HealthMark Multimedia Announces Grant from NIH to Develop Onlined Informed Consent for Clinical Trials
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.
Washington DC, (PRWEB) March 10, 2005 -- HealthMark Multimedia announces
receipt of SBIR grant from NIH to develop a multimedia-enhanced online informed
consent for clinical trials.
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.
About HealthMark
Multimedia
HealthMark Multimedia, LLC, a certified woman-owned business,
combines graphics, audio, video and text to develop award-winning interactive,
user-friendly software and Web sites for:
• patient treatment and self-care
decisions
• continuing education for health care professionals
• disease
prevention and health promotion materials for parents and
children
HealthMark Multimedia uses an established network of medical
experts, as well as patients and lay caregivers to review and test products for
accuracy, relevance, and usefulness.
Since 1997 HealthMark Multimedia
has been funded by the National Cancer Institute, Centers for Disease Control,
American Psychological Association, and other public and private organizations
needing specialized health communications.
For further information about
the company or its products, contact HealthMark Multimedia: 1828 L Street, NW,
#250, Washington, DC 20036; Telephone: 202-265-0033; Fax: 202-448-6188.
HealthMark Multimedia's home page can be found at www.HealthMarkMultimedia.com.
Contact: Susan Brink,
Principal
HealthMark Multimedia, LLC
PH: 202-265-0033, Ext. 201
Email:
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Source : http://www.prweb.com/releases/2005/3/prweb216284.htm