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METHOD OF RANDOMIZING PATIENTS IN A CLINICAL TRIAL

机译:在临床试验中随机分配患者的方法

摘要

A randomization mechanism for enabling randomization of a patient to one of two treatment options having different time-to-treatments is presented. Data is received for a patient experiencing symptoms of the type treatable by either of the two treatment options. The received data is used to compute for a first treatment option of the two treatment options at its associated time-to-treatment a benefit value. Assuming a benefit value for the second treatment option is an estimate of the computed first benefit value, the received data and computed benefit value are used to compute a maximum allowable delay time during which the benefit value for the second treatment option is no less than the benefit value computed for the first treatment option. When provided a given delay time by which the time-to-treatment of the second treatment option lags the first treatment option time-to-treatment, the mechanism determines if the given delay time is less than or equal to the allowable delay time. If the given delay time is determined to be less than or equal to the allowable delay time, then the patient is eligible for randomization.
机译:提出了一种随机化机制,用于使患者能够随机化为具有不同治疗时间的两个治疗方案之一。接收有关经历两种治疗方案中的任一种均可治疗的症状的患者的数据。所接收的数据用于在其相关的治疗时间为两个治疗选项中的第一治疗选项计算受益值。假设第二治疗方案的收益值是计算出的第一收益值的估计值,则接收到的数据和计算出的收益值用于计算最大允许延迟时间,在此期间第二治疗方案的收益值不小于为第一个治疗方案计算的收益值。当提供给定的延迟时间,第二治疗方案的治疗时间落后于第一治疗方案的治疗时间时,该机构确定给定的延迟时间是否小于或等于允许的延迟时间。如果确定给定的延迟时间小于或等于允许的延迟时间,则患者有资格进行随机分组。

著录项

  • 公开/公告号EP1225830A4

    专利类型

  • 公开/公告日2004-07-07

    原文格式PDF

  • 申请/专利权人 NEW ENGLAND MEDICAL CENTER HOSPITALS INC.;

    申请/专利号EP20000991906

  • 发明设计人 SELKER HARRY P.;

    申请日2000-10-31

  • 分类号G06F19/00;A61B5/0452;

  • 国家 EP

  • 入库时间 2022-08-21 22:55:34

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