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Collaborative Antiviral Study Group (CASG)
Application Process
Investigators may submit concepts for clinical trials to evaluate therapeutic antiviral regimens or clinical studies to support future therapeutic or medical management of viral diseases to the Project Officer or to the Principal Investigator of the contract directly.
The request must include:
A description of the overall study, including the unmet medical need(s) to be addressed by the study and, for example, how data obtained via these contract resources will support the development of therapies for the viral disease of concern (e.g. pharmacokinetic data to determine appropriate dosing of a drug in a special population).
Background and significance including, for example, a concise scientific justification for the proposed study. The justification should address the potential impact of the study on treatments and/or medical management of the disease to be studied.
Preliminary data that support the request to conduct the proposed study. Examples include: a summary of available safety data (i.e. toxicology data and previous human experience); drug disposition data (i.e. pharmacokinetics and metabolism); and/or information on feasibility of outcome measures.
A list of other governmental and non-governmental funded and pending support and a brief description of activities relevant to the request.
Description of the overall plan for advancing the product beyond completion of the services requested, if appropriate.
The Project Officer, investigator, and contractor work together to develop the concept to produce maximum data within budgetary constraints.
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Contact Info
DMID Contact: Walla Dempsey
E-mail:
wdempsey@niaid.nih.gov
Principal Investigator: Richard Whitley
E-mail:
rwhitley@peds.uab.edu
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Contact Info
DMID Contact: Walla Dempsey
E-mail:
wdempsey@niaid.nih.gov
Principal Investigator: Richard Whitley
E-mail:
rwhitley@peds.uab.edu
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Last Updated June 25, 2008
National Institute of Allergy and Infectious Diseases (NIAID)
National Institutes of Health (NIH)
Department of Health and Human Services (HHS)