Notice Number: NOT-NS-08-003
Release Date: October 16, 2007
National Institute of Neurological Disorders and Stroke (NINDS) (http://www.ninds.nih.gov/)
The National Institute of Neurological Disorders and Stroke (NINDS) is considering issuing contracts to identify two NINDS “Facility of Research Excellence in Spinal Cord Injury” (FORE-SCI) sites to conduct research to replicate promising studies that could lead to new and effective treatments for spinal cord injury (SCI).
The NINDS is the lead NIH Institute for funding of SCI research, and the major supporter of basic science to develop novel therapeutic strategies for this disorder. In the United States, the incidence of SCI is approximately 11,000 per year. In recent years, many laboratories have reported anatomical and behavioral indications that spinal cord tissue can be preserved and/or spinal circuitry regenerated in animal SCI models. These novel findings have led to the expectation that these strategies could be translated into effective clinical treatments for SCI. While there remains some question as to how much and what type of preclinical data will predict success in clinical trials, there is agreement that proof of principle experiments should be replicated independently in multiple laboratories and/or in more than one type of animal model. To date, a significant barrier to the development of promising avenues to treatments for patients is the lack of independent confirmation of preclinical results. This inability to confirm and characterize potentially important outcomes with confidence has prevented new approaches from moving forward to clinical studies.
Thus, a significant number of potential therapeutic approaches to protect and repair the injured spinal cord have been identified, but few of these have reached the stage of clinical trials and none have been successfully translated into clinical practice. Among several key factors limiting successful translation, assessing the quality and reproducibility of the reported results is one that can be directly addressed by attempting to replicate and confirm promising studies independently. Based on a series of workshops, NINDS identified several unmet needs in the field of SCI and issued a Broad Agency Announcement in 2002 to develop contracts for FORE-SCI for training in SCI research methods, replication studies, and development of improved outcome assessments. To date, two FORE-SCI contracts have supported attempts to replicate published preclinical studies that show promise for development into new treatments for SCI. Unfortunately and unexpectedly, none of these attempts have succeeded in confirming the functional gains reported in the original studies. A report published in 2005 by the Institute of Medicine emphasized the continuing need for replication of preclinical studies, naming this as one of six criteria for drug therapies entering clinical trials. This report states that “an emphasis on the replication of preclinical studies (replication studies) between laboratories is needed,” citing the FORE-SCI centers as prototypes for this effort. Further, it suggests that the effort also include “broader studies that not only replicate a previous study but also include novel elements in the experiment.” The NINDS now seeks to re-compete this effort by soliciting proposals for two centers to undertake replication studies to confirm exciting findings from the spinal cord injury field.
GOALS AND OBJECTIVES OF THE CONTRACT:
The proposed solicitation is to identify two NINDS “Facility of Research Excellence in Spinal Cord Injury” (FORE-SCI) sites to conduct research to replicate promising studies that could lead to new and effective treatments for SCI. The role of these two FORE-SCI centers will be to review and replicate novel treatments for SCI and to compare the efficacy of different treatments in a standardized environment with a minimum of variability in surgery, animal care, outcome evaluation and cellular analyses. It is anticipated that these centers will replicate at least one study per year, and make the results of these studies readily available to the SCI research community through peer-reviewed publications, presentations and other appropriate venues. A successful program will demonstrate the capability to utilize multiple models of rodent spinal cord injuries, outcome measures and other experimental protocols to be used in the studies selected for replication.
SPECIFIC PERFORMANCE GOALS OF THIS CONTRACT ARE:
1. To assess the scientific literature to select and then attempt to replicate promising, published preclinical studies of therapies that could lead to effective treatments for human SCI;
2. To compare the efficacy of different treatments in a standardized environment with a minimum of variability in surgery, animal care, outcome evaluation and cellular analyses; and
3. To promptly report the methodology and results of the replication study to the research community.
Information in the following areas will aid in the design of the proposed solicitation. We ask that interested organizations comment on critical criteria to be included in the solicitation. The information supplied in response to this request need not be limited to these areas.
o Appropriate length of time for completion of a replication study for (a) acute & subacute and (b) chronic therapeutic strategies.
o Dissemination of results, positive or negative: Will peer-reviewers approve pure replication studies and, if not, what other options dissemination venues are appropriate?
o Best scientific approach to confirmation of published results (i.e., should studies be restricted to pure replication, vs. addition of control groups/models/outcomes or other experiment design elements).
This Request for Information (RFI) is for information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the Government. The Government does not intend to award a contract on the basis of responses nor otherwise pay for the preparation of any information submitted or the Government’s use of such information. Acknowledgement of receipt of responses will not be made, nor will respondents be notified of the Government’s evaluation of the information received. However, should such a requirement materialize, no basis for claims against the Government shall arise as a result of a response to this request for information or the Government’s use of such information as either part of our evaluation process or in developing specifications for any subsequent requirement. Responses will be held in a confidential manner. Any proprietary information should be so marked.
All respondents are asked to indicate the type and size of your business organization, e.g., Large Business, Small Business, Veteran-owned Small Business, Service-disabled Veteran-Owned Small Business, Hubzone Small Business, Small Disadvantaged Business, Women-Owned Business, 8(a), Historically Black College or University/Minority Institution (HBCU/MI), educational institution, profit/non-profit hospital, or other nonprofit organization.
Responses should be identified with NINDS RFI NS-08-003 and are due by October 26, 2007. Please submit two copies of your response to:
Laurie A. Leonard
NINDS R&D Contracts Management Branch
National Institute on Drug Abuse
6001 Executive Boulevard, Room 3287, MSC 9531
Bethesda, Maryland 20892-9531
(for FedEx or courier, use: Rockville, MD 20852)
Phone Number: 301-496-1813
Fax Number: 301-402-4225
E-mail responses, sent to LL44S@nih.gov will also be accepted.
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NIH Funding Opportunities and Notices
Office of Extramural
National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
Department of Health
and Human Services (HHS)
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