As the modernization of the informed consent process looks to keep patients better informed with electronic presentations of trial information, sponsors and CRO may also utilize the tech to track more data.
The process of patient consent typically involves teaching patients about study protocols, possible benefits and harms, and their rights. But subjects often consent to a trial without understanding the study or their own rights. And now companies are looking to alleviate those issues with new technology patients might be more comfortable with.
Lindsay McNair, MD, chief clinical research officer at WIRB-Copernicus Group, told Outsourcing-Pharma.com, “Because electronic consent platforms can incorporate so many techniques - describing the study in an animated video, including actual video clips of study-related procedures, providing definitions for unfamiliar words, and assessing comprehension of the information.
“I think potential subjects will have a much better understanding of the study information even before they have the conversation with the study team member to talk about their questions and whether participation in the study is right for them,” McNair added.
According to a preliminary study, it seems patients understand clinical trials better with more interactive help. A study published in PLOS One last March using technology from Mytrus concluded that “combining an introductory video, standard consent language, and an interactive quiz on a tablet-based system improves comprehension of research study procedures and risks.”
Of the 55 patients tested in the California Pacific Medical Center-funded study, iPad subjects had significantly higher test scores than standard paper consent subjects and those with iPads also spent significantly more time reviewing the consent materials.
“And, in some platforms (like Mytrus), [patients] can flag the issues or words that they have questions about to improve and focus that discussion with the study team member,” McNair added.
Mytrus CEO Anthony Costello told us that his company’s technology could be a game-changer in terms of fixing the long, complex process of informed consent, which can include 45 pages worth of forms and inevitably lead to patient drop outs.
But he also noted the slow uptake of any new technologies in clinical research because of the sensitivity of the work. San Francisco-based Mytrus is now offering its technology to a number of sponsors, and Costello said that among the companies Mytrus reached out to for adopting its new technology, “none said, ‘No thanks.’”
In addition to easing the burden on patients, electronic consent forms can also offer sponsors access to data that they otherwise would not be able to obtain.
“There are other operational benefits to using an eConsent system such as version control (having only the current, approved informed consent version on the mobile device, so subjects never accidentally asked to sign an out-of-date version) and being able to track screening rates across multiple study sites from a central location to manage study enrolment,” McNair said. “And the ability to describe studies by video rather than text may really be of use in specific populations such as those with low literacy rates, and pediatric studies in which you have to obtain assent from children.”
In March, CRO inVentiv Health invested in Mytrus ’ new technology platforms. Gregg Dearhammer, president of InVentiv Health Clinical Strategic Resourcing told us that the investment will not change the direction of Mytrus.