Reissuance of NIDCR Clinical Trial Planning and Implementation Grant Program

January 2021

Division of Extramural Research

Goals

Improving health through the generation of robust data from well-designed and implemented clinical trials is a high priority for the National Institute of Dental and Craniofacial Research (NIDCR). Since 2018, NIDCR has supported most of its clinical trials using a phased, milestone-driven, cooperative agreement mechanism that includes a planning phase, followed by transition to a clinical trial implementation phase if the planning phase milestones are met. The existing set of Funding Opportunity Announcements (FOAs) through which NIDCR solicits clinical trials research are expiring in May 2021. The objective of this initiative is to continue NIDCR’s clinical trials program using a similar phased, milestone-driven cooperative agreement mechanism.

Background

NIDCR is committed to identifying effective preventive, diagnostic, and treatment approaches for craniofacial, oral, and dental diseases and disorders. To advance these efforts, the Institute supports well-designed clinical trials that test interventions and have the potential to improve dental, oral and craniofacial health.

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. As described in the NIDCR Policy on Applications for Investigator-Initiated Clinical Trials, NIDCR supports most investigator-initiated clinical trials through a two-part process: (1) a planning phase followed by (2) a trial implementation phase. Because of the complexity and requirements pertaining to the conduct of clinical trials, this phased approach has ensured that planning and implementation activities meet NIDCR’s expectations. Specifically, this approach has allowed for thorough scientific and operational planning before conducting a clinical trial and evaluation of readiness to conduct the trial before implementation funds are awarded. Further, the phased mechanism has allowed for efficient transition from clinical trial planning to implementation, requiring a transition request application with administrative review rather than a new grant application between phases. The previous mechanism required a new implementation application after planning activities were completed, with delays between planning and implementation often necessitating an update to planning activities to ensure they met the current needs of communities, and that they utilized the most contemporary research methods.

NIDCR has offered 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 planning and implementation phases must be developed and described in a single grant 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. Initial funding of the planning phase cooperative agreement does not guarantee support of the clinical trial implementation phase.

The planning phase for either FOA permits both scientific and operational planning activities. 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. 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; a final statistical analysis plan; and other essential documents such as the Manual of Procedures for the subsequent clinical trial. The planning phase cannot be used to test for intervention efficacy.

Funding Opportunities

For investigator-initiated clinical trials, two FOAs have been issued using a phased, milestone-driven cooperative agreement mechanism.

NIDCR Clinical Trial Planning and Implementation Cooperative Agreement (PAR-18-547): 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. From FY2018 to FY2020, applications for 24 unique clinical trials have been submitted to this FOA.

NIDCR Behavioral and Social Intervention Clinical Trial Planning and Implementation Cooperative Agreement (PAR-18-656): 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. From FY2018 to FY2020, applications for 31 unique clinical trials have been submitted to this FOA.

NIDCR’s clinical trials program is fulfilling its goals. Both FOAs specify the requirements and expectations for NIDCR-supported trials, including the process for requesting transition from the planning phase to the implementation phase of an award. The phased award approach facilitates seamless transition from planning to implementation, allowing projects that meet planning milestones to continue with implementation of the trial without significant delays.