First Ever Use Of 3D Animation For Informed Patient Consent In A Phase 1 Trial

Main Category: Liver Disease / Hepatitis
Also Included In: Clinical Trials / Drug Trials
Article Date: 23 Jan 2008 - 3:00 PDT

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For the first time, a 3D animation has been used to inform patients about complex scientific information as part of the informed consent procedure for a Phase 1 clinical trial. Arkitek Studios, specialists in the development of visual content for science, technology and education, created the animation to help patients understand the scientific rationale behind the experimental gene silencing therapy for Hepatitis B being developed by Nucleonics, Inc.

Nucleonics announced on January 11, 2008 that the company had begun treating patients in a Phase 1 human safety study of its experimental RNA interference (RNAi), NUC B1000, a treatment for chronic Hepatitis B virus (HBV) infection. The experimental therapy uses a technology known as expressed interfering RNA to simultaneously target four different sequences of the HBV genome, resulting in a potent antiviral effect designed for efficacy against all HBV genotypes, including drug resistant strains. Additionally, unlike currently available HBV therapeutics, NUC B1000 is designed to specifically reduce viral antigen load in addition to viral titer, thereby reducing the destructive effects of hepatitis and increasing the potential for resolution of viral infection.

In preparing for the clinical study, an Institutional Review Board at one trial site had specifically suggested that Nucleonics use computer animation to explain the product and its method of action to patients, rather than relying on physicians to explain the relatively complex science underlying the treatment. The use of a computer animation would help to ensure that the technology was presented to each patient in a consistent manner throughout the conduct of the clinical trial.

"Informed consent has evolved of necessity in recent years - patients expect targeted information and feel they deserve to understand the technology surrounding the particular therapy they're being asked to test." explains Beth Anderson, CEO of Arkitek. "Most physicians haven't been exposed to this information either, therefore the burden of explanation falls on the company. With time and resources at a premium, this method offers the best way to address questions or concerns patients may have."

Arkitek Studios, located in Seattle, Washington, specializes in visual content for science, technology and education. For more information, please visit http://www.arkitek.com or http://www.arkitek.com/nucleonics.html.