AAOHNS--CLINICAL TRIALS COOPERATIVE GROUP

AAOHNS--临床试验合作组织

• 批准号: 2900057
• 负责人: Patrick E Brookhouser
• 金额: $ 117.48万
• 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/2900057
• 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.

本申请寻求临床试验合作组的支持 致力于规划、实施、分析和传播成果 治疗或管理疾病的临床研究， 听觉、平衡、嗅觉、味觉、言语和声音或任何 组合.集团结构包括：中央办公室（CO）;中央 试验协调股（TCU）在数据管理方面经验丰富， 临床试验的统计方面;以及参与的网络 研究者组（IG）。 本申请建议美国科学院 耳鼻咽喉头颈外科基金会（AAO-HNSF）作为 鲍曼格雷医学院的一组高级研究人员 部公共卫生科学作为中央TCU，和一组高度 经验丰富，研究型耳鼻喉科医生代表20多个主要 美国公立和私立大学医疗中心 IG.耳鼻喉科临床试验合作组（OCTCG）将 与临床试验开发相关的总体职责， 选择参与单位，制定行为标准，质量 控制，并发表个人临床试验和提高 OCTCG临床试验结果的传播。一审 将研究自身免疫性内耳疾病的治疗， 潜在的破坏性条件，不治疗，可导致总 在很短的时间内造成耳聋和失衡。可用 这种情况的治疗（高剂量泼尼松甲氨蝶呤， 环磷酰胺）目前使用，没有疗效证明，或 风险评估。使用多机构，前瞻性，双重 盲法、安慰剂对照设计，研究将解决重要的 是否是一个可以接受的风险，以治疗AIED的临床问题， 强效和潜在毒性的免疫抑制药物， 无法控制疾病。 通过以下方式传播这些成果： 作战指挥协调小组应允许及时将信息直接传递给 临床实践