DEVELOPMENTAL CONFERENCE--INTERNATIONAL CLINICAL TRIALS

发展会议--国际临床试验

• 批准号: 3433902
• 负责人: PHILIP RUBIN
• 金额: $ 1.5万
• 依托单位: UNIVERSITY OF ROCHESTER
• 依托单位国家: 美国
• 财政年份: 1986
• 资助国家: 美国
• 起止时间: 1986-03-01 至 1987-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3433902
• 关键词: health science research analysis /evaluation; international health /scientific organization; neoplasm /cancer radiation therapy; travel

An international liaison of radiation oncology cooperative groups is proposed to formalize a more active federation world wide of those organizations doing clinical trials in order to achieve: 1) better communications of active trials; 2) better quality assurance of radiation treatment; 3) better description of criteria for entry of patients on study (staging, diagnostic work-up, and end results reporting including late effects criteria); and 4) better leads to selected intergroup studies with either common arms (fractionation protocols) or joint protocols to accelerate patient accrual. The present proposal will permit the formal organization of an international cooperative group to achieve these aims and objectives. A conference, whose participants will represent the leadership of three major cooperative groups in Europe and the United States, will be scheduled for April, 1986, in Paris, France. Through a series of workshops and writing sessions, the conference participants will develop a research plan patterned after the one currently in effect for the Radiation Therapy Oncology Group (RTOG). They will address the priorities in protocol design as well as protocol design itself with regard to modalities and major disease sites. Of special interest will be the modalities that are providing investigations at the leading edge of cancer research such as chemical modifiers, fractionation and time/dose studies, high LET, large field studies (hemi-body irradiation), hyperthermia, isotopic immunotherapy, intraoperative procedures, and brachytherapy. The resulting research plan will provide the necessary coordination and cooperation between international cooperative groups. Upon its completion it will receive the endorsement of the conference participants prior to its debut at national meetings. This will ensure that studies evolve in a meaningful fashion. Publication of this plan will eventually be by a scientific journal such as the International Journal of Radiation Oncology, Biology and Physics. Through development of this comprehensive research plan for international trials, it is anticipated that the scientific methodology of conducting clinical trials will be extended to third world countries to utilize their unique patient resources with a high incidence of specific cancers.

放射肿瘤学合作团体的国际联络人是 提议在世界范围内正式建立一个更活跃的联邦 组织进行临床试验的目的是：1)更好地 2)更好的辐射质量保证 治疗；3)更好地描述患者进入研究的标准 (分期、诊断工作和最终结果报告，包括延迟 效果标准)；以及4)更好地引导精选的组间研究 共同武器(分馏协议)或联合协议以 加快患者收益。 本提案将允许正式组织一项 国际合作小组为实现这些目的和目标而努力。一个 会议，与会者将代表三个主要国家的领导人 在欧洲和美国的合作小组，将计划 1986年4月，法国巴黎。通过一系列的研讨会和写作 会议期间，与会者将制定一项研究计划 仿照目前有效的放射治疗模式 肿瘤学小组(RTOG)。他们将解决协议设计中的优先事项 以及关于模式和主要的协议设计本身 疾病现场。特别值得关注的将是以下几种模式 提供癌症研究前沿的研究，如 化学改性剂，分级和时间/剂量研究，高LET，大 实地研究(半身照射)、热疗、同位素 免疫治疗、术中操作和近距离放射治疗。 由此产生的研究计划将提供必要的协调和 国际合作团体之间的合作。在它建成后 它将在会议开始之前得到与会者的认可。 在全国会议上首次亮相。这将确保研究在一个 有意义的时尚。这项计划的公布最终将在 科学期刊，如《国际放射肿瘤学杂志》， 生物学和物理学。 通过为国际制定这一全面的研究计划 审判，预计进行的科学方法论 临床试验将扩展到第三世界国家，以利用他们的 独特的患者资源，具有特定癌症的高发病率。