U.K. approves informed consent technology
With a goal of pushing aside paper-based informed clinical trial consents and providing an electronic informed consent system, California-based Mytrus and an unnamed Top 10 pharmaceutical company are set to become the first organizations cleared to use eConsent technology in the U.K.
The U.K. Health Research Authority (HRA), a division of the National Health Service, has approved the use of Mytrus’ Enroll, a software platform and Web portal that uses a tablet device to give potential participants a trial overview. The technology includes explanatory videos to help people comprehend and retain key information before reading the informed consent form and answering questions to assess understanding of clinical trial risks, benefits and alternatives, along with what patients can expect in a trial.
Mytrus is the first company to provide the regulatory-approved informed eConsent clinical trial technology on both sides of the Atlantic. In 2011, it gained FDA approval to utilize its technology and software services, which have been used by large pharmaceutical companies in 30 clinical research studies. Since then, the company has received approvals from other national health authorities in Hungary and Brazil, along with 50 institutional review boards and ethics committees.
“We’re looking to expand to other European countries, as their ethics committees along with biopharmaceutical and device companies are looking to go through the regulatory process for eConsent,” said Anthony Costello, Mytrus’ founder and chief executive officer. “We had some sponsors who were interested in England specifically.”
Costello declined, however, to name the large pharmaceutical company that since July has become the first company cleared to use informed consent by the National Health Service. The eConsent pilot is being run in tandem with traditional paper consent forms so that the results can be compared, according to Mytrus.
In March, the FDA issued guidance explaining how biopharmaceutical and medical device companies should use electronic informed consent in clinical trials. The agency noted that it will permit companies to use electronic media and devices including graphics, audio and visual aids, interactive websites, card readers and even “biological recognition devices” to convey and capture information that facilitates the informed consent process. The distinction over the traditional paper document process prompted the FDA, in its new draft guidance, to state that “the term ‘informed consent’ is mistakenly viewed as synonymous with obtaining a handwritten signature … on a written consent form.”
Like the FDA’s decision, the U.K. approval of Mytrus’ electronic informed consent is part of an HRA program to promote and protect the interests of patients participating in clinical trials, as well as those overseeing ethics committees and innovation research. Additionally, clinical trial research staffers can track patient metrics to better understand where patients need counseling and dedicate time for each potential participant to discuss the study with site staff before agreeing to signed consent.
“With eConsent for clinical trials, the patient is at the center of the entire process to make more informed decisions armed with a better understanding of what’s expected,” said Costello.
An independent study of Mytrus’ Enroll software by the California Pacific Medical Center Research Institute found that patients provided with paper-only consents were able to correctly answer 58% of questions asked on a follow-up questionnaire. Patients using an electronic consent application fared better, correctly answering 75% of the questions.
The improved comprehension, along with other benefits for CROs, is why inVentiv Health uses the technology, according to Michael McKelvey, president of inVentiv Health’s clinical division and executive vice president of inVentiv Health.
“In just a short time, the Mytrus technology has proven to help U.S. sponsors address key challenges that have plagued the industry for decades,” McKelvey said in a prepared statement. “Applying this approach globally holds tremendous promise for improving the trial process for sponsors and patients around the world.”
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