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US National Institutes of Health – Analytical and/or Clinical Validation of a Candidate Biomarker for Pain (R61/R33 Clinical Trial Optional) – RFA-NS-18-046
Sponsor: US National Institutes of Health 		Closing Date: 27-Nov-2018
A Notice of Clarification has been issued for this FOA on 15 October 2018. The Notice can be accessed at https://grants.nih.gov/grants/guide/notice-files/NOT-NS-19-004.html and clarifies that the Research Strategy section page limit has been increased to 20 pages.
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The overarching purpose of this Funding Opportunity Announcement (FOA) is to promote the validation of strong candidate biomarkers and endpoints for pain that can be used to facilitate the development of non-opioid pain therapeutics from discovery through Phase II clinical trials. Specifically, the focus of this FOA is on advanced analytical and clinical validation of pain biomarkers, biomarker signatures, and/or endpoints using retrospective and/or prospective methods. It is assumed that: 1) a candidate biomarker has already been identified, 2) assay technology has already been developed, and 3) a working hypothesis regarding Context of Use is in place. Research supported by this FOA will ultimately demonstrate that biomarker or endpoint change is reliably correlated with variables such as clinical outcome, pathophysiologic subsets of pain, therapeutic target engagement or response to a pain therapeutic; in addition, biomarker response will demonstrate specificity to the pain condition or therapeutic as demonstrated at multiple clinical sites. The goal of this FOA is to facilitate the advancement of robust and reliable biomarkers, biomarker signatures and endpoints of pain to application in clinical trials (Phase II clinical trials and beyond) and in the spectrum of clinical practice.

This funding opportunity uses a R61/R33 Phased Innovation Award mechanism. The R61 phase will support analytical validation studies, including resolution of pre-analytic confounding variables and standardization or harmonization of assays or equipment across testing sites. The R61 phase may also support correlational studies to further define the association between the biomarker or endpoint with disease pathology, target engagement or response to an intervention. Activities supported in the R33 phase can include more extensive analytical validation across multiple sites. In addition, the R33 phase should include extensive, multi-site retrospective and/or prospective clinical studies designed to define and optimize biomarker or endpoint sensitivity and specificity consistent with the finalized Context of Use for the biomarker, biomarker signature or endpoint.

Examples of studies that are NOT responsive for this FOA
• Natural history studies aimed only at exploring disease pathophysiology, genetic or epigenetic mechanisms rather than focused on biomarker, biomarker signature or endpoint development for use in the development of non-addictive therapeutic options for the treatment of pain
• Studies on biomarkers that are not clinically relevant to pain
• Applications that propose animal studies
• Studies focused on biomarker identification and discovery for pain conditions (Please see companion FOA, RFA-NS-18-041, instead)
• Applications that solely focus on creating or maintaining patient registries
• Therapeutic target identification
• Development or clinical testing of candidate therapeutics
• Clinical intervention studies other than those necessary to validate biomarkers
• Applications that request support for infrastructure to establish new clinical trial networks are beyond the scope of this FOA

Pre-Application Consultation
Applicants are strongly encouraged to consult with NIH Scientific/Research Staff early on during the planning for an application. This early contact will provide an opportunity to discuss and clarify NIH policies and guidelines, including the scope of the project relative to the NIH mission and intent of this FOA. These discussions also provide important information and guidance on how to develop an appropriate timeline and milestone plan, which are subject to peer review under this program.

Eligibility
• Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
• Applications from Foreign Organizations: Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Funding
• Application budgets are not limited but need to reflect the actual needs of the proposed project.
• The R61 phase can be from 1-3 years and the R33 phase can be 1-4 years, with a total project duration of no more than 5 years.

Please see the Funding Opportunity Announcement for further information. Applications may be prepared and submitted via the NIH ASSIST system or Grants.gov. For complete instructions, you must refer to both the NIH Application Guide and the Funding Opportunity Announcement (FOA), noting that instructions in the FOA take precedence over the Application Guide.

Key Dates
Letter of Intent (non-mandatory) due to NIH: 28 October 2018
Applications due to UQR&I: 13 November 2018
Applications close with NIH: 27 November 2018, 5:00pm local time of applicant organisation
Future application closing dates: 7 March 2019, 25 November 2019, 12 March 2020
Expiration date of FOA: 13 March 2020

Ahead of internal review, ensure all online components on ASSIST or Grants.gov are complete. To initiate review, email your completed Funding Application Coversheet to internationalgrants@research.uq.edu.au. Interested applicants are strongly encouraged to make contact with the UQR&I international team (via internationalgrants@research.uq.edu.au) well in advance of the UQR&I internal deadline to discuss their application.
Website: http://grants.nih.gov/grants/guide/rfa-files/RFA-NS-18-046.html

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