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NINDS Request for Information (RFI) on Creating a Data Management Resource for the Parkinson's Disease Biomarkers Program


Notice Number: NOT-NS-11-027

Key Dates
Release Date:
Response Date: To assure consideration, comments must be received by October 7, 2011

Related Notices
NOT-NS-11-020

Issued by
The National Institute of Neurological Disorders and Stroke (NINDS)

Purpose
As stated in the recent Notice (NOT-NS-11-020), the NINDS intends to establish a Parkinson's Disease Biomarkers Program (PDBP). Initially, the PDBP will have three major components:
1) Discovery projects to identify promising biomarkers; 2) A resource for the banking and sharing of existing and prospective biological samples; 3) A Data Management Resource (DMR).

The goal of this RFI is to seek public comment on considerations in the development of the Data Management Resource for the Parkinson's Disease Biomarkers Program (PDBP). This resource will receive, process, and distribute standardized clinical, imaging, biological, and molecular data from discovery and other Parkinson's biomarkers projects. Both positive and negative data will be included in the DMR. Information obtained via this RFI will help the NINDS in designing strategies for establishment of the DMR and for data coordination, integration, and sharing across the PDBP program.

Background
Recently, there has been considerable progress in our understanding of the biology of Parkinson's disease. However, inadequate measures of disease progression, the limited ability to detect neurodegeneration prior to the onset of motor signs, and the lack of assays that measure target engagement by potential therapeutics all currently impede therapy development. To overcome these obstacles, the NINDS intends to establish a Parkinson's Disease Biomarkers Program (PDBP) (as stated above and in NOT-NS-11-020). The goal of this program is to facilitate the development of neuroprotective agents that slow or halt the progression of Parkinson's disease. By providing shared, high quality resources, the PDBP program will coordinate the efforts of multiple stakeholders. It will facilitate both clinical and laboratory-based discovery projects designed to lead to the validation of candidate markers for pre-symptomatic diagnosis and monitoring of disease progression. These markers will ultimately be critical for designing effective Phase II and III clinical trials.

Information Requested

Data Management
This RFI invites input from the broader biomedical research community on innovative strategies and practices that have proven successful in Data Management for projects requiring receipt, maintenance, storage, analysis, and distribution of a variety of data types (clinical, genetic, imaging, molecular, etc.) and formats. Your input can include the following concerns:




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Data Utilization 
This RFI also invites input from investigators who have accessed and utilized data from broadly available data resources. Your input can include the following concerns:




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General Information
Note: All of the following fields are optional. Proprietary, classified, confidential, or sensitive information should not be included in your response.

   
   
   
   

Responses

Responses must be submitted electronically using the web-based form (http://www.ninds.nih.gov/dmr) and will be accepted through October 7, 2011. Any personal identifiers (e.g., names, addresses, email addresses, etc.) will be removed when responses are compiled. Proprietary, classified, confidential, or sensitive information should not be included in your response. Replies to individual questions are optional, and the site will permit anonymous responses. The information provided will be analyzed and may appear in various reports.

This Request for Information (RFI) is for planning purposes only and is not a solicitation for applications or an obligation on the part of the United States (U.S.) Government to provide support for any ideas identified in response to it. Please note that the U.S. Government will not pay for the preparation of any comment submitted or for its use of that comment.

Inquiries

For further information contact:

Margaret Sutherland, Ph.D.
Program Director, Neurodegeneration Cluster
NINDS/NIH
6001 Executive Blvd Room 2222
Phone: (301) 496-5680
Fax: (301) 480-1080
Email: sutherlandm@ninds.nih.gov

Last updated September 19, 2014