AAOHNS--CLINICAL TRIALS COOPERATIVE GROUP

AAOHNS--临床试验合作组织

• 批准号: 2014781
• 负责人: Patrick E Brookhouser
• 金额: $ 96.03万
• 依托单位: AMERICAN ACADEMY OF OTOLARYNGOLOGY-HEAD
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-04-15 至 2002-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2014781
• 关键词: autoimmune disorder; clinical research; cooperative study; cyclophosphamide; disease /disorder proneness /risk; dosage; drug adverse effect; ear disorder chemotherapy; human subject; human therapy evaluation; immunosuppressive; labyrinth disorder; methotrexate; outcomes research; prednisone; sensorineural hearing loss

This application seeks support for a Clinical Trials Cooperative Group dedicated to the planning, conduct, analysis, and dissemination of results of clinical studies on the treatment or management of diseases and disorders of hearing, balance, smell, taste, speech, and voice or any combination. The Group structure includes: A Central Office (CO); a Central Trials Coordination Unit (TCU) experienced in the data management and statistical aspects of clinical trials; and a network of participating Investigator Groups (IG). This application proposes the American Academy of Otolaryngology-Head and Neck Surgery Foundation, Inc. (AAO-HNSF) as the CO; a group of senior investigators at the Bowman Gray School of Medicine Dept. of Public Health Sciences as the central TCU, and a group of highly experienced, research-oriented otolaryngologists representing over 20 major public and private university medical centers in the United States as the IG. The Otolaryngology Clinical Trials Cooperative Group (OCTCG) will have overarching responsibilities related to the development of clinical trials, selection of participating units, setting standards for conduct, quality control, and publications for individual clinical trials and for enhancing the disseminatIon of results from OCTCG clinical trials. The first trial proposed will investigate treatment of autoimmune inner ear disease, a potentially devastating condition that, left untreated, can lead to total deafness and disequilibrium in a very short time period. Available treatments for this condition (high dose prednisone methotrexate, cyclophosphamide) are currently utilized without proof of efficacy or assessment of risks. Using a multi institutional, prospective, double blind, placebo controlled design, the study will address the important clinical question of whether it is an acceptable risk to treat AIED with potent and potentially toxic immunosuppressive drugs when corticosteroids fail to control the disease. The dissemination of these results through the OCTCG should allow the timely transfer of information directly to clinical practice.

此应用程序寻求对临床试验合作小组的支持 致力于规划、实施、分析和传播成果 关于疾病的治疗或管理的临床研究和 听力、平衡、嗅觉、味觉、言语和声音的障碍或任何 组合。集团结构包括：一个中央办公室(CO)；一个中央 审判协调股(TCU)在数据管理和 临床试验的统计方面；以及参与网络 调查组(IG)。这份申请书建议美国科学院 耳鼻喉科-头颈外科基金会(AAO-HNSF) 鲍曼·格雷医学院的一群高级研究员 部门公共卫生科学部作为中央TCU，以及一群高度 经验丰富、以研究为导向的耳鼻喉科医生代表了20多家主要的 美国公立和私立大学的医疗中心 IG.耳鼻喉科临床试验合作小组(OCTCG)将拥有 与临床试验发展有关的首要责任， 选择参加单位，制定行为标准，质量 对照，以及个别临床试验和增强 OCTCG临床试验结果的传播。第一次审判 提议将研究自身免疫性内耳疾病的治疗方法 如果不及时治疗，可能会导致 在很短的时间内耳聋和不平衡。可用 这种情况的治疗方法(大剂量泼尼松、甲氨蝶呤、 环磷酰胺)目前在没有疗效证明或 风险评估。使用多机构、预期、双重 盲目、安慰剂对照设计，这项研究将解决重要的 临床问题：治疗AIRD是否有可接受的风险 当皮质类固醇激素时，有效的和潜在的毒性免疫抑制药物 没能控制住疾病。通过以下途径传播这些成果 禁毒办应允许及时将信息直接传递给 临床实践。