Notice of Intent to Publish a Funding Opportunity Announcement for Data Harmonization, Curation and Secondary Analysis of Existing Clinical Datasets (R61/R33 Clinical Trial Not Allowed)

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Notice Number: NOT-NS-19-071

Key Dates

Release Date: September 16, 2019
Estimated Publication Date of Funding Opportunity Announcement: November 01, 2019
First Estimated Application Due Date: March 16, 2020
Earliest Estimated Award Date: September 16, 2020
Earliest Estimated Start Date: September 30, 2020

Related Announcements
RFA-NS-20-007

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

Purpose

The National Institute of Neurological Disorders and Stroke (NINDS) intends to promote a new initiative by publishing a Request for Applications (RFA) to solicit applications for research that will promote discovery and / or validation of scientific or clinically-relevant hypotheses from secondary analysis of existing clinical datasets and samples, sourced from two or more multi-site clinical studies (i.e., clinical trials, natural history studies, comparative effectiveness studies). Proposals within scope of this announcement include projects focused on clinical research areas that are within the NINDS mission and go beyond the scope of the individual clinical studies being included for harmonization, curation and analyses.

This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations, confirm data accessibility, and develop appropriate projects.

The RFA is expected to be published in fall 2019 with an expected application due date in spring 2020.

This RFA will utilize the R61/R33 activity code. Details of the planned RFA are provided below. The first phase (R61) is expected to support the initial harmonization and curation of the datasets and the second phase (R33) will support analyses to address the proposed research objectives. Details of the planned RFA are provided below.

Research Initiative Details

This RFA is for the secondary curation and analysis of existing datasets from two or more multi-site clinical studies datasets. Studies may include datasets from ongoing studies; however, this RFA will not support the collection of new data.

This RFA will use the R61/R33 phased mechanism to provide multi-year funding for both a harmonization and curation phase (R61) and the analyses phase (R33). Applicants should provide sufficient information demonstrating the feasibility of obtaining access to the datasets, taking into consideration data sharing policies described in the original studies, including the scope of the informed consents, and local or regional privacy regulations. In this phased mechanism, funding of the second phase (R33) will be dependent upon meeting Go/No-Go criteria at the end of the first phase. The Go/No-Go Criteria must describe clear quantitative curation standards necessary to enable the analyses in the second phase (R33).

This Notice encourages investigators to form collaborative teams that include clinical subject matter expertise, statisticians and bioinformaticians/data scientists to begin to consider applying for this new RFA. Teams must include investigators involved in the original data acquisition as part of the investigative team or as consultants. Trainees and young investigators are also highly encouraged to be included in the investigative team.

Examples of potential research topics include, but are not limited to:

• Validation of diagnostic and/or prognostic models of outcome
• Comparative effectiveness hypotheses
• Mediation analyses of biological, cultural and environmental factors that affect treatment response or course of disease
• Evaluation of biomarker validity (including clinical outcome assessments (COAs)), in new populations and/or new context of use
• Discovery or validation of multi-domain clinical and/or biological measures for diagnosis, prognosis and/or treatment response using existing genetic and biological samples along with clinical and physiological assessments
• Extended characterization or validation of natural history disease course
• Novel methods for improving patient stratification

Examples of research that this RFA will not support include:

• Studies using non-human animal models
• Studies using data from a single clinical research study
• Multiple single-site clinical research studies
• Studies of harmonization, curation, and analysis where the primary data source is Electronic Health Record (EHR) data
• Studies of harmonization, curation, and analysis where the primary data source is metadata from EHRs

To ensure maximal value of the project, applicants to this RFA will be expected to include open-source cataloging of the processes and tools used for harmonization, curation, and analysis, as well as data sharing plans that include information on any controlled-access requirements for the curated datasets. Investigators are strongly encouraged to use open-source software, analytic tools, and programming languages to promote interoperability as well as reproducibility. Investigators are encouraged to make use of existing resources, tools and training from the NIH’s BD2K Centers (https://commonfund.nih.gov/bd2k/centers), such as:

• The Center for Expanded Data Annotation and Retrieval (CEDAR) provides a computational ecosystem for development, evaluation, use, and refinement of biomedical metadata; https://more.metadatacenter.org/tools-training
• Center for Causal Discovery (CCD) develops computational methods known as causal discovery algorithms that can be used to discover causal relationships from a combination of observational data, experimental data, and prior knowledge; https://www.ccd.pitt.edu/tools/
• Big Data for Discovery Science (BDDS) provides software tools and data resources developed for the management, manipulation, and mining of large-scale biomedical data along with education and training resources; https://bd2k.ini.usc.edu/tools/.

Proposals are expected to include plans to harmonize data to available NINDS Common Data Elements (CDEs; https://www.commondataelements.ninds.nih.gov/#page=Default) for both outcome and non-outcome variables. CDISC standards (https://www.cdisc.org/) should also be incorporated where applicable.

Funding Information

Estimated Total Funding $1,500,000 in direct costs per year
Expected Number of Awards 3
Estimated Award Ceiling Applicants should propose budgets required to conduct the work proposed.
Primary CFDA Numbers TBD

Anticipated Eligible Organizations

Inquiries

Please direct all inquiries to:

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Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

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