NOT-DE-03-002: NIDCR'S NEW CLINICAL TRIALS PROGRAM

Department of Health
and Human Services (HHS)
NIH... Turning Discovery Into Health^®

NIDCR'S NEW CLINICAL TRIALS PROGRAM

RELEASE DATE:  December 9, 2002  

NOTICE:  NOT-DE-03-002 (Rescinded per Notice NOT-DE-08-002)

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

PURPOSE OF THIS NOTICE

To inform the research community that the NIDCR will focus its clinical 
trials research program on the conduct of definitive, multicenter Phase 
III clinical trials.  The new clinical trial program to be used by 
NIDCR can be viewed at http://www.nidcr.nih.gov at Information for 
Investigators under the heading Clinical Trials.  NIDCR's use of these 
new procedures is effective immediately with the publication of this 
notice.  All new submissions following the publication of this notice 
must conform to this new process.  Applications already submitted to 
NIH for NIDCR consideration will not be subject to this new process.  
Resubmission of applications (amended A1 and A2 applications) 
originally submitted under the discontinued NIDCR Clinical Trial 
Planning Grant mechanism (PAR-99-157) or the discontinued NIDCR 
Clinical Trial Pilot Grant mechanism (PAR-99-158) will not be subject 
to this new process if the principal investigator so desires.

The process for submitting a clinical trial proposal, including the 
review criteria to be used by NIDCR, is described at 
http://www.nidcr.nih.gov.

Each full Phase III clinical trial will consist of the submission of a 
minimum of two grant applications:  one from the Study Chair and one 
from the Data Coordinating Center.  The applications for clinical 
centers may be submitted as separate grant applications or as 
subcontracts to the Study Chair or Data Coordinating Center 
applications.  Given the complex nature of multicenter Phase III 
clinical trials, NIDCR encourages the use of a Data Coordinating Center 
as an integral part of the clinical trial organization.  As part of the 
Study Chairs' application, NIDCR will require the submission of a 
detailed Manual of Procedures (MOP).  See http://www.nidcr.nih.gov for 
a model MOP showing the detail required in a well-written MOP.  Another 
example of a detail MOP table of content can be found in Meinert, CL, 
Clinical Trials Design, Conduct, and Analysis, Oxford University Press, 
1986, pp. 417-419.

To assist investigators in preparing the final applications for a 
multicenter Phase III clinical trial, in preparing the MOP, and in 
finalizing the organizational structure of the clinical trial, the 
NIDCR has revised the NIDCR Clinical Trial Planning Grant to support 
this activity (see http://www.nidcr.nih.gov). 
To provide a mechanism for the collection of preliminary data that is 
necessary to support the development of definitive Phase III clinical 
trials, NIDCR has developed the NIDCR Clinical Pilot Data Grant (see 
http://www.nidcr.nih.gov)     

NIDCR will use the U01 cooperative agreement mechanism to support Phase 
III clinical trials.  Special Terms and Conditions of award will be 
associated with these awards since NIDCR staff will have substantive 
involvement in the development, conduct, and overall management of 
these clinical trials (see http://www.nidcr.nih.gov).  Clinical trial 
applications will be peer reviewed by an NIDCR special review 
committee. Criteria to be used by peer review to evaluate each 
application are described at http://www.nidcr.nih.gov.  

INQUIRIES

Inquiries are strongly encouraged.  Opportunities to clarify any issues 
or questions from potential applicants are welcome.

Direct inquiries concerning scope, requirements, and eligibility to:

Jane C. Atkinson, D.D.S.  
Program Director, Clinical Trials Program
Center for Clinical Research 
National Institute of Dental and Craniofacial Research
Building 45, Room 4AS25L
45 Center Drive, MSC 6401
Bethesda, MD 20892-6401
Telephone (301) 435-7908
E-mail:  jatkinso@mail.nih.gov
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