Update: The following update relating to this announcement has been issued:
- May 8, 2014 - See Notice NOT-NS-14-027. Notice of Intent to Publish a Funding Opportunity Announcement for Biomarker Discovery through the Use of Data and Resources Developed by the NINDS Parkinson's Disease Biomarker Program (PDBP) (U01).
Release Date: March 20, 2013
National Institute of Neurological Disorders and Stroke (NINDS)
The creation of the NINDS Parkinson’s Disease Biomarkers Program (PDBP) has resulted in an opportunity for a common platform for exchanging data, protocols, and biospecimens for Parkinson’s Disease (PD) Biomarkers Research. NINDS expects that projects studying Parkinson’s Disease biomarkers will utilize the PDBP Data Management Resource (DMR), which NINDS has created in order to accelerate progress in this field.
Background
The overall goal of the NINDS Parkinson’s Disease Biomarkers Program (PDBP) is to allow the rapid identification and development of potential biomarkers to improve the efficiency and outcome of Phase II or III clinical trials of neuroprotective agents in Parkinson’s Disease. In order to accomplish this goal, it is essential that there be a concerted effort to collect biospecimens, imaging, and clinical data using standardized approaches. Furthermore, a collaborative environment will be essential for success of this program; therefore sharing standards and policies have been established.
Brief Summary of PDBP Policies
Details regarding PDBP structure and policies can be found at https://pdbp.ninds.nih.gov/index.jsp. A brief selection of policy highlights includes:
- Clinical and laboratory data are expected to be entered into and shared via the PDBP Data Management Resource (DMR). Costs related to utilization of this resource, and any costs associated with the inclusion of legacy data, should be included in the application budget.
- Clinical studies are expected to use a core set of defined NINDS Clinical Data Elements (CDEs), see https://pdbp.ninds.nih.gov/jsp/healthcare-professionals.jsp. Note that clinical trials (interventional studies) are not included in the PDBP. For studies which have both an interventional and a biomarkers component, that latter component would be expected to participate per the specifications of this notice in the PDBP.
- Consent forms for clinical studies should be consistent with those listed at https://pdbp.ninds.nih.gov/assets/PDBP%20DMR%20Consent%20Elements.pdf.
- All eligible biological specimens are expected to be banked with the NINDS Repository.
- Sharing of data and biospecimens with qualified researchers in both academics and industry is expected.
Selected NINDS grantees will be invited to attend two meetings per year to discuss PDBP progress and policy, and be included in the PDBP Steering Committee, as a part of the consortium. Plans for the costs of attending up to two PDBP organizational meetings per year should be included in the application budget.
Implementation
This policy will apply to all NINDS projects in PD Biomarkers research (including R01, U01, P50, P01, and other mechanisms). Because extensive programmatic input and coordination are required for NINDS PDBP projects, successful applications may be converted to cooperative agreements (U mechanism).
Applicants who are proposing PD biomarker studies are urged to contact their NINDS program director prior to submission in order to allow ample planning for coordination with the PDBP and with PDBP policies.
Please direct all inquiries to:
Katrina Gwinn, MD
Program Director
Division of Extramural Research
National Institute of Neurological Disorders and Stroke
Telephone: 301-496-5745
Email: gwinnk@ninds.nih.gov
Website: Pdbp.ninds.nih.gov
and Human Services (HHS)
