CORE--BIOSTATISTICS

核心--生物统计学

• 批准号: 6664390
• 负责人: DAVID R SPRIGGS
• 金额: $ 18.86万
• 依托单位: SLOAN-KETTERING INST CAN RESEARCH
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-07-01 至 2003-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6664390
• 关键词: biomedical facility; cancer information system; human data; statistics /biometry

DESCRIPTION: (Applicant's Description) The Core is responsible for biostatistical design and analysis of clinical trials supported by this program project grant; to develop and maintain database containing the data of the project with a build in system to assure quality control of the data gathered. The data are maintained in the institutional clinical research database. This database allows realtime data transfer and immediate patient eligibility verification, which is a considerable asset and strength for this program. The core is organized by disease topic with assignment of statisticians to a specific disease enabling them to become thoroughly familiar with the disease entity they work in. The statisticians are intimately involved with the clinical trials, as they attend "their-disease" oriented research conferences, contributing to the initial design of the trials and design of the biostatistics section of the protocols, including sample size projection, study design and analysis. The Biostatistical Core provides state of the art statistical methods applicable to medium sized studies in which it will be possible to abandon studies early because of toxicity or lack of efficacy, to "conserve" on patients and resources, and to enhance safety. All phase II and the small number of phase III studies are well designed indicating that the core is very familiar with the literature therefore enabling them to institute novel methods early.

描述：（申请人的描述）核心负责 由此支持的临床试验的生物统计设计和分析 计划项目赠款；开发和维护包含数据的数据库 该项目具有系统的构建，以确保数据的质量控制 聚集。数据保留在机构临床研究中 数据库。该数据库允许实时数据传输和立即患者 资格验证，这是相当大的资产和力量 程序。 核心是由疾病主题组织的，将统计学家分配给 特定疾病使他们能够完全熟悉该疾病 他们工作的实体。统计学家与 临床试验，当他们参加“他们的疾病”面向研究会议时， 为试验的初始设计和设计做出贡献 协议的生物统计学部分，包括样本量投影， 研究设计和分析。 生物统计核心提供了最先进的统计方法 适用于中等大小的研究，可以放弃 由于毒性或缺乏疗效而提早研究，以“保护” 患者和资源，并提高安全性。第二阶段和小 第三阶段研究的数量经过精心设计，表明核心非常 因此，熟悉文献使他们能够制作小说 早期方法。