HealthMark Multimedia in the News:

For Immediate Release

Contact: Susan Brink, Principal
HealthMark Multimedia, LLC
PH: 202-448-6150, Ext. 201
Email:

HealthMark Multimedia announces receipt of SBIR grant from NIH to develop a multimedia-enhanced online informed consent for clinical trials.

ConsentSolutions™ to provide online informed consent for clinical trials.

Washington, DC, January 2, 2005 - HealthMark Multimedia, LLC, has been awarded a National Cancer Institute Small Business Innovation Research (SBIR) grant to produce an online product to facilitate clinical trial investigators in the development of informed consent documents and a media-enhanced information and educational support toward greater informed consent for potential clinical trial subjects.

The investigator arm of ConsentSolutions™ will be developed to provide a media-enhanced database of the basic elements of an online clinical trial informed consent document. Examples of the interactive elements include: dictionary terms in audio-visual format, as well as other tested patient information and decision-making tools for the Learn More section. The database will be formulated to meet specific institutional IRB requirements. After development and IRB approval, each informed consent document will reside on a secure server with access restricted by personal access codes. In addition, approved informed consent documents will be able to be amended to reflect changes in the protocol. A back office component will be developed to allow clinical trial investigators to monitor patients' use of the online informed consent by tracking time, date, and use data.

The patient arm of ConsentSolutions™ will be developed to provide qualified potential subjects with the IRB-approved text for the clinical trial informed consent with options for audio-visual presentation in multiple languages. Clear, concise information and interactive tools to help users address decisions about clinical trials will be supported in a linked Learn More section. Anticipated patient tools include: self-assessment questions to test understanding, an audio-visual dictionary, questions for the health care provider, and a decision-making grid. The interactive tools will be designed to help patients to reach a decision by drawing on their own values and preferences. Users will be able to download the informed consent document and the tools for printing.

After initial development, ConsentSolutions™ will be tested against the traditional paper-based informed consent for ease of use and level of patient preference; quality and quantity of subject comprehension; relative percentages of enrollment, compliance, and retention of study subjects; and comparisons of direct and indirect costs. Published data indicate that the multimedia-enhanced online informed consent double enrollment rates, that knowledge is increased 40%, 35% fewer candidates required screening due to decreased drop-out rates; and more efficient use of costly researchers' time.