Notice of Correction to NOT-DE-15-008 "NIDCR Policy Regarding Acceptance and Peer Review of Investigator-Initiated Clinical Trials and Biomarker Clinical Validation Studies"

Notice Number: NOT-DE-14-009

Key Dates
Release Date:   September 4, 2014

Related Announcements
NOT-DE-15-008

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

Purpose

The purpose of this Notice is to correct and provide additional information for NOT-DE-15-008 "NIDCR Policy Regarding Acceptance and Peer Review of Investigator-Initiated Clinical Trials and Biomarker Clinical Validation Studies."  The Notice is modified as follows:

Original text, second paragraph of "Purpose" section:   
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.

Revised text, second paragraph of "Purpose" section: 
Investigator-initiated applications proposing clinical trials or clinical biomarker validation studies are not accepted for review by NIDCR via NIH Parent Announcements Parent STTR [R41/R42]Parent SBIR [R43/R44], and most specific NIDCR Funding Opportunity Announcements do not allow clinical trials.

Investigators submitting applications to NIDCR in response to trans-NIH FOAs must check the individual funding announcement to determine if NIDCR will accept clinical trials through that FOA.  Those proposing clinical trials in STTR or SBIR applications should consider if the funds available through these awards can adequately support a clinical trial, especially if the trial is testing a drug under an investigational new drug (IND) application or a device with an investigational device.

Insert text, last paragraph of "Clinical trial or Biomarker Clinical Validation Study Planning (R34) Grants" section:    

While the new NIDCR R34 Planning Grant for Behavioral and Social Interventions will support pilot and feasibility testing of the intervention planned for the clinical trial, this type of testing is not allowed during the R34 phase for drug and device efficacy trials.  Therefore, separate FOAs will be issued to support the planning phase of these two types of interventional trials.

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.
Center for Clinical Research
National Institute of Dental and Craniofacial Research
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
Behavioral and Social Sciences Research Branch
National Institute of Dental and Craniofacial Research
Telephone: 301-451-3888

Email: riddleme@nidcr.nih.gov