using the iPad application successfully passed a comprehension quiz; only 52 percent of patients using traditional paper-based forms demonstrated an understanding of the informed consent procedure. The difference between the groups is a statistically significant interim finding.
"The preliminary results from our randomized trial suggest that this new approach to the consent process may improve how well patients understand studies before they agree to join them," noted Michael C. Rowbotham, MD, Scientific Director for the California Pacific Medical Center Research Institute.
Using the Mytrus iPad application during the patient enrollment process is straightforward: Mytrus tailors the digitized informed consent documentation to fit the clinical trial protocol design and pre-loads the application to the required number of iPad devices. These devices are on loan to the study sites until the informed consent enrollment stage is complete. This easy deployment scenario ensures that any clinical trial, no matter how small, can improve the patient experience. Mytrus is also able to add the iPad consent process to ongoing studies still in the recruitment and enrollment stages.
A version of the Mytrus informed consent application based on the Android™ OS will be available in Q2 2012.