Request Information RFI): Large Scale Clinical Trials Aging Notice Number: NOT-AG-12-018 Key Dates Release Date: December 17, 2012 Response Date: September 3, 2013 Issued National Institute Aging NIA) Purpose Division Geriatrics Clinical Gerontology DGCG) the National Institute Aging NIA) supports clinical trials research topics relating aging the elderly. Researchers interest clinical trials direct costs less 2 million per year encouraged contact NIA DGCG Clinical Trials Branch staff email@example.com
. NIA DGCG also invites suggestions the scientific community regarding needs large over 2 million direct and/ over 3 million total costs per year) clinical trials research topics relevant NIA DGCG’s mission. NIA DGCG use suggestions its comprehensive planning process identify select high-priority research topics which significant current knowledge indicates need large clinical trials provide definitive information risks benefits interventions diseases conditions the elderly. Background NIA DGCG supports research health disease the aged well research aging over human life span, including relations between aging numerous health outcomes. NIA 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 changes conditions associated advancing age over human lifespan. Clinical Trials Branch plans administers clinical trials age-related changes conditions an emphasis on: Interventions prevent treat ldquo;geriatric syndromes”, disability, complications comorbidity polypharmacy; Trials detect age- comorbidity-related differences responses interventions against conditions found middle 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 http://www.nia.nih.gov/ResearchInformation/ExtramuralPrograms/Geriatrics...
Information Requested suggestions assist NIA DGCG comprehensive planning large-scale clinical trials research-topic areas relevant its mission where current evidence suggests need definitive information the benefits risks interventions diseases conditions the elderly. Please provide suggestions addressing following issues: current state science indicating need a large-scale clinical trial trials obtain definitive information the benefits and/or risks intervention interventions; Prospective study population(s) potential intervention interventions any preliminary information supporting need testing such intervention interventions a large-scale trial trials the proposed population(s). Drugs, devices, lifestyle modifications, other interventions also proposed; Rationale(s) the selection endpoints clinical, functional, surrogate). is need propose specific outcome measures; Estimate(s) sample size, duration, costs trial(s); Provide any additional comments suggestions you think be useful. Response Process Please email responses firstname.lastname@example.org
later September 3, 2013. look forward your suggestions hope will share document your colleagues. suggestions be considered part a comprehensive planning process. RFI not solicitation any comments suggestions submitted response it not create do constitute obligation upon U.S. Government, NIH, the NIA. NIA not any awards based suggestions submitted response this RFI. Furthermore, neither U.S. Government nor NIH nor NIA pay any suggestions submitted for any expenses incurred those individuals, the institutions which submitting individuals be associated, the course preparing submitting suggestions response this RFI. Finally, neither U.S. Government nor NIH nor NIA pay the of suggestions submitted response this RFI. Proprietary information, classified, confidential, otherwise sensitive information should be included responses/suggestions to/for RFI. NIA not de-identify information suggestions submitted response this RFI. U.S. Government reserves right use non-proprietary technical information any solicitation may follow. Inquiries Please direct inquiries to: Sergei V. Romashkan, M.D., Ph.D. National Institute Aging NIA) 7201 Wisconsin Ave., Ste. 525A Bethesda, MD 20892-9205 Telephone: 301-435-3047 Fax: 301-480-1066 Email: email@example.com