Notice of Intent to Publish a Request for Applications for Core Cohort Discovery or Validation Studies in the Parkinson's Disease Biomarkers Identification Network (PD-BIN) (U01)

Notice Number: NOT-NS-11-001

Release Date: November 10, 2010

National Institute of Neurological Disorders and Stroke (NINDS)

The National Institute of Neurological Disorders and Stroke intends to promote a new initiative by publishing a Funding Opportunity Announcement (FOA) to solicit applications for hypothesis-driven clinical research studies that will accelerate and augment the discovery of biomarkers as a component of the NINDS Parkinson's Disease Biomarkers Identification Network (PD-BIN).

This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects.

The FOA is expected to be published in late spring, 2011 with an expected receipt date in fall, 2011.

This FOA will utilize the U01 activity code. Details of the FOA are provided below.

This Notice encourages investigators with expertise and insights in the area of clinical Parkinson's disease research and biomarker discovery to begin to consider applying for this new Funding Opportunity Announcement (FOA). In May 2010, a Workshop was convened by the National Institute of Neurological Disorders and Stroke (NINDS) (http://www.ninds.nih.gov/research/parkinsonsweb/PD_meeting_schedule.htm) to discuss the current state of biomarker development in PD and how discovery, standardization and validation of biomarkers could most effectively facilitate therapy development in PD. Given the insights and recommendations provided at the workshop, the Parkinson's Disease Biomarkers Identification Network (PD-BIN) is being developed as part of the NINDS response to the critical need for biomarker development in PD. In September 2010, a RFA (NS-11-005; http://grants.nih.gov/grants/guide/rfa-files/RFA-NS-11-005.html) was released for linked U01s for a Clinical Coordinating Center (CCC) and Data Coordinating Center (DCC) as the initial step for the Parkinson's Disease Biomarker Identification Network (PD-BIN). The CCC under that intended award will include sites which will recruit and characterize a core cohort of de novo subjects with Parkinson's disease and control subjects to be evaluated in a longitudinal manner. That FOA did not allow for hypothesis driven research.

The purpose of this Notice is to inform potential applicants of the intention to develop an initiative that will enable hypothesis-driven studies to validate promising biomarkers that require active participation of the core cohort (these may include clinical or imaging studies). The timing of this intended FOA will be such that measures can be integrated into the longitudinal planning efforts of the CCC and DCC. All projects under the PD-BIN program are expected to fully cooperate with and utilize the core resources of the PD-BIN CCC-DCC and biorepository in order to allow full sharing and future cross sectional as well as longitudinal studies by members of the Network.

This FOA will not include other cohort studies, animal studies, assay design, or other laboratory based studies, which are expected to be solicited via different mechanisms in the future.

APPLICATIONS ARE NOT BEING SOLICITED AT THIS TIME.

Please direct all inquiries to:

Katrina Gwinn, M.D.
(National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-5745
Email: [email protected]