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

FOA Number: 


Release Date: 

Thursday, September 1, 2011

FOA Expiration Date: 

Wednesday, January 1, 2020

FOA Announcement Type: 


Funding Opportunity Purpose: 

NINDS Request Information RFI) Creating Data Management Resource the Parkinson's Disease Biomarkers Program Notice Number: NOT-NS-11-027 Update: following update relating this announcement been issued: September 30, 2011 - Notice NOT-NS-11-031. Notice extend response date. Key Dates Release Date: September 1, 2011 Response Date: assure consideration, comments must received Extended October 7, 2011 per NOT-NS-11-031), Originally September 30, 2011    Related Notices NOT-NS-11-020 Issued National Institute Neurological Disorders Stroke NINDS) Purpose stated the recent Notice NOT-NS-11-020), NINDS intends establish Parkinson’s Disease Biomarkers Program PDBP).  Initially, PDBP have three major components: 1) Discovery projects identify promising biomarkers; 2) resource the banking sharing existing prospective biological samples; 3) Data Management Resource DMR).  goal this RFI to seek public comment considerations the development the Data Management Resource the Parkinson's Disease Biomarkers Program PDBP).  resource receive, process, distribute standardized clinical, imaging, biological, molecular data discovery other Parkinson’s biomarkers projects.  Both positive negative data be included the DMR. Information obtained via RFI help NINDS designing strategies establishment the DMR for data coordination, integration, sharing across PDBP program. Background Recently, has considerable progress our understanding the biology Parkinson’s disease.  However, inadequate measures disease progression, limited ability detect neurodegeneration prior the onset motor signs, the lack assays measure target engagement potential therapeutics currently impede therapy development.  overcome obstacles, NINDS intends establish Parkinson’s Disease Biomarkers Program PDBP) stated above in NOT-NS-11-020).  goal this program to facilitate development neuroprotective agents slow halt progression Parkinson’s disease.  providing shared, high quality resources, PDBP program coordinate efforts multiple stakeholders.  will facilitate both clinical laboratory-based discovery projects designed lead the validation candidate markers pre-symptomatic diagnosis monitoring disease progression. markers ultimately critical designing effective Phase II III clinical trials.  Information Requested Data Management RFI invites input the broader biomedical research community innovative strategies practices have proven successful Data Management projects requiring receipt, maintenance, storage, analysis, distribution a variety data types clinical, genetic, imaging, molecular, etc.) formats.  input include following concerns: 1.  Define optimal strategy collecting broadly disseminating de-identified clinical imaging data, any. 2.  key factors consider coordinating data multiple studies through single data management resource, any.  3.  level type quality control should adopted across datasets. 4.  Describe most common problem experienced data users accessing analyzing shared data provided through data management resource. 5.  Describe key features assure patient privacy concerns addressed broadly sharing de-identified clinical data. Data Utilization RFI also invites input investigators have accessed utilized data broadly available data resources.  input include following concerns: 1.  Identify data management resource exemplifies ease use access the user, any. 2.  limitations assessing analyzing imaging data longitudinal studies utilize data management coordinating center data access, any. 3.  Assuming policies in place data acquisition, describe most common roadblocks data access utilization data distributed a data management coordinating center. General Information Note: of following fields optional. Proprietary, classified, confidential, sensitive information should be included your response.  1.  Please identify nature your interest the area data management services Parkinson's disease biomarkers i.e. you biomedical clinical researcher, member an advocacy community group, other?). 2.  you a member a particular advocacy professional organization, please indicate name the organization. 3.  Please indicate main area research interest. 4.  name. 5.  email address. Responses Responses must submitted electronically using web-based form will accepted through September 30, 2011.  Any personal identifiers e.g., names, addresses, email addresses, etc.) be removed responses compiled.  Proprietary, classified, confidential, sensitive information should be included your response. Replies individual questions optional, the site permit anonymous responses. information provided be analyzed may appear various reports. Request Information RFI) for planning purposes only is a solicitation applications an obligation the part the United States U.S.) Government provide support any ideas identified response it.  Please note the U.S. Government not pay the preparation any comment submitted for use that comment. Inquiries Please direct 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:

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