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


Notice Number: NOT-NS-11-027

Update: The following update relating to this announcement has been issued:

Key Dates

Release Date:  September 1, 2011
Response Date: To assure consideration, comments must be received by (Extended to October 7, 2011 per NOT-NS-11-031), Originally September 30, 2011   

Related Notices

NOT-NS-11-020

Issued by

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:

1.  Define an optimal strategy for collecting and broadly disseminating de-identified clinical and imaging data, if any.

2.  The key factors to consider when coordinating data from multiple studies through a single data management resource, if any. 

3.  The level and type of quality control that should be adopted across datasets.

4.  Describe the most common problem experienced by data users when accessing or analyzing shared data provided through a data management resource.

5.  Describe the key features that assure patient privacy concerns are addressed when broadly sharing de-identified clinical data.

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:

1.  Identify a data management resource that exemplifies ease of use and access for the user, if any.

2.  The limitations for assessing and analyzing imaging data from longitudinal studies which utilize a data management or coordinating center for data access, if any.

3.  Assuming policies are in place for data acquisition, describe the most common roadblocks to data access and utilization when data is distributed from a data management or coordinating center.

General Information

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

1.  Please identify the nature of your interest in the area of data management services for Parkinson's disease biomarkers (i.e. are you a biomedical or clinical researcher, a member of an advocacy or community group, or other?).

2.  If you are a member of a particular advocacy or professional organization, please indicate the name of the organization.

3.  Please indicate your main area of research interest.

4.  Your name.

5.  Your email address.

Responses

Responses must be submitted electronically using the web-based form (http://www.ninds.nih.gov/dmr) and will be accepted through September 30, 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

Please direct all inquiries to:

Margaret Sutherland, PhD
Program Director, Neurodegeneration Cluster
NINDS / NIH
6001 Executive Blvd., Rm 2222
Bethesda, MD 20892
Phone: 301-496-5680
Fax: 301-480-1080
E-mail: sutherlandm@ninds.nih.gov


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