Reissuance of NIDCR Prospective Observational or Biomarker Validation Study Cooperative Agreement
January 2023
Division of Extramural Research
Back to topGoal
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.
Back to topBackground
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.
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).
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.
Back to topGaps 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.
Back to topSpecific Areas of Interest
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.
Back to topReferences
- https://grants.nih.gov/grants/guide/notice-files/NOT-DE-23-003.html
- https://grants.nih.gov/grants/guide/pa-files/PAR-20-060.html
- https://grants.nih.gov/grants/guide/pa-files/PAR-17-154.html
Examples of recent publications:
- Crystal YO, Keels MA, Silva MJ, Divaris K. Clinical need and scientific evidence base for a precise early childhood caries classification. Int J Paediatr Dent. 2022 Nov;32(6):773-775. doi: 10.1111/ipd.12968. Epub 2022 May 10.
- Thomson WM, Foster Page LA, Levy SM, Keels MA, Hara AT, Fontana M. Concurrent validity of the short-form Family Impact Scale (FIS-8) in 4-year-old US children. BMC Pediatr. 2022 Jul 4;22(1):391. doi: 10.1186/s12887-022-03437-5.
- Brennan MT, Treister NS, Sollecito TP, Schmidt BL, Patton LL, Lin A, Elting LS, Hodges JS, Lalla RV. Tooth Failure Post-Radiotherapy in Head and Neck Cancer: Primary Report of the Clinical Registry of Dental Outcomes in Head and Neck Cancer Patients (OraRad) Study. Int J Radiat Oncol Biol Phys. 2022 Jun 1;113(2):320-330. doi: 10.1016/j.ijrobp.2021.11.021. Epub 2021 Dec 5.
- Schrank TP, Prince AC, Sathe T, Wang X, Liu X, Alzhanov DT, Burtness B, Baldwin AS, Yarbrough WG, Issaeva N. NF-κB over-activation portends improved outcomes in HPV-associated head and neck cancer. Oncotarget. 2022 May 24;13:707-722. doi: 10.18632/oncotarget.28232. eCollection 2022.
- Lalla RV, Treister NS, Sollecito TP, Schmidt BL, Patton LL, Helgeson ES, Lin A, Rybczyk C, Dowsett R, Hegde U, Boyd TS, Duplinsky TG, Brennan MT. Radiation therapy for head and neck cancer leads to gingival recession associated with dental caries. Oral Surg Oral Med Oral Pathol Oral Radiol. 2022 May;133(5):539-546. doi: 10.1016/j.oooo.2022.01.016. Epub 2022 Jan 31.
- Maida CA, Marcus M, Xiong D, Ortega-Verdugo P, Agredano E, Huang Y, Zhou L, Lee SY, Shen J, Hays RD, Crall JJ, Liu H. Investigating Perceptions of Teachers and School Nurses on Child and Adolescent Oral Health in Los Angeles County. Int J Environ Res Public Health. 2022 Apr 14;19(8):4722. doi: 10.3390/ijerph19084722.
- Lin A, Helgeson ES, Treister NS, Schmidt BL, Patton LL, Elting LS, Lalla RV, Brennan MT, Sollecito TP. The impact of head and neck radiotherapy on salivary flow and quality of life: Results of the ORARAD study. Oral Oncol. 2022 Apr;127:105783. doi: 10.1016/j.oraloncology.2022.105783. Epub 2022 Feb 26.
- Treister NS, Brennan MT, Sollecito TP, Schmidt BL, Patton LL, Mitchell R, Haddad RI, Tishler RB, Lin A, Shadick R, Hodges JS, Lalla RV. Exposed bone in patients with head and neck cancer treated with radiation therapy: An analysis of the Observational Study of Dental Outcomes in Head and Neck Cancer Patients (OraRad). Cancer. 2022 Feb 1;128(3):487-496. doi: 10.1002/cncr.33948. Epub 2021 Oct 19.
- Mougeot JC, Beckman MF, Langdon HC, Lalla RV, Brennan MT, Bahrani Mougeot FK. Haemophilus pittmaniae and Leptotrichia spp. Constitute a Multi-Marker Signature in a Cohort of Human Papillomavirus-Positive Head and Neck Cancer Patients. Front Microbiol. 2022 Jan 18;12:794546. doi: 10.3389/fmicb.2021.794546.
- Kotlarek KJ, Sitzman TJ, Williams JL, Perry JL. Nonsedated Magnetic Resonance Imaging for Visualization of the Velopharynx in the Pediatric Population. Cleft Palate Craniofac J. 2021 Nov 17:10556656211057361. doi: 10.1177/10556656211057361.
- Warren JJ, Levy SM, Xu Y, Daly JM, Eckert GJ, Clements D, Hara AT, Jackson R, Katz BP, Keels MA, Levy BT, Fontana M. Tooth Eruption and Early Childhood Caries: A Multisite Longitudinal Study. Pediatr Dent. 2021 Jul 15;43(4):287-289.
- Chi C, Taylor KE, Quach H, Quach D, Criswell LA, Barcellos LF. Hypomethylation mediates genetic association with the major histocompatibility complex genes in Sjögren's syndrome. PLoS One. 2021 Apr 22;16(4):e0248429. doi: 10.1371/journal.pone.0248429. eCollection 2021.
December 2024