NIH GUIDE, Volume 23, Number 31, August 19, 1994


P.T. 34


  Clinical Trial 

  Communicative Disorders, Hearing 

National Institute on Deafness and Other Communication Disorders

The National Institute on Deafness and Other Communication Disorders

(NIDCD) is soliciting the interest of organizations that have the

capability and resources to organize a consortium, hereinafter called

Cooperative Group, of an estimated 15 to 20 Clinical Facilities with

Clinical Research Capabilities and Experience (e.g., Academic Health

Centers or Independent Research Clinics) that, as a group, would plan,

implement, conduct, analyze, and disseminate results of high priority

clinical trial research in the treatment for diseases and disorders

affecting hearing, balance, smell, taste, voice, speech, and language.

A Clinical Trial is defined as a prospective study evaluating an

experimental interaction with a control or standard, or comparing two

or more existing treatments/interventions where the outcome is likely

to contribute to change(s) in standard of care or contribute to change

in public health policy.  Many clinical trials address the efficacy of

a treatment that is already in current practice.

The Cooperative Group would, of necessity, have the following


o  Executive Policy Board and Chairperson -- to establish policy and

procedures and be representative of each participating institution and

the "grantee" organization.

o  Steering Committee of the Executive Policy Board -- to be

responsible for the development of research designs and protocols.

o  Coordinating Center -- a cooperating facility to provide statistical

support, audit, and technical services and address methodological


o  Independent Data and Safety Monitoring Committee -- to monitor the

clinical trials and assure integrity, safety, and well-being of study

subjects, informed consent, compliance, and data review.

o  Clinical Facilities with Clinical Research Capabilities and

Experience -- to provide for an adequate patient base and clinical

expertise for the conduct of diverse clinical trials in the seven areas

of NIDCD.  Not every Facility will be expected to participate in each


o  Grantee organization -- to facilitate the development, organization,

and conduct of the Cooperative Group and its required entities and be

responsible for fiscal resources and operations.

The Cooperative Group Steering Committee would initially select between

five and seven hypotheses for which clinical trial protocols would be

designed to answer high priority questions in any of the seven areas of

the NIDCD.  These protocols would involve as few or as many of the

Clinical Facilities that are necessary for the recruitment of research

subjects and to reach significant statistical power.  It is anticipated

that although most studies will be done in "series," some concomitant

studies are possible.  Each protocol will be independently peer

reviewed prior to commencement of the grant.  Interim protocols judged

of the highest program priority can be entered as supplemental


This effort is a long-term, five-year renewable commitment by NIDCD

with the grantee organization and the Cooperative Group of Clinical

Facilities.  The grantee organization will be responsible for yearly

progress reports and semiannual meetings with NIDCD staff.  During the

fourth year a comprehensive evaluation of the program will be conducted


The NIDCD would provide resources for the conduct of the clinical

trials at the Clinical Facilities, principal staff for the grantee

organization and funding for Executive Policy Board, Steering

Committee, Coordinating Units, Independent Data and Safety Monitoring

Board and other resources necessary for the successful completion of

this Cooperative Group approach to the study of clinical issues.


This Sources Sought Announcement is a request for information to assist

the NIDCD in planning for future clinical trials.  It may or may not

result in a solicitation; at this time, no funds are available for

these purposes.  Interested parties are encouraged to respond by

October 14, 1994.  Respondents are invited to discuss additional terms

or conditions with NIDCD by contacting:

Ralph F. Naunton, M.D.

Division of Communication Sciences and Disorders

National Institute on Deafness and Other Communication Disorders

Executive Plaza South, Room 400C-17

Bethesda, MD  20892-7180

Telephone:  (301) 496-1804

FAX:  (301) 402-6251


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