NIDCR Policy on Applications for Investigator-Initiated Clinical Trials

Notice Number: NOT-DE-18-014

Key Dates
Release Date: April 2, 2018

Related Announcements
PAR-18-547
PAR-18-656
NOT-DE-15-008 RESCINDED
NOT-DE-14-009 RESCINDED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-15-008 and NOT-DE-14-009.

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-18-547 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 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 phase will permit the Program Director/Principal Investigator to finalize the study team and will support activities to develop: the final clinical protocol; the Clinical Investigator’s Brochure (or equivalent), if needed; the data management system and other data collection tools; quality management, safety and operational oversight plans; recruitment and retention strategies; a final statistical analysis plan; and other essential documents such as the Manual of Procedures for the subsequent clinical trial. The UG3 planning phase is not designed for preclinical studies with animals, the collection of preliminary data on the efficacy of the intervention (such as pilot testing), or the collection of observational data from humans to support the rationale for a clinical trial. Evaluation of the potential subject population to determine individuals’ eligibility for participation in the future UH3 trial is allowed in the UG3 phase but is not required. 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-18-656 NIDCR Behavioral and Social Intervention Clinical Trial Planning and Implementation Cooperative Agreement (UG3/UH3 Clinical Trial Required): Studies appropriate for this FOA include traditional clinical trials to develop and test behavior change interventions for preventing and treating dental, oral, or craniofacial conditions, as well as interventions used as tools to understand mechanisms of behavior change. Applications are required to identify the hypothesized targets of study interventions, and to measure target engagement as part of the study design. 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 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 data collection tools; quality management, safety and operational oversight plans; recruitment and retention strategies; and other essential documents such as the Manual of Procedures for the subsequent clinical trial. The UH3 phase of the award will support the conduct of investigator-initiated intervention research at all stages, from early mechanistic research and intervention development (e.g., Stage 0 & 1) through implementation and cost-effectiveness research (Stages IV/V).

Notices NOT-DE-15-008 and NOT-DE-14-009 are rescinded.

Inquiries

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
Acting 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