Exploratory Clinical Trials for Small Business Grant Program

The National Institutes of Health, more typically called NIH, is a government agency operating in the United States Department of Health and Human Services that is basically accountable for ensuring and supporting all the nation’s biomedical and health-related research studies.

The grants and programs of the NIH are all designed to contribute to the realization of its overall agency mission which is to”seek fundamental knowledge about the nature and behavior of living systems and the application of that information to improve health, lengthen life, and cut back the burdens of sickness and disability.”

In accordance with this mission, the National Institutes of Health has formed a collaboration with the National Institute of Neurological Disorders and Stroke (NINDS) to develop the Exploratory Clinical Trials for Small Business Grant Program whereby they aim to build a vehicle for Small Business Concerns (SBCs) in the process of submitting Small Business Technology Transfer (STTR) grant applications for exploratory clinical trials directly to the NINDS.

The NIH and NINDS have stipulated that the trials and research studies that will be funded under this programme are those that are concentrating on products that are associated to the goals and missions of the NINDS, such as an analysis of drugs, biologics, devices, or diagnostics, and even surgical, behaviour or rehabilitation treatments.

Fundamentally, the Exploratory Clinical Trials for Small Business Grant Program has been established to help diminish or eradicate the burden that’s experienced by people who are afflicted with neurological defects.

That said, the NINDS seeks to provide support to small businesses in their quest to develop emerging technologies that will potentially be of use to the objective in focus.

The examples of the types of studies that’ll be supported under this programme are those that aim to:

a) Evaluate and optimize the dose, formulation, safety, tolerability/pharmacokinetics of a certain intervention or diagnostic test in healthy volunteers or the target population

b) Potential clinical verification of a diagnosis

c) Asses whether or not an intervention produces enough proof of short term activity in a human”proof of concept” trial

d) Decide the best of several potential interventions or dosing programmes that’ll be evaluated in a subsequent trial, based primarily on tolerability, biological activity, or initial clinical efficiency.

The NIH and NINDS are ready to administer a funding amount of $750,000 per grant awardee to support the execution of this programme.

The establishments and organizations who will be considered eligible to submit an application under this program are those Small Business Concerns that meet the following criteria:

a) SBCs that are generally organized for profit and is found and operating in the United States, and makes a substantial contribution to the U. S. economy through payment of taxes or use of American products, materials or labor;

b) SBCs that are in the legal form of an individual proprietorship, partnership, limited liability firm, enterprise, joint venture, association, trust or cooperative;

c) SBCs that do not have more than 500 workers

d) SBSs that are at least 51% owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States.