A bench-to-bedside approach to translational research is the application of discoveries from basic biomedical and behavioral research toward the diagnosis, treatment or prevention of human disease, with the ultimate goal of improving public health. For the purposes of this FOA, connection to a human clinical condition must be clearly established and clearly stated. The application should seek to translate basic research findings (behavioral or biological) which are known to be directly connected to a human clinical condition, to a practical clinical impact. This FOA is not intended for Phase I/II clinical trials of preliminary efficacy, the extension of ongoing clinical studies, the optimization of current clinical protocols, or pre-translational studies (early stage proof of concept or developmental work premature to direct clinical relevance). Possible goals include, but are not limited to:
1. Biochemical, electrophysiological and behavioral assays to enhance diagnostic capabilities.
2. Pharmacology (toxicity) and pharmacokinetic studies fo candidate therapeutics that have demonstrated potential for the treatment of communication disorders.
3. Pre-clinical animal research for dosage studies and toxicity when subsequent Phase I/II clinical trial is planned.
4. Studies to test the efficacy of highly promising interventions in animal models of disease.
5. Development of tools and techniques for better diagnostics or therapeutics, including but not limited, to drug delivery devices, neuro-electrical stimulators and recording devices.
6. Development of screening test, including biomarkers, to identify individuals at risk for a communication disorder to allow for early intervention.
7. Development and testing of new tools to netter target the treatment to the individual patient and to better predict patient response or prognosis.
8. Development of sensitive and objective tools and technologies for clinical decision matrices.
9. Development and testing of innovative prevention and treatment paradigms and processes using discoveries from biological, psychological, and social sciences.
10.Development and assessment of new data collection, measurement and recording instruments leading to better diagnostic, evaluation and assessment paradigms.
11. Modification of laboratory measures of function or laboratory treatment protocols for use in clinical settings.
1- Declaration of interest: IISPV’s deadline: April 5th, 2014 (firstname.lastname@example.org)
2- NIH Register; create PI account(s); affiliate PI account to IISPV, etc.
3. Letter of Intent: IISPV’s deadline: May 5th, 2014- Official deadline: May 20th, 2014
4. Full proposal: IISPV’s deadline: June 9th, 2014- Official deadline: June 23rd, 2014
1. Letter of Intent: IOfficial deadline: May 20th, 2014
2. Full proposal: Official deadline: June 23rd, 2014
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