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.