Key Dates

Related Announcements

None

Issued by

National Institute of Neurological Disorders and Stroke (NINDS)

Purpose

This Notice of Information (NOI) is to alert the community that two new Research Opportunity Announcements (ROAs) will soon be issued for the NeuroNEXT Clinical Trials: Stage 1 Preliminary Application and Stage 2 Protocol Application. These ROAs will replace the current Notice of Funding Opportunity ‘NeuroNEXT Clinical Trials (U01 Clinical Trial Optional) PAR-21-223’ which is set to expire on March 06, 2024.

This Notice is being provided to allow potential applicants sufficient time to prepare strong scientific justification and data required for a clinical trial or biomarker validation study to be conducted within the Network for Excellence of Neuroscience Clinical Trials (NeuroNEXT). The ROAs are expected to be published in April 2024, with an anticipated first application receipt date in June 2024.

The ROAs will utilize the OT2 activity code. NINDS intends to utilize Other Transactions Authority (OTA) to fund NeuroNEXT clinical trials, pursuant to the authority described in section 402(n) of the Public Health Service Act, 42 U. S. C. 282(n). Details of the planned ROAs are provided below.

Research Initiative Details

To facilitate cooperation and partnering of public and private funding organizations, universities, academic medical centers, research institutes, contract research organizations, biotechnology companies, and pharmaceutical companies, NINDS has formed the Network for Excellence in Neuroscience Clinical Trials (NeuroNEXT: NINDS NeuroNEXT). NeuroNEXT has a Clinical Coordinating Center (CCC), a Data Coordinating Center (DCC) and geographically distributed clinical sites in the United States.

This clinical research network develops and conducts scientifically sound, possibly biomarker-informed exploratory clinical trials evaluating the most promising therapies emerging from a range of contexts including academic, foundation or industry discoveries. Examples include Phase 2 clinical trials and clinical research studies aimed at validating biomarkers and clinical outcomes in preparation for clinical trials, phase 2-3 trials if warranted by the nature of the studied population (such as rare diseases), and platform trials where applicable. The network is intentionally not focused on a specific disease, but rather has the capacity to coordinate a cadre of specialist investigators to implement studies efficiently in response to disease-specific opportunities.  The network is designed to increase the efficiency of clinical trials, facilitate patient recruitment and retention, increase the quality of neuroscience clinical trials, and enable public-private partnerships.

The planned ROAs will solicit applications from academic investigators, industry applicants, private institutions, or nonprofits that will be reviewed in a two-stage process. It is recommended that applicants submit an inquiry to obtain guidance regarding whether NeuroNEXT may be an appropriate funding mechanism.

• Stage 1: The Stage 1 application must include scientific background information supporting the asset and proposed clinical trial to be conducted within NeuroNEXT.  Applications for drugs or biologics should provide compelling scientific evidence that the investigational agent proposed for study will reach/act upon the designated target or that its mechanism of action strongly suggests it will be of benefit in ameliorating a specific aspect of the disease. The proposed asset must have completed first-in-human studies and have preliminary information on safety in humans and sufficient data to inform dose selection for a phase 2 clinical trial.  Stage 1 Preliminary Applications will be received and reviewed on a rolling basis. The review includes an independent /objective review by a panel of external experts convened by the NINDS.  No funding is provided at Stage 1 application.
• Stage 2: After a successful review of the Stage 1 application and upon receiving an invitation to proceed to Stage 2, the Stage 1 applicant will work with NeuroNEXT to further develop the clinical trial protocol. At Stage 2, the NeuroNEXT CCC becomes the applicant of record for the Stage 2 Protocol Application. The Stage 2 application will undergo an objective scientific review process., and the protocols selected following the review will be presented to the National Advisory Neurological Disorders and Stroke Council (NANDS)  for funding approval.  If approved by the NANDS Council, a funding decision will be made by the NINDS Director. If funded, the OTA trial funds will be released to the NeuroNEXT CCC, and the NeuroNEXT CCC then administers the funds to other NeuroNEXT research components as appropriate.

This Notice encourages those with relevant expertise to consider applying to the planned ROAs.

Further details will be outlined in the forthcoming ROAs. Once the ROAs are published, they will be accessible through the following link: https://www.ninds.nih.gov/funding/find-funding-opportunities/research-opportunity-announcements

APPLICATIONS ARE NOT BEING SOLICITED AT THIS TIME.

Inquiries

Please direct all inquiries to:

Sophie Cho, MD
National Institutes of Neurological Disorders and Stroke
Email:  hyunjoo.cho@nih.gov