NINDS Administrative Supplements for Development of Stroke Preclinical Trials Consortia

Notice Number: NOT-NS-06-001

Key Dates
Release Date: August 11, 2005

Issued by
National Institute of Neurological Disorders and Stroke (NINDS), (http://www.ninds.nih.gov/)

Purpose

The National Institute of Neurological Disorders and Stroke intends to publish a Request for Applications (RFA) titled: Stroke Preclinical Trials Consortia. The announcement for this RFA is expected to be published in May 2006 with applications to be submitted and considered for funding in fiscal year 2007. In preparation for the RFA announcement, the NINDS recognizes that an infrastructure for organizing consortia within the stroke community does not currently exist. Therefore, this Notice announces the availability of one-year administrative supplements for NINDS grantees to submit a planning proposal aimed at facilitating the development of interdisciplinary teams to address translational research barriers in stroke and conduct multi-institutional pre-clinical trials. The supplemental plan would evaluate why translation for stroke has not been successful, propose a multi-institutional strategy to address these issues and identify the research resources needed for conducting milestone-driven pre-clinical trials.

Background

Successful translation of pre-clinical studies (e.g., tPA Trial) demonstrates that stroke is treatable in the acute stage of the disorder. However, neuroprotective drugs that worked in animal models for stroke failed in humans trials. This apparent disconnect between laboratory and clinic research is considered a major obstacle to progress toward stroke therapy. The basis for translation failure has been the focus of several stroke conferences and recently, translational research was clearly articulated as a priority through the Stroke Progress Review Group (PRG).

The Stroke PRG emphasized that pre-clinical neuroprotection studies have focused on specific parameters that need to be further evaluated. Animal models focusing on infarct volume, transient ischemia, protection of gray matter, age, gender, short-term outcomes and short treatment windows need to be considered in the context of their translation to the clinical realities. Timing of treatment, dose intensity and drug delivery would also benefit from further investigation. The clinical picture is more complex involving functional outcome, both gray and white matter injury, permanent ischemia, extended treatment windows, and long-term evaluation. The consortium idea is a translational approach to facilitate development of prevention strategies, acute stroke therapy and/or improving chronic behavioral outcomes. Assessment of combination therapies or a single intervention affecting multiple factors and/or delivery of experimental drugs across the blood-brain barrier in stroke would also benefit from the consortium approach. A typical consortium could have up to 5 participating laboratories at different institutions and a separate coordinating center that is responsible for data coordination, site and steering committee communication. Each of the preclinical sites should have two (2) stroke models (species) available with one model common to all sites e.g., the rat. A steering committee of external clinical trialists, NIH staff and consortium members would be responsible for protocol development.

There are many creative strategies that a stroke consortium could pursue to address translational barriers. Organizing by a scientific theme such as immunomodulation, neuroprotection, vasoprotection, plasticity, neurovascular unit, blood-brain barrier or by technology like genomics, imaging or pharmacology could be explored. The initiative encourages alliances among academic institutions, industry and/or government with convergent perspectives on solving the translational challenges in stroke research.

Eligibility

This program will support administrative supplements to Research Project (R01), Javits (R37), Research Centers (P50), Program Project (P01), and Cooperative Agreement (U01) awards to NINDS grantees at domestic institutions. Awards to foreign institutions are not eligible for supplementation under this program. Awards must have at least one year remaining in the project period on December 30, 2005, in order to be eligible. Awards that are in a no-cost extension will not be considered for support under this supplement program. Only one supplement may be requested for any individual award. Applicants are eligible to apply to the RFA in 2006 irregardless of receiving a supplemental award.

How to Apply

This is a one-time announcement. Applications must be received on or before November 11, 2005. Do not send applications to the Center for Scientific Review. Applicants should submit one electronic copy as an e-mail attachment in PDF format and one hard copy (with original signatures of the PI and institutional official) of the application to:

Karen Bateman
Neural Environment Cluster
National Institute of Neurological Disorders and Stroke
Room 2141, Neuroscience Center
6001 Executive Blvd.
Rockville, MD 20892
Email: kb287y@nih.gov

Submitting an Application

Applications for an administrative supplement under this program should use the PHS 398 form (rev. 9/2004; available at http://grants.nih.gov/grants/funding/phs398/phs398.html), and must include the following:

1. Cover letter requesting the supplement, identifying this notice, the number and title of the parent grant, and providing full principal investigator (PI) contact information.

2. Face page.

The title of the project (Box 1) should be the title of the parent award.

This Notice (number and title) should be cited in Box 2, and the “yes” box should be checked.

The Principal Investigator (PI) must be the same as the PI on the parent award. Subproject PIs on P01 and U01 awards are not eligible to apply for these supplements.

The remaining items on the face page should be filled out according to the PHS 398 application instructions.

3. Form page 2 (Description, Performance Sites, Key Personnel, Other Significant Contributors, and Human Embryonic Stem Cells) from PHS 398. The project description is that of the administrative supplement, not the parent grant.

4. Biosketch(es) for any new key personnel or consultants not named in the parent grant. Letters of commitment from these new participants should be included in section J (Consultants) of the Research Plan.

5. Resources page and Other Support page for any new key personnel not named in the parent grant.

6. Modular budget for the supplement with justification for the direct costs being requested. See budget information section below.

7. Research Plan for the supplement, items A-D not to exceed five pages.

This section should include a description of the supplement's specific aims (A), background and significance (B), preliminary studies (C), and research design and methods (D). If collaborators are not at the same institution, describe how they will work together on the supplement project.

Human subjects research (item E of the Research Plan): is not applicable as these supplements are for research on vertebrate animals.

Item F (Vertebrate animals): follow PHS 398 instructions

Items G (Literature Cited), H (Consortium/Contractual Arrangements), I (Resource Sharing) and J (Consultants) should be completed as described in the PHS 398 Instructions.

Review Criteria

Applications will be reviewed administratively by a committee of NIH staff. Awards will be determined on the basis of scientific merit, programmatic relevance, and the availability of funds. All funding decisions are final and are not subject to appeal. The expected supplemental award date will be no later than December 30, 2005.

The RFA applications will be peer-reviewed in fiscal year 2007 and special review criteria will be used and may include: response to addressing translational barriers, research design, available scientific resources, clinical relevance of models, evidence of collaboration, commitment to a team approach and/or organizational strategy. The RFA will have similar milestone-driven requirements defined in the program announcement on the NINDS Cooperative Program in Translational Research (http://grants.nih.gov/grants/guide/pa-files/PAR-02-139.html). The proposed funding mechanism is the U54, Multi-component Translational Research Project-Cooperative Agreement.

Budget Information

Applicants may request up to $50,000 in direct costs for the one-year duration of the administrative supplements under this program. Facilities and Administrative (F&A) costs will be paid at the full, negotiated rate. Although the awarded budgets will be modular, applicants should provide a budget justification that details the direct cost budget items requested. In fiscal year 2006, the NINDS plans to commit approximately $750,000 total cost toward this administrative supplement program, with up to 10 awards anticipated. In fiscal year 2007, the NINDS plans to commit approximately $2.2 Million total cost toward the RFA, with 3-4 consortia awards anticipated.

Inquiries

Applicants are encouraged to discuss their plans for responding to this Notice by phone or e-mail. Direct these inquiries to:

Dr. Thomas P. Jacobs
Stroke Program Director
National Institute of Neurological Disorders and Stroke
Room 2112, Neuroscience Center
6001 Executive Blvd
Rockville, MD 20892
Email: jacobst@ninds.nih.gov


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