Key Dates

Related Announcements

• October 02, 2024 - Analytical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U01 Clinical Trial Optional). See NOFO PAR-25-050. 
• October 02, 2024 - Clinical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U01 Clinical Trial Optional). See NOFO  PAR-25-055.
• January 22, 2024 - Analytical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U44 Clinical Trial Optional). See NOFO PAR-24-098.
• January 22, 2024 - Clinical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U44 Clinical Trial Optional). See NOFO PAR-24-096.

Issued by

National Institute of Neurological Disorders and Stroke (NINDS)

Purpose

This notice is to clarify that only Basic Experimental Studies Involving Humans (BESH) clinical trials are within scope of the above NOFOs (PAR-25-050, PAR-25-055, PAR-24-098, and PAR-24-096). BESH are prospective basic science studies involving human participants (also see NOT-OD-18-212). These studies fall within the NIH definition of a clinical trial and also meet the definition of basic research. The types of studies that applicants should submit in response to these NOFOs include studies that prospectively assign human participants to conditions (i.e., experimentally manipulate independent variables) and that assess biomedical or behavioral outcomes in humans for the purpose of understanding the fundamental aspects of phenomena without specific application towards processes or products in mind.

Applicants whose studies meet the NIH definition of a clinical trial, or think they may meet the definition of a clinical trial, are strongly encouraged to contact the NIH Program Officer (Scientific/Research Contact(s) listed on the NOFO) to discuss whether they meet the BESH definition of a clinical trial.

Applications that do not meet the BESH definition of a clinical trial can be administratively withdrawn without review.

Applicants that wish to conduct a therapeutic clinical trial as part of the biomarker study may consider NeuroNEXT, StrokeNET, or the NINDS Exploratory or Efficacy Clinical Trial NOFOs.

Currently Reads:

Applications Not Responsive to this NOFO

Non-responsive studies include:

• clinical trials or clinical research where the primary intent is to develop therapeutic agents or devices,
• clinical trials or clinical research to evaluate a therapeutic agent or device’s clinical safety, efficacy, effectiveness, and/or clinical management"

Modified to Read: 

Non-responsive studies include:

• clinical trials or clinical research where the primary intent is to develop therapeutic agents or devices,
• clinical trials or clinical research to evaluate a therapeutic agent or device’s clinical safety, efficacy, effectiveness, and/or clinical management,
• clinical trials other than Basic Experimental Studies Involving Humans (BESH).

No other changes to these NOFOs.

Inquiries

Please direct all inquiries to:

Carol Taylor-Burds Ph.D
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-1779
Email: [email protected]