Reissuance of NIDCR Prospective Observational or Biomarker Validation Study Cooperative Agreement

January 2023

Division of Extramural Research

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We are seeking NIDCR Council concurrence on the reissue of the funding opportunity announcement (FOA) titled “NIDCR Prospective Observational or Biomarker Validation Study Cooperative Agreement (U01 Clinical Trial Not Allowed)”. The goal of this Concept is to provide investigators with the support necessary to conduct prospective cohort studies or biomarker validation studies.

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This funding opportunity announcement (FOA) supports research that utilizes the U01 grant mechanism for up to 5 years. The first version of this FOA was published in 2017, and since then it has been consistently utilized by junior and senior investigators to request support for resource intensive studies. The FOA was first published as PAR-17-154 in February 2017 and reissued as PAR-20-060. This most recent announcement is due to expire on May 8, 2023.

Overall, a total of 29 unique applications have been received in response to this FOA series. Of those, 12 applications were awarded, 11 were not awarded, and 6 are pending (Table 1).

  • PAR-20-060: A total of 16 unique applications were submitted in 2020-2022. After excluding 6 pending applications, 5 (50%) were awarded. Of these successful applications, 2 were MPI and 1 was from a new investigator (NI).
  • PAR-17-154: A total of 13 unique applications were received in 2017-2019 and 7 (54%) were awarded. Of these, 2 were MPI, 1 was from an early-stage new investigator (ESI/NI), and 1 supported 2 supplements.
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Table 1. Grant Applications (2017-2022)*

PAR Status n
PAR-20-060 Total unique applications 16
Awarded 5
- At 1st Submission 1
- After 1st Submission 4
Not awarded 5
Pending 6
PAR-17-154 Total unique applications 13
Awarded 7
- At 1st Submission 2
- After 1st Submission 5
Not Awarded 6

*Excluding bridge awards, supplements, and non-competing renewals.

The FOA supports grant applications that propose resource-intensive prospective observational studies and/or biomarker validation studies. Awarded applications have proposed prospective (n=8) or validation (n=3) studies, or both (n=1).

A bar graph depicting the production of publications over 7 years.
A bar graph depicting the production of publications over 7 years.

Investigators have proposed highly diverse data and sample collection approaches and types. Data and sample collection has included clinical (e.g., medical, oral/craniofacial, behavioral) data, biospecimens (e.g., plasma, saliva, tissue specimens), imaging (e.g., MRI), and/or lung and oral microbiome data.

Investigators have been very productive. The research studies conducted in response to this FOAs have led to 37 publications, even though many results from these intensive 5-year longitudinal studies are still being processed. Through these publications results have been disseminated on oral microbiome and genetic findings, treatment sequelae, behavioral findings, methodologic approaches, and validation studies to improve dental, oral and craniofacial research.

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Gaps and Opportunities

This FOA will continue to support resource intensive research proposals that require long-term data and sample collection and analysis in large cohorts. The FOA provides opportunities for developing predictive tools for optimizing disease prevention and treatment. Additionally, this FOA may also be used for long-term follow-up of clinical trial participants after a preventive or therapeutic intervention, and the initial trial has ended. There is currently no clear mechanism to follow-up participants beyond close-out. The additional follow-up could be used to assess long-term adverse events, sustained effects of the intervention, or to collect additional data that could potentially create combined cohorts to uncover new knowledge. This is also a timely opportunity to leverage existing biospecimens, data and/or epidemiologic cohorts to further promote high quality data sharing, consistent with the recent implementation of the NIH Data Management and Sharing (DMS) Policy, and generation of additional multidimensional data using new analytic methods and technologies. Consistent with the new NIH policy, NIDCR anticipates robust resource sharing, including curated, reusable data that fit common data elements and represent the population affected by the condition under study. Investigators would be expected to produce and share high quality protocols, digital data and metadata aligned with FAIR and TRUST principles.

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Specific Areas of Interest

A word collage showing the specific areas of interest of this funding opportunity.
A word collage showing the specific areas of interest of this funding opportunity.

The FOA has a dual focus: prospective cohort studies and biomarker validation studies. The supported research broadly covers craniofacial diseases or conditions. Many of the awarded projects have involved large, longitudinal, multicenter studies with extensive data and specimen collection.

Investigators supported by these FOAs have analyzed and produced publications on various dental, oral, and craniofacial health topics and methods, as well as related medical conditions, including Sjӧgren’s syndrome, speech abnormalities, oral cancer, osteoradionecrosis, cystic fibrosis, dental caries, and cleft palate.

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Examples of recent publications:

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Last Reviewed
April 2024