CLINICAL TRIALS COOPERATIVE GROUP NIH GUIDE, Volume 23, Number 31, August 19, 1994 SOURCES SOUGHT ANNOUNCEMENT P.T. 34 Keywords: 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 components: 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 issues. 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 trial. 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 applications. 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 by NIDCD. 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. INQUIRIES 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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