NINDS Exploratory Clinical Trials for Small Business (R44)

Jurisdiction:
Federal
Incentive Type:Grant Program
Industries:
Health And Safety, Technology, Research
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 Exploratory Clinical Trials for Small Business is to fund investigator-initiated exploratory clinical trials focusing on products related to the NINDS mission and goals that evaluate drugs, biologics, devices or diagnostics, and surgical, behavioral or rehabilitation therapies. Proposals should aim to further clinical development of the intervention or diagnostic with early designs focusing on important initial information about the intervention such as safety, tolerability, and dosing. Appropriate studies include but are not excluded to:

  • The evaluation and optimization of dosage, formalization, safety, tolerability, or pharmacokinetics of an intervention in healthy volunteers or target populations.
  • Evaluating the amount of sufficient evidence of short-term activity.
  • Selecting or ranking potential interventions or dosing regimens.

Applicants should take note of:

  • Other relevant programs
  • Effective Size
  • Secondary Aims
  • Multiple Trials
  • Regulatory Approvals
  • Biomarkers
  • Adaptive Designs
  • Pharamacometrics
  • Rare Diseases
  • Patient Groups
  • NIH Resources
  • Mobile Technologies
  • NINDS Consultation
  • Meeting specifications of the guidelines

Grant awards typically range between $150,000 and $1,000,000 per project and possible 50% increase upon Congress approval. Applicants are encourage to contact the NIH program officials before proposing anything in excess of the guidelines. 

Applications must be complete and received before the deadline.