NIDCD Research Grants for Translating Basic Research into Clinical Practice (R01 Clinical Trial Optional)
Funding Agency:
- National Institutes of Health
Background
One goal of NIH-sponsored research is to improve human health. To do so, basic scientific discoveries must be translated into practical, clinical applications. As part of its mission, NIDCD encourages the translation of basic biomedical or behavioral research discoveries in the areas of hearing, balance, smell, taste, voice, speech and language into new clinical tools, prostheses, assistive devices, behavioral therapies or interventions and medications.
Translational research requires collaborations and interactions between basic and clinical scientists. These interactions provide the platform for the bidirectional exchange of ideas and stimulate new avenues of research for both areas. Substantial advances have been made in understanding basic biomedical (e.g., cellular, molecular, genetic) and behavioral (e.g., perception, cognition, attention, motor) aspects of NIDCD scientific mission areas. After basic scientific findings have been peer-reviewed and published and connections to the clinical condition are apparent, intentional work to translate those findings into clinical practice is necessary.
Objectives
This NOFO encourages milestone-driven applications that support the translation of peer-reviewed and published basic research findings into clinical applications that improve human health in the NIDCD mission areas. Applications may focus on prevention, diagnostics, therapeutics, medical procedures, and/or behavioral modifications that overcome existing challenges and improve clinical care in the areas of hearing, balance, smell, taste, voice, speech and language. Research conducted under this NOFO is expected to include human subjects, however, in rare occasions, preclinical studies in non-human models are allowed, with prior NIDCD approval, when a subsequent clinical trial is anticipated in the near term. Applicants proposing studies with a non-human model must contact the Research/Scientific Contact listed in this NOFO at least 6 weeks prior to submission to receive NIDCD approval. The letter of NIDCD approval must be included with the application at the time of submission, or the application will be withdrawn without review. See Section IV for additional details.
Investigator-initiated low-risk clinical trials addressing the mission and research interests of NIDCD are responsive to this NOFO. NIDCD clinical trials applications determined to have higher risk must use the U01 funding mechanism through the NIDCD Cooperative Agreement for Clinical Trials in Communication Disorders (U01 - Clinical Trial Required) program announcement PAR-24-050 and subsequent reissues.
For more information on clinical trials, including how NIDCD defines low- and high-risk clinical trials, please see https://www.nidcd.nih.gov/research/clinical-studies/researchers-professionals/know-what-is-available
Collaborative translational research between basic scientists and clinicians or clinical scientists is strongly encouraged. The connection to the clinical condition must be clearly established, and the impact on the diagnosis, treatment, or prevention of a disorder of hearing, balance, voice, speech, language, taste and/or smell in human subjects should be directly addressed by the research project.
The scope of this NOFO allows for a range of activities that translate peer-reviewed and published basic research findings to practical clinical impact on the diagnosis, treatment, or prevention of deafness and other communication disorders.
Possible goals in an application may include, but are not limited to:
- Biochemical, electrophysiological, and behavioral assays to enhance diagnostic capabilities.
- Pharmacology, toxicity, and pharmacokinetic analysis for candidate therapeutics that have demonstrated potential for the treatment of communication disorders in humans.
- Preclinical research for dosage studies and toxicity when a subsequent Phase I/II clinical trial is anticipated in the near term and if the non-human studies have received NIDCD pre-approval.
- Translation of new tools and techniques for better diagnostics or therapeutics including, but not limited to, neuroprosthetic devices, drug delivery devices, neuro-electrical stimulators and recording devices.
- Translation of laboratory-based screening tests into improved ways to identify individuals at risk for a communication disorder to allow for early intervention.
- Translation of published basic research findings into new clinical applications that support precision approaches to intervention and improve prognostic efficacy.
- Implementation of discoveries from biological, psychological, social sciences and other related areas into innovative prevention, diagnosis, and treatment paradigms, including early engagement of end users (e.g., clinicians, patients).
- Modification of laboratory measures of function or laboratory treatment protocols for use in clinical settings.
This NOFO is not intended for outcomes/health services research, the extension of ongoing clinical studies, the optimization of existing clinical protocols (in the absence of new basic discovery), early-stage translational studies that seek to obtain proof of concept data, or high-risk clinical trials. Basic discovery research or projects that are addressing the underlying mechanism of a disease are not responsive to this NOFO.
Examples of applications that would not be responsive and will not be reviewed include, but are not limited to:
- Applications that do not address NIDCD's scientific mission areas.
- Projects based upon basic research that has not been published in a peer-reviewed scientific journal.
- Research in which the relevance to a clinical condition is not established.
- Research which does not state appropriate milestones to monitor progress of the project.
- Hypothesis-driven mechanistic discovery research.
- Applications that include non-human studies that are missing the NIDCD approval-to-submit letter in their application. See Other Attachment (Approval to Submit Letter) in section IV.2.
- Applications that are missing a Milestone Plan. See Other Attachment (Milestone Plan) in section IV.2.
- Projects proposing high-risk clinical trials. See https://www.nidcd.nih.gov/research/clinical-studies/researchers-professionals/know-what-is-available for NIDCD's definition of a high-risk clinical trial.
- Renewals or extensions of work previous funded in response to RFA-DC-22-001, PAR-18-533, PAR-17-184, or PAR-14-009. See Section III.
All applicants are encouraged to contact the Research/Scientific Contact listed below at least 6 weeks in advance of submission to determine if their project is well aligned with the intent of this NOFO. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.
The maximum funding per grant must be less than $500,000 direct costs per year, unless prior approval from NIDCD is obtained. Application budgets need to reflect the actual needs of the proposed project.
February 13, 2025
Kelly King, Au.D., Ph.D.
National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone: 301-402-3458
Email: kingke@nidcd.nih.gov