Chapter Boundaries

Small clinical trials NIH

The NINDS is committed to identifying effective treatments for neurological disorders by supporting well-executed clinical trials. NINDS will not accept unsolicited SBIR/STTR applications that include clinical trials under the Omnibus solicitation. A clinical trial is a prospective biomedical or behavioral research study of human subjects designed to answer specific questions about the safety, tolerability, efficacy and/or effectiveness of pharmacologic, behavioral, biologic, surgical, or device interventions. This policy does not apply to (1) exploratory IND studies as defined by the FDA or (2) early feasibility studies of devices as defined by the FDA.

NINDS accepts and supports SBIR and STTR clinical trial applications through specific funding opportunities, which can be found on the NINDS SBIR web page. Other human subjects research can also be submitted through the Omnibus solicitation. NINDS may decline funding of any application that includes human subjects for programmatic or administrative reasons. SBIR applicants considering projects involving human subjects research are strongly encouraged to contact Stephanie Fertig or Joanne Odenkirchen (contact information provided below) within the NINDS Office of Clinical Research.

Program Contact

Stephanie Fertig, M.B.A.
Small Business Program
National Institute of Neurological Disorders and Stroke
National Institutes of Health
NSC, Room 2228
6001 Executive Blvd.
Bethesda, MD
(Courier: Rockville, MD 20852)
Tel: (301) 496-1779
Fax: (301) 480-1080

Clinical Trials Contact

Joanne C Odenkirchen, MPH
Office of Clinical Research
National Institute of Neurological Disorders and Stroke
National Institutes of Health
NSC, Room 2178
6001 Executive Blvd.

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Popular Q&A

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What techniques might a small nonprofit use to initiate clinical trials for a promising treatment for a rare disease as inexpensively as possible? - Quora

Sadly clinical trials are never cheap, they take up most of the 500 million to 1 billion USD of the cost of getting a drug to market. Usually they have to give/sell exclusive rights to a bigger company who will sell it at the end. There have been a few unfortunate instances where nonprofit groups release details of a new compound for a disease, but as they are no longer patentable, because they are in the public domain, no company could profitably develop them anymore.

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