NINDS Direct Phase II SBIR Grants to Support Exploratory Clinical Trials
| Jurisdiction: |
Federal
|
| Incentive Type: | Grant Program |
| Industries: |
Research, Health And Safety, Medical
|
| Eligible Sector: |
Business
|
| Category: |
Financial Incentive
|
| Time Period: |
FY 2015
|
| Governing Body: | National Institutes of Health |
| What’s it worth?: | Not mentioned |
The purpose of the NINDS Direct Phase II SBIR Grants to Support Exploratory Clinical Trials is to demonstrate the scientific and technical merit of previously approved Phase I applications research. Ideal projects include:
- Phase 1 and 2 single-site clinical studies
- Phase 2b multicenter clinical studies
- Evaluation and optimization of the dose, formulation, safety, tolerability or pharmacokinetics of an intervention
- Evaluation of intervention that produces sufficient evidence of short-term activity
- Compare and test the best of two or more intervention or dosing regimens
This program is not meant to be used to fund clinical trials aimed establish or confirm definitive efficacy. Eligible participants should take note of:
- Other relevant programs
- Effective size
- Secondary aims
- Multiple trials
- Exploratory IND/Early Feasibility studies
- Regulatory approvals
- Biomarkers
- Adaptive designs
- Simulations
- Pharmacometrics
- Rare diseases
- Patient groups
- NIH Resources
- Mobile technologies
- Consultation with NINDS
All applicants must meet the following criteria.
