This Notice was RESCINDED on September 23, 2021, Please see NOT-DE-21-014 that replaces it

RESCINDED

RESCINDED - NIDCR Policy on Applications for Investigator-Initiated Clinical Trials
Notice Number:
NOT-DE-21-004

Key Dates

Release Date:

April 23, 2021 (Rescinded September 23, 2021)

Related Announcements

PAR-21-160 - NIDCR Clinical Trial Planning and Implementation Cooperative Agreement (UG3/UH3 Clinical Trial Required)

PAR-21-197 - NIDCR Behavioral and Social Intervention Clinical Trial Planning and Implementation Cooperative Agreement (UG3/UH3 Clinical Trial Required)

NOT-DE-18-014 - NIDCR Policy on Applications for Investigator-Initiated Clinical Trials RESCINDED

Issued by

National Institute of Dental and Craniofacial Research (NIDCR)

Purpose

This Notice informs potential applicants of NIDCR policies and procedures regarding grant applications for investigator-initiated clinical trials. This Notice supersedes and rescinds the policies described in NOT-DE-18-014.

A clinical trial is defined by NIH as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. The NIDCR supports investigator-initiated clinical trials through the UG3/UH3 phased, milestone-driven cooperative agreement mechanism to address dental, oral, and craniofacial diseases and conditions. This mechanism supports clinical trials planning activities during a UG3 phase, followed by implementation of clinical trials during a UH3 phase. Progression to the UH3 phase is based on an administrative review of a detailed transition request package.

The NIDCR offers separate Funding Opportunity Announcements (FOAs) for clinical trials of behavioral/social interventions and clinical trials of drugs, biologics, devices, or procedures. For either FOA, the UG3/UH3 application must be submitted as a single application. Projects funded under either FOA must be driven by well-defined milestones to be completed during the planning phase and those to be completed during the clinical trial implementation phase. Toward the completion of the UG3 planning phase, the applicant will be required to submit a detailed transition request for the UH3 clinical trial implementation phase. The UH3 transition requests will undergo administrative review by NIH staff to determine whether an award will be made for the implementation phase. Transition decisions are based on success in meeting study milestones, NIDCR program priorities, and availability of funds. Prospective applicants should note that initial funding of the UG3/UH3 cooperative agreement does not guarantee support of the UH3 clinical trial implementation phase.

PAR-21-160 NIDCR Clinical Trial Planning and Implementation Cooperative Agreement (UG3/UH3 Clinical Trial Required): Studies appropriate for this FOA are those testing diagnostic, prevention or treatment approaches to test a drug, biologic, device, or procedure for dental, oral, or craniofacial diseases or conditions, including trials for any phase of testing for a Food and Drug Administration (FDA)-regulated product. Awards made under this FOA will initially support a one-year milestone-driven UG3 planning phase, with possible transition to a UH3 clinical trial implementation phase of up to five years. The UH3 phase of the award will support the conduct of one investigator-initiated clinical trial.

The UG3 planning phase permits both operational and scientific planning activities. Operational planning activities include, at minimum, finalizing the protocol and preparing other documents to implement the clinical trial (e.g., data collection instruments, Manual of Procedures, data management plan). Allowable scientific planning activities include small-scale data collection to assess the feasibility and/or acceptability of a planned intervention and associated study procedures (e.g., acceptability of mode of intervention delivery; feasibility of proposed data collection procedures; preliminary testing of intervention training and fidelity monitoring procedures) and assessment of the subject population to determine recruitment potential for the future trial. The UG3 phase cannot be used to test for intervention safety or efficacy. If the application proposes a clinical trial with an investigational drug, biologic or device, the investigators must have submitted the appropriate investigational application to the FDA prior to the UH3 phase.

PAR-21-197 NIDCR Behavioral and Social Intervention Clinical Trial Planning and Implementation Cooperative Agreement (UG3/UH3 Clinical Trial Required): Studies appropriate for this FOA include clinical trials to develop and test behavior change interventions related to dental, oral, or craniofacial conditions. Applications for NIDCR support of clinical trials research are expected to identify research proposals using the NIH Stage Model framework, described in detail here and incorporate an experimental medicine approach. Awards made under this FOA will initially support a milestone-driven UG3 planning phase for up to 2 years, with possible transition to a UH3 clinical trial implementation phase (UH3) of up to five years.

The UG3 phase for behavioral and social intervention clinical trials will permit both scientific and operational planning activities. Scientific planning activities include small-scale data collection to assess the feasibility and/or acceptability of a planned behavioral or social intervention and associated study procedures (e.g., acceptability of study content or mode of delivery; feasibility of proposed data collection procedures; preliminary testing of intervention training and fidelity monitoring procedures). Operational planning activities include, at a minimum, development of: the final clinical protocol; the intervention manual or equivalent; the data management system and other tools for data and quality management, safety and operational oversight plans; recruitment and retention strategies; and other essential documents. The UH3 phase will support the conduct of investigator-initiated intervention research at all stages, from early mechanistic research and intervention development (e.g., Stages 0/ I) through implementation and health services research (Stages IV/V). This FOA may also support basic behavioral experimental studies with humans that are considered clinical trials based on the NIH's revised clinical trial definition (please see Clinical Trial Requirements for Grants and Contracts for guidance).

Notice NOT-DE-18-014 is rescinded.

Inquiries

Please direct all inquiries to:

Applicants are encouraged to consult with appropriate Program staff for guidance.

Inquiries concerning investigator-initiated clinical trials to test interventions other than behavioral or social interventions should be directed to:

Dena Fischer, DDS, MSD, MS
Director, Center for Clinical Research
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-4876
Email: dena.fischer@nih.gov

Inquiries concerning investigator-initiated clinical trials to test behavioral or social interventions should be directed to:

Melissa W. Riddle, PhD
Chief, Behavioral and Social Sciences Research Branch
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-451-3388
Email: riddleme@nidcr.nih.gov


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