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Request for Information (RFI): Large Scale Clinical Trials on Aging

Funding Number: NOT-AG-10-005
Funding Type: NOT
Release Date: April 5, 2010
Expiration Date: January 1, 2020
Web Site:
Request Information RFI): Large Scale Clinical Trials Aging Notice Number: NOT-AG-10-005 Key Dates Release Date: nbsp;April 5, 2010 Response Due Date:  September 3, 2010 Issued National Institute Aging NIA) Purpose Division Geriatrics Clinical Gerontology DGCG) the National Institute Aging NIA) supports clinical trials topics relating aging the elderly. Researchers interest trials whose direct costs less 2 million per year encouraged contact Clinical Trials Branch staff DGCG also invites suggestions the scientific community regarding needs large over 2 million direct and/ over 3 million total costs per year) clinical trials topic areas relevant DGCG’s mission. nbsp;NIA use suggestions its planning process select high priority topic areas which significant existing knowledge indicates need large clinical trials provide definitive information risks benefits interventions diseases conditions the elderly. Background DGCG supports research health disease the aged well research aging over human life span including relationships health outcomes. DGCG comprises three major research areas: Geriatrics, Clinical Gerontology, Clinical Trials. Geriatrics Branch primarily focuses health issues regarding aged. Clinical Gerontology Branch focuses clinically-related issues regarding aging changes over life span. Clinical Trials Branch plans administers clinical trials age-related issues emphasis on: Interventions prevent treat ldquo;geriatric syndromes”, disability, complications comorbidity polypharmacy Trials detect age- comorbidity-related differences responses interventions against conditions found middle age old age Interventions problems associated menopause other mid- late-life changes Interventions may affect rates progression age-related declines function early midlife Interventions protective effects against multiple age-related conditions information DGCG available INFORMATION REQUESTED suggestions assist DGCG planning large scale clinical trials topic areas relevant its mission where existing evidence suggests need definitive information the benefits risks interventions diseases conditions the elderly. Please provide suggestions addressing following issues: 1. nbsp;Provide brief description the topic area current state science indicating need a large scale clinical trial trials obtain definitive information the benefits / risks intervention interventions elderly the topic area. 2.  Define prospective study population briefly discuss potential intervention interventions any preliminary information supporting need testing such intervention interventions a large scale trial the proposed population.  Drugs, devices, lifestyle modifications, other interventions be proposed. 3.  Provide brief rationale the selection endpoints clinical, functional, surrogate). is need propose specific outcome measures. 4.  Provide estimate sample size, duration costs trial(s). 5.  Provide any additional comments suggestions you think be useful. RESPONSE PROCESS Please respond later September 3, 2010.  look forward your suggestions hope will share document your colleagues.  Inquiries respond, please send suggestions a letter, fax, email the following address: Sergei V. Romashkan, M.D., Ph.D. Chief, Clinical Trials Branch Geriatrics Clinical Gerontology Program National Institute Aging 7201 Wisconsin Avenue, Suite 525A Bethesda, MD 20892-9205 Fed Ex Packages ZIP 20814) Phone: 301-435-3047 Fax: 301-480-1066