Notice Number: NOT-DE-15-008

Key Dates
Release Date: August 28, 2014 (Rescinded April 2, 2018)

Related Announcements
PA-16-161
PA-16-160
NOT-DE-14-009
NOT-DE-11-002

Issued by
National Institute of Dental and Craniofacial Research (NIDCR)

Purpose

This Notice informs potential applicants of changes in NIDCR policies and procedures regarding acceptance and peer review of grant applications for investigator-initiated clinical trials and biomarker clinical validation studies involving prospective collection of clinical specimens.

NIDCR supports investigator-initiated clinical trials and biomarker clinical validation studies with two funding opportunities: (1) a clinical trial planning grant (R34) to support complete planning of the trial or study and (2) a clinical trial or clinical validation study cooperative agreement (U01) to support conduct of the trial or study. Both types of applications are evaluated for scientific and technical merit by an appropriate peer review group convened by the NIDCR. Investigator-initiated applications proposing clinical trials or clinical biomarker validation studies are not accepted for review by NIDCR via other funding mechanisms. Since the R34 planning grant phase for behavioral and social interventions may include pilot testing of the intervention, while pilot testing of the intervention is not allowed during the R34 phase for drug and device efficacy trials, the review criteria for these planning grants differ.

Overview of NIDCR Investigator-Initiated Clinical Trials and Biomarker Clinical Validation Studies

Clinical Trial or Biomarker Clinical Validation Study Planning (R34) Grants
NIDCR provides one year of R34 planning grant support to complete the design and documentation for investigator-initiated Phase I, II, III, and IV interventional clinical trials or biomarker clinical validation studies with prospective collection of clinical specimens. Beginning with October 2011 application receipt dates, NIDCR expanded the R34 / U01 grant program to include studies involving prospective collection of clinical specimens with clinical outcomes for the purposes of biomarker validation since they are time-consuming, labor-intensive, complex, and costly studies. This grant program does not apply to biomarker discovery research or biomarker evaluation studies utilizing previously collected and stored samples. The goal of R34 support is to establish the research team, develop tools for data management and oversight of the research, define recruitment and retention strategies, and develop and finalize the clinical protocol for the future trial or study. Other activities supported with R34 funds include the development of the Clinical Investigators Brochure for clinical trials involving investigational products, and the production of the draft study Manual of Procedures. Because clinical trials are costly and time-intensive, NIDCR strongly encourages investigators to consult with NIDCR staff prior to beginning the application process to determine NIDCR interest in the concept that would be proposed in the application. Prospective applicants should note that receipt of a Planning Grant award does not guarantee or imply funding for a subsequent clinical trial or biomarker clinical validation study cooperative agreement application.

For investigators planning behavioral or social intervention trials, the R34 Behavioral or Social Intervention Clinical Trial Planning Grant will provide support for activities that include, but are not limited to: the development of the behavioral or social intervention manual and procedures for training interventionists; development of the clinical protocol that will guide a subsequent clinical trial; the tools for data management, participant safety and operational oversight; and other activities to prepare for a subsequent clinical trial. R34 applications preparing for a behavioral or social intervention study may involve human subjects as part of testing the feasibility and acceptability of the intervention(s), measures, methods, training approaches, etc. However, the R34 planning grant is not meant to support small-scale efficacy testing of interventions.

Clinical Trial or Biomarker Clinical Validation Study Cooperative Agreement (U01)
Investigator-initiated clinical trials or clinical biomarker validation studies are only supported with the NIDCR Clinical Trial or Biomarker Clinical Validation Study Cooperative Agreement (U01). These applications must include the final draft of the study protocol, Clinical Investigators Brochure or equivalent, Quality Management plan, Data Management plan and the draft Manual of Procedures or equivalent, and meet all National Institutes of Health (NIH), Food and Drug Administration (FDA), and Office of Human Research Protections (OHRP) requirements. Investigators requesting to submit a Clinical Trial or Biomarker Clinical Validation Study Cooperative Agreement (U01) with greater than $500,000 in direct cost for any year must demonstrate they have generated a complete set of necessary documents to implement a study before the application will be accepted for peer review.

This Notice only pertains to investigator-initiated applications in response to NIDCR Program Announcements. Clinical trial or biomarker clinical validation study applications submitted in response to a Request for Applications (RFA) will follow the guidelines and instructions in the individual Funding Opportunity Announcement (FOA).

Inquiries

Inquiries concerning investigator-initiated clinical trials other than those testing behavioral or social interventions and inquiries concerning biomarker clinical validation studies should be directed to:

Jane C. Atkinson, D.D.S.
Director, Center for Clinical Research
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-435-7908
Email: jatkinso@mail.nih.gov

Inquiries concerning investigator-initiated clinical trials to test behavioral or social interventions related to NIDCR's mission should be directed to:

Melissa W. Riddle, PhD
Chief, Behavioral and Social Sciences Research Branch
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-451-3888
Email: riddleme@nidcr.nih.gov