NeuroNEXT Small Business Innovation in Clinical Trials Direct to Phase II (U44)

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

The purpose of the NeuroNEXT Small Business Innovation in Clinical Trials Direct to Phase II program is to facilitate collaboration efforts between research institutions to conduct exploratory clinical trials of investigational agents. Appropriate studies include but are not excluded to:

  • The evaluation and optimization of dosage, formulization, 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.
  • Evaluation of biological activity relative to clinical endpoints.

Eligible participants should note the following:

  • Applicants are required to incorporate the NeuroNEXT infrastructure into their proposed study.
  • Rationale
  • Secondary Aims
  • NIH understands that devices can vary greatly
  • NIH Resources are available for applicants
  • Mobile Technologies

Grant awards typically do not exceed $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.