Animating Informed Consent

It is imperative that subjects participating in a clinical trial understand exactly what they are engaging in. Thus, informed consent is a crucial aspect in any trial, and clinical research professionals would be remiss if they allowed trial subjects to agree to take part in a study that they did not fully understand.

Screen shot of 3D animation showing how the RNAi drug inside the cells produces the active molecule (siRNA) to destroy RNA molecules produced by the virus.

With this in mind, Horsham, PA-based Nucleonics began to think outside the box when deciding how to best inform subjects about the scientific rationale and technology used in the company's recent trail of its RNA interference (RNAi), NUC B1000, a treatment for chronic Hepatitis B.

The Phase I study dealt with an experimental gene silencing therapy and utilized a technology known as expressed interfering RNA, which is a method not easily understood by your average study participant.

Therefore, Nucleonics turned to Arkitek Studios, a company in Seattle, WA, that specializes in creating visual materials for science, technology, and education. The partnership gave way to the first ever use of 3D animation for informed consent in a Phase I trial.

"This is complex information, and it's always hard to winnow down what the key concepts are within living systems in order to really understand a particular concept," explained Beth Anderson, chief executive officer of Arkitek, to Applied Clinical Trials. "None of these processes are simple, so the art is to figure out what is really needed to tell the story in the most compelling, understandable way to that particular audience."

To accomplish this, Anderson worked with Dr. C. Satishchandran, Nucleonics' chief operating officer and executive vice president, to understand the experimental therapy's technology and drew up storyboards explaining the process. Arkitek then developed 3D models and scenes, as well as a voice over script to compliment the animations. The company combined the animation, voice over, stills, and text to establish the finished product, which can be viewed on the Nucleonics Web site www.nucleonicsinc.com/clinical/video/video.html.

In the end, the animation succeeded in illustrating how Nuceleonics' therapy targeted four different sequences of the Hepatitis B virus genome to significantly disable the manufacture of specific Hepatitis-related proteins.

"It explained to the patients in laymen-friendly terms what RNAi therapy is, and why it works," said Anderson. "Also, equally importantly, it explained what it was not."

Since subjects entering a trial expect clear, accurate information about the treatment they will receive, the use of animation to map out complicated processes is an invaluable approach to informed consent.

"It allows greater standardization of information to the patient," observed Anderson. "Informed consent is absolutely critical, and is, quite rightly, essential to running successful trials. Hardly anyone participating in clinical trials has the depth of knowledge necessary to understand molecular biology—it's too involved, and why would they? But given the fact that they are participating in these trials, they really need to understand what they are being given, and I think that animation is one of the best ways to do that."—Samantha Etkin