Interactive videos, complete with soothing voices, explain hospital surgeries step-by-step, along with the risks and benefits, to enable patients to make informed decisions. Now, producers of these videos are adapting them for the clinical trials space, which for decades has relied on paper documents that often fail to adequately inform prospective volunteers.
A number of small companies that have developed interactive technology for hospitals and ophthalmology and cardiology physician practices are making the leap to clinical trials using an audio-visual format. The goals of both Emmi Solutions and Consent Technologies are to improve the retention rate of volunteers, who have said the current paper-based system is ineffective because it is filled with legalese and medical jargon and is part of a process that fails to explain the clinical trial.
“We found that most patients simply don’t know what a trial is about. Many fine doctors try to explain the drug trial, but those listening are not in a position to understand the information,” said Mark Mulert, senior vice president for Emmi Solutions, which has developed multimedia consent programs seen by more than one million hospital patients at over 100 hospitals. Emmi recently has expanded into the clinical trials market.
The focus, Mulert said, is to inform volunteers about the specifics of a trial through an interactive video with a separate paper consent form from the principal investigator—a combination that has enabled Emmi to receive approvals from Investigational Review Boards (IRBs).
Chicago-based Emmi, which employs medical illustrators, animators and writers, has developed interactive programs to support the consent process for pharmaceutical companies developing drugs to treat gout, liver and pancreatic cancers, depression and skin conditions.
Emmi’s strategy is to first ensure potential volunteers understand the clinical trials process, using a multimedia presentation with animation to explain it. The 15-minute video is shown before any discussion about the experimental treatment—a strategy to educate volunteers and more effectively retain them throughout the study.
With that baseline, Mulert said the doctor can then focus on the proposed drug treatment and address specific questions from study participants. Emmi provides volunteers with access to an interactive computer program that can be watched at home and shared with family and friends to help them better understand what they are consenting to. Each narrated video includes a complete description of the risks and benefits, as well as patients’ rights. It also tracks patients’ compliance as they view the information.
“We’re not intending to replace the physician conversation with patients, but enhance it,” said Mulert. “We have been very pleased that IRBs say this is the way information should be communicated. We also found that the additional cost to sponsors and CROs is minimal, and we don’t add complexity to the process.”
Consent Technologies also plans to use its online technology for clinical trial informed consent. It has developed a multimedia informed consent system for ophthalmology practices that enables patients to view videos with animations for 11 common ophthalmic procedures, including cataract surgery, LASIK and intravitreal injections.
As patients are shown the customized videos on specially-adapted interactive touch-screen monitors, they are prompted throughout the presentation to tap the screen and acknowledge if they understand what they have viewed or if they have questions. Upon completion, the Consent system captures the consent (or declination) in a written, on-screen signature and a recorded wave file.
For clinical trial consent, Consent co-founder and CEO Allen Stieglitz acknowledged the online signing is not yet approved by the FDA and that an almost paperless system will raise many questions.
Still, his approach with medical groups has won him endorsement from the American College of Cardiology, which praised Consent’s ability to marry detailed patient education with a fully defensible informed consent package—a combination he wants to bring to the clinical trials process.
“The bottom line is that interactive videos with a soothing voice that educate patients considering a clinical trial with all the risks and benefits explained can capture their understanding,” said Stieglitz. “And that is far better than having a CRO assign someone to read the consent form line by line.”