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    • 1. 发明申请
    • SYSTEMS FOR CLINICAL TRIALS
    • 临床试验系统
    • WO2009060191A2
    • 2009-05-14
    • PCT/GB2008/003736
    • 2008-11-05
    • WISTA LABORATORIES LTD.WISCHIK, Claude, Michel,WISCHIK, Damon, JudeSTAFF, Roger, ToddMURRAY, Alison, Dorothy
    • WISCHIK, Claude, Michel,WISCHIK, Damon, JudeSTAFF, Roger, ToddMURRAY, Alison, Dorothy
    • G06F19/00A61B5/00
    • G06Q99/00G06F19/00G16H10/20G16H50/50
    • The invention provides methods and systems for assessing the efficacy of a pharmaceutical which is putatively disease modifying of a cognitive disorder, for use in the treatment or prophylaxis of that cognitive disorder, the method comprising the steps of: (1) stratifying a subject group into at least 2 sub-groups according to a baseline indicator of likely disease progression, (2) treating members of each subject group with the pharmaceutical for a treatment time frame, (3) deriving psychometric and optionally physiological outcome measures for each treated patient group, (4) comparing the outcomes at (3) with a comparator arm of said sub-groups which is optionally a placebo or minimal efficacy comparator arm, (5) using the comparison in (4) to derive an efficacy measure for the pharmaceutical. The methods and systems of the invention address problems such as low rate of decline over the treatment time-frame of patients who have mild-disease severity at baseline and biased withdrawal, particularly in the placebo/comparator treatment arm.
    • 本发明提供了用于评估药物的功效的方法和系统,所述药物是推定的认知障碍的疾病改变,用于治疗或预防该认知障碍,所述方法包括以下步骤:(1)将受试者组分成 根据可能的疾病进展的基线指标,至少2个亚组,(2)用药物处理每个受试者群体的治疗时间框架,(3)为每个治疗的患者组导出心理测量和任选的生理学结果测量, (4)比较(3)与所述亚组的比较组比较,其可选地是安慰剂或最小功效比较组,(5)使用(4)中的比较来得出药物的功效测定。 本发明的方法和系统解决了诸如在基线时具有轻度疾病严重程度和偏倚戒断的患者的治疗时间范围内的下降率降低的问题,特别是在安慰剂/比较治疗组中。