Arkitek Studios, a US company that specialises in developing visual content for science, technology and education, is claiming the first-ever use of 3D animation as part of the informed consent procedure for a Phase I clinical trial.
The animation was created to help patients understand the scientific rationale behind an experimental gene silencing therapy for hepatitis B under development by Nucleonics, a privately held biotechnology company based in Horsham, Pennsylvania. Nucleonics recently started treating patients in a Phase 1 safety study of NUC B1000 for chronic hepatitis B virus (HBV) infection.
NUC B1000 is an expressed interfering RNA (eiRNA)-based product, consisting of a plasmid DNA construct designed to produce four short interfering RNA (siRNA) molecules. These are formulated with a proprietary cationic-lipid delivery system. Each of the four siRNA molecules targets a different sequence of the HBV genome, with the potential collectively to eliminate all RNA species produced by the hepatitis B virus within an infected cell. The result, Nucleonics explains, is “a potent antiviral effect designed for efficacy against all HBV genotypes, including drug-resistant strains”.
In preparing for the study, noted the Seattle, Washington-based Arkitek, an Institutional Review Board at one trial site had specifically suggested that Nucleonics should use computer animation to explain the product and its relatively complex mode of action to patients, rather than relying on physicians to do so. This would also help to ensure the technology was presented to each patient in a consistent manner throughout the 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,” commented Beth Anderson, chief executive officer 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.”
