New NIDCR Policy: Investigator-Initiated Clinical Trials Include Biomarker Clinical Evaluation Studies

Notice Number: NOT-DE-11-002

Update: The following update relating to this announcement has been issued:

Key Dates
Release Date: July 14, 2011

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

This Notice informs potential applicants of changes in NIDCR policies and procedures for the acceptance, peer review, and funding of biomarker clinical evaluation studies involving prospective collection of clinical specimens, and restates the NIDCR policy regarding acceptance and peer review of investigator-initiated clinical trials.

Since 2008, NIDCR has supported investigator-initiated clinical trials through a two part grant process: (1) a clinical trial planning grant (R34) followed by (2) a clinical trial implementation cooperative agreement (U01). Beginning with October 2011 application receipt dates, NIDCR will expand this R34 / U01 grant program to include studies involving prospective collection of clinical specimens with clinical outcomes. Support for these studies will be through the same two part process: (1) a clinical trial or biomarker clinical evaluation study planning grant (R34) followed by (2) a clinical trial or biomarker clinical evaluation study implementation cooperative agreement (U01). Biomarker clinical evaluation studies are an integral part of the biomarker and diagnostics development pathway and, similar to clinical trials, they are time-consuming, labor-intensive, complex, and costly. As such, NIDCR will consider these studies to be logistically equivalent to clinical trials and subject to the same acceptance and peer review policies as investigator-initiated clinical trials submitted for NIDCR funding.   This policy does not apply to biomarker discovery research or biomarker evaluation studies utilizing previously collected and stored samples.

This Notice only pertains to individuals submitting investigator-initiated NIDCR clinical trial or biomarker clinical evaluation study planning grant (R34) or NIDCR clinical trial or biomarker clinical evaluation study implementation cooperative agreement (U01) applications.   Clinical trial or biomarker clinical evaluation study applications in response to a Request for Applications (RFA) will follow the guidelines and instructions in the individual  Funding Opportunity Announcement (FOA).  

Clinical Trial or Biomarker Clinical Evaluation Study Planning (R34) Grant

Beginning with the October 16, 2011 R34 application receipt date, NIDCR will accept applications and support planning grants (R34) that provide funding to complete the design and documentation for all investigator-initiated Phase I, II, III, and IV interventional clinical trials or biomarker clinical evaluation studies with prospective collection of clinical specimens. The R34 grant will provide up to one year of support. Because clinical trials are costly and time-intensive, NIDCR anticipates funding only those studies of the highest priority and mission relevance. Investigators considering preparing and submitting an application are strongly encouraged 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.Guidance for that consultation will be posted at  www.nidcr.nih.gov when the NIDCR Clinical Trial or Biomarker Clinical Evaluation Study Planning Grant FOA is published.  R34 applications will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIDCR. The product of the R34 award will be an application for a clinical trial or biomarker clinical evaluation study implementation cooperative agreement (U01), or a final grant report detailing the reasons for not proceeding to such an implementation application.

The R34 grant will provide support 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.  Other activities supported with R34 funds include the development of the Clinical Investigators Brochure for clinical trials, and the production of all essential elements of the study required by the Manual of Procedures for the clinical trial or biomarker clinical evaluation study. The Planning Grant is not designed for the collection of preliminary data or the conduct of pilot studies to support the rationale for a clinical trial or a biomarker clinical evaluation study.

It is expected that receipt of an R34 grant will lead to the timely submission of an application for support of the appropriate clinical trial or biomarker clinical evaluation study, incorporating the elements developed under the planning grant. 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 evaluation study implementation application.

Clinical Trial or Biomarker Clinical Evaluation Study Implementation Cooperative Agreement (U01)

The first receipt date for NIDCR clinical trial or biomarker clinical evaluation study implementation applications (U01) will be October 5, 2011. NIDCR will accept, peer review, and consider for funding applications for implementation of investigator-initiated clinical trials or biomarker clinical evaluation studies only from R34 awardees. NIDCR may consider an exception. Each implementation application must include the final draft of the study protocol, Clinical Investigators Brochure or equivalent, and a 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. In order not to delay the initiation of the clinical trial or biomarker clinical evaluation study, the initial peer review of the implementation grant will be completed within four months of the receipt of the application by the NIDCR.

NIDCR intends to publish the following two FOAs in the near future:

  • NIDCR Clinical Trial or Biomarker Clinical Evaluation Study Planning Grant (R34), which will provide guidance on the submission, peer review, and award of the Planning Grant; and
  • NIDCR Clinical Trial or Biomarker Clinical Evaluation Study Implementation Grant (U01), which will provide guidance on the submission, peer review, and award of the Implementation Cooperative Agreement.
Further, notice NOT-DE-08-002, http://grants.nih.gov/grants/guide/notice-files/NOT-DE-08-002.html is rescinded.

Inquiries

Inquiries concerning investigator-initiated clinical trials or biomarker clinical evaluation studies should be directed to:

Jane C. Atkinson, D.D.S.
Director, Center for Clinical Research
National Institute of Dental and Craniofacial Research
6701 Democracy Blvd., Room 634
MSC 4878
Bethesda, Maryland  20892-4878
Phone: (301) 435-7908
FAX: (301) 480-8322
email: jatkinso@mail.nih.gov

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