Key Dates

Related Announcements

November 27, 2023 - NINDS Exploratory Clinical Trials for Small Business (R43/R44 Clinical Trial Required). See NOFO, PAR-23-311.

November 27, 2023 - NINDS Exploratory Clinical Trials for Small Business (R41/R42 Clinical Trial Required). See NOFO, PAR-24-044.

Issued by

National Institute of Neurological Disorders and Stroke (NINDS)

Purpose

These NOFOs require a Plan for Enhancing Diverse Perspectives (PEDP). Applications that fail to include a PEDP will be considered incomplete and will be withdrawn. However, the NOFOs list PEDP under non-responsive criteria in Section I where it does not belong as it is not responsive criteria. Please see Section IV.2 under Other Attachments for all instructions regarding PEDP. This applies to all receipt dates after September 5, 2024.

Section I

Currently Reads:

Applications Not-Responsive to this NOFO:

Non-responsive applications will not be reviewed.

• Applications primarily intended to discover biomarkers. For Biomarker funding opportunities at NINDS please visit: https://www.ninds.nih.gov/Current-Research/Focus-Tools-Topics/Biomarkers.
• Applications for Phase 3 trials. These projects should be submitted under PAR-21-237, NINDS Efficacy Clinical Trials.
• Applications for a clinical trial where the primary aim is to establish or confirm definitive efficacy. Applications to implement definitive efficacy trials (e.g., Phase 3 trials of drugs or Pivotal device trials) should be submitted to PAR-21-237, NINDS Efficacy Clinical Trials.
• Trials where the primary objective is to estimate intervention effect size to be used in power calculations for a future efficacy clinical trial.
• Multi-site clinical trials with more than three clinical sites. These trials may be supported through NINDS clinical trial networks, such as StrokeNet (http://www.nihstrokenet.org), NeuroNEXT (http://www.neuronext.org) and EPPIC-Net (https://www.ninds.nih.gov/Current-Research/Trans-Agency-Activities/NINDS-Role-HEAL-Initiative/NINDS-Role-HEAL-Initiative-EPPIC).
• Preclinical activities to support filing of an IND or IDE followed by clinical trial activities supported by this IND/IDE.
• Applications that fail to include a PEDP

Revised to Read:

Applications Not-Responsive to this NOFO:

Non-responsive applications will not be reviewed.

• Applications primarily intended to discover biomarkers. For Biomarker funding opportunities at NINDS please visit: https://www.ninds.nih.gov/Current-Research/Focus-Tools-Topics/Biomarkers.
• Applications for Phase 3 trials. These projects should be submitted under PAR-21-237, NINDS Efficacy Clinical Trials.
• Applications for a clinical trial where the primary aim is to establish or confirm definitive efficacy. Applications to implement definitive efficacy trials (e.g., Phase 3 trials of drugs or Pivotal device trials) should be submitted to PAR-21-237, NINDS Efficacy Clinical Trials.
• Trials where the primary objective is to estimate intervention effect size to be used in power calculations for a future efficacy clinical trial.
• Multi-site clinical trials with more than three clinical sites. These trials may be supported through NINDS clinical trial networks, such as StrokeNet (http://www.nihstrokenet.org), NeuroNEXT (http://www.neuronext.org) and EPPIC-Net (https://www.ninds.nih.gov/Current-Research/Trans-Agency-Activities/NINDS-Role-HEAL-Initiative/NINDS-Role-HEAL-Initiative-EPPIC).
• Preclinical activities to support filing of an IND or IDE followed by clinical trial activities supported by this IND/IDE.

No other changes to these NOFOs.

Inquiries

Please direct all inquiries to:

Emily Caporello, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-1778
Email: [email protected]