Seeking a more effective alternative to paper-based electronic consent, the Joint Clinical Trials Office of Weill Cornell Medical College and New York Presbyterian Hospital announced that they will be introducing electronic informed consent technology into the hospital’s oncology clinics.
The year-long pilot program, in collaboration with Mytrus—a clinical technology and services company—will involve several hundred oncology patients, and iPads and instructional videos guiding them through clinical trials education, study volunteer rights and responsibilities and the risk and benefits about the specific trial they are considering.
“Video consent offers a fairly innovative way to present information to potential subjects, where we can provide more detail in a uniform manner beyond written documents and verbal discussion,” said John P. Leonard, M.D., director of the Joint Clinical Trials Office and associate dean for clinical research at Weill Cornell. “eConsent also allows us to test their comprehension, making it a tool to conduct informed consent more effectively.”
“In the past two to three years, we are seeing early adoption of eConsent in the form of pilot programs among sponsors and growing interest among academic medical centers and hospitals,” said Anthony Costello, Mytrus CEO and co-founder. “Our agreement with Weill Cornell and New York Presbyterian is the largest that we have established among major medical centers.”
Leonard said that Weill Cornel’s initial focus on oncology trials for eConsent is part of a growing effort to support precision medicine where there is increasing effort to collect patient tissue samples and to develop an extensive database of information. IRB approval is involved and Leonard said the hospital’s IRB is “enthusiastic” about using eConsent to improve patient understanding.
eConsent is supported by the FDA as an emerging technology that has the potential to enhance patient experience through interactivity, improved comprehension and convenience.
Under the Mytrus eConsent service, patients can highlight words requiring further explanation on an iPad and can prompt study staff to spend more time reviewing specific sections. If the volunteer answers a question incorrectly or only partially, the system automatically goes back to repeat a section of the video to make sure the information is seen again for the correct answer. Trial participants can also review trial information at home with family and friends on personal computers.
“My sense is that eConsent will provide more effective communications to subjects and a greater level of comprehension—even for those not getting all they need to understand or not paying attention, but getting the prompts to help them get the information they need,” said Leonard.
For Mytrus, the Weill Cornell pilot program, which starts next month, follows that of a large regional hospital, Grady Memorial Research Center in Atlanta. Grady Memorial plans to launch its eConsent program on June 22 after several months of technology planning and construction of privacy rooms where patients can sit and use the system.
“We want to demonstrate that eConsent can increase patient enrollment, boost retention and the additional cost is worth the efficiencies,” said Barry Riesenberg, president of Academic Research Centers and Hospitals (ARCH), a consulting firm that develops turnkey solutions for academic medical centers and hospitals including Grady Memorial.
“I’ve been looking for an eConsent solution for clinical trials for 20+ years, including walking the halls of DIA [Drug Information Association] conferences,” said Riesenberg. “I believe the technology has finally arrived.”
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