Notice Number: NOT-DE-08-002

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

• July 14, 2011 - See Notice NOT-DE-11-002 New NIDCR Policy: Investigator-Initiated Clinical Trials Include Biomarker Clinical Evaluation Studies.

Key Dates
Release Date: April 15, 2008

Issued by
National Institute of Dental and Craniofacial Research (NIDCR), (http://www.nidcr.nih.gov)

This notice informs potential applicants of changes in NIDCR policies and procedures for the acceptance, peer review, and funding of investigator-initiated clinical trials.

NIDCR will support investigator-initiated clinical trials exclusively through a two part grant process: (1) a clinical trial planning grant (R34) followed by (2) a clinical trial implementation cooperative agreement (U01).

Clinical trial applications in response to a Request for Applications (RFA) will follow the guidelines and instructions in the Funding Opportunity Announcement (FOA).

Clinical Trial Planning (R34) Grant

Beginning with the October 16, 2008 application receipt date for non-AIDS applications, NIDCR will support clinical trials planning grants (R34) that provide funding to complete the design and documentation for all investigator-initiated Phase I, II, III, and IV clinical trials. The R34 grant will provide up to one year of support. Pre-approval from NIDCR will be required for submission of an R34 application. Instructions for submitting a pre-approval letter will be posted on www.nidcr.nih.gov when the NIDCR Clinical Trial Planning Grant FOA is published. R34 applications will be evaluated for scientific and technical merit by an appropriate peer review group convened by NIDCR. The product of the R34 award will be an application for a clinical trial implementation cooperative agreement (U01), or the reasons for not proceeding to a clinical trial implementation application must be included in the final grant report.

The R34 grant will provide support to establish the research team, develop tools for data management and oversight of the research, define recruitment strategies, develop and finalize the clinical protocol and Clinical Investigators Brochure and all essential elements of the study required in a Manual of Procedures for the clinical trial. The Clinical Trial 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.

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, incorporating the elements developed under the planning grant. Prospective applicants should note that receipt of a Clinical Trial Planning Grant award does not guarantee or imply funding for a subsequent clinical trial implementation application.

Clinical Trial Implementation (Cooperative Agreement) Grant (U01)

The first receipt date for clinical trial implementation applications will be October 5, 2008 for non-AIDS applications. NIDCR will accept, peer review, and consider for funding applications for implementation of investigator-initiated clinical trials only from R34 awardees, unless NIDCR allows an exception. Exceptions may be given to current PAR-06-245, NIDCR Clinical Trial Planning Grant (R21) awardees. Each clinical trial implementation application (U01) will use the PHS 398 grant application with special instructions and must include the Institutional Review Board (IRB) approved study protocol, investigators brochure or equivalent, and a manual of operations 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, the peer review and award of the clinical trial implementation grant will be completed within four months of the receipt of the application.

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

• NIDCR Clinical Trial Planning Grant (R34), which will provide guidance on the submission, peer review, and award of the Clinical Trial Planning Grant; and
• NIDCR Clinical Trial Implementation Grant (U01), which will provide guidance on the submission, peer review, and award of the Clinical Trial Implementation Cooperative Agreement.

Effective immediately, the NIDCR will no longer accept applications submitted under PAR-06-245, NIDCR Clinical Trial Planning Grant (R21) http://grants.nih.gov/grants/guide/pa-files/PAR-06-245.html, or PAR-06-244, NIDCR Clinical Pilot Data Grant (R21) (http://grants.nih.gov/grants/guide/pa-files/PAR-06-244.html, or multiple investigator-initiated R01 grants for implementation of a multi-center clinical trial. Further, notices NOT-DE-03-002 (http://grants.nih.gov/grants/guide/notice-files/NOT-DE-03-002.html), NOT-DE-04-002 (http://grants.nih.gov/grants/guide/notice-files/NOT-DE-04-002.html ), and NOT-DE-04-004 (http://grants.nih.gov/grants/guide/notice-files/NOT-DE-04-004.html ) are rescinded.

Inquiries

Inquiries concerning investigator-initiated clinical trials should be directed to:
Jane C. Atkinson, D.D.S.
Program Director, Clinical Trials Program
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