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THREE NEW PROGRAM ANNOUNCEMENTS FOR
NIDCD CLINICAL TRIALS
The clinical trials program of the National
Institute on Deafness and Other Communication
Disorders is pleased to announce the arrival of the
new program officer and the publication of three
new clinical trial initiatives.
For 28 years Gordon B. Hughes M.D. treated
medical and surgical adult and pediatric otologic
disorders as a member of the professional staff of
the Head and Neck Institute at the Cleveland Clinic
in Ohio. He has personal experience serving on
multicenter clinical trials and on an R01 grant in
translational research of autoimmune inner ear
disease. He is co-editor of Clinical Otology,
Third Edition published in 2007 and has published
extensively in ear related diseases. His contact
information is:
Gordon B. Hughes, M.D.
Program Officer, Clinical Trials
National Institute on Deafness and Other
Communication Disorders
6120 Executive Boulevard
EPS 400C MSC 7180
Bethesda, MD 20892-7180
Phone (301) 435-4085
Fax (301) 402-6251
E-mail hughesg@nidcd.nih.gov
The NIDCD clinical trials program has been
restructured and three new program announcements
have recently been published in the NIH Guide. The
most complete information which includes the four
websites listed below and is recommended to new
investigators, can be found at:
http://www.nidcd.nih.gov/research/clinicaltrials/
NIDCD Phase I/II Preliminary Clinical Trials
in Communication Disorders (R01)
http://grants.nih.gov/grants/guide/pa-files/PAR-08-204.html
Purpose: The NIDCD is committed to identifying
effective interventions for the treatment or
prevention of communication disorders by supporting
robust, well-designed, and well-executed clinical
trials. Before a full scale Phase III Definitive
Clinical Trial (DCT) can be undertaken, earlier
stage Phase I/II Preliminary Clinical Trials (PCT)
often are required. This funding opportunity
announcement is specifically targeted towards
supporting studies that will provide the
preliminary data that are necessary to address core
scientific, design and clinical issues prior to the
conduct of the Phase III DCT. It is intended that
these PCTs will serve to optimize the design of the
eventual Phase III DCT and NOT address the
definitive question with lower power.
NIDCD Clinical Trial Planning Grant (R34)
http://grants.nih.gov/grants/guide/pa-files/PAR-08-203.html
Purpose: The NIDCD is committed to identifying
effective interventions and behavioral approaches
for the treatment or prevention of communication
disorders by supporting robust, well-designed and
well-executed Phase III Definitive Clinical Trials
(DCT). The planning grant is designed to permit
early peer review of the proposed clinical trial in
terms of its rationale, general design,
organizational structure and implementation plan.
The planning grant is used to support the
development of a detailed Manual of Procedure (MOP)
which is required for submission when applying for
a Phase III DCT and can include preliminary studies
to refine study procedures or to document
recruitment potential of clinical sites. This
Planning Grant is NOT intended to support small
Phase I/II Preliminary Clinical Trials.
NIDCD Phase III Definitive Clinical Trials in
Communication Disorders
http://grants.nih.gov/grants/guide/pa-files/PAR-08-205.html
Purpose: This funding opportunity announcement
is targeted toward supporting well-designed,
investigator-initiated Phase III Clinical Trials
(DCT) to establish safe and effective treatments or
interventions for communication disorders. A Phase
III DCT proposed under this funding opportunity
announcement should have the potential to provide a
significant impact on clinical practice or public
health policy if successful. It is expected that
applicants for a Phase III DCT already have
adequate pre-clinical and preliminary clinical data
to support the Phase III DCT. Also, information
necessary to address core design and clinical
issues prior to the conduct of the Phase III DCT
should have already been established, and a
complete, detailed Manual of Procedures (MOP)
already developed. The MOP MUST be submitted as an
appendix to the Phase III Definitive Clinical Trial
application. The NIDCD Phase I/II Preliminary
Clinical Trial (R01) and/or NIDCD Clinical Trial
Planning Grant (R34) can be used to gather this
information and prepare the MOP.
A sample MOP, courtesy of the NIDCD Sudden
Hearing Loss Treatment Trial, can be found at
http://www.nidcd.nih.gov/staticresources/research/MOP_Final.pdf
Please feel free to email or call Dr. Hughes
with any questions you may have.
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