INDS Renewal Awards of SBIR Phase II Grants (Phase IIB) for Exploratory Clinical Trials and Clinical Research (R44)

Incentive Type:Grant Program
Research, Health And Safety, Medical
Eligible Sector:
Financial Incentive
Time Period:
FY 2015
Governing Body:National Institutes of Health
What’s it worth?:Not mentioned

The purpose of the NINDS Renewals Awards of SBIR Phase II Grants for Exploratory Clinical Trials and Clinical Research is to extend the demonstration of the scientific and technical merit of previously approved Phase II applications research because some project require more than others. 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.