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Apparatus and method for prediction and management of participant compliance in clinical research

机译:用于临床研究中参与者依从性的预测和管理的装置和方法

摘要

A system for developing and implementing empirically derived algorithms to generate decision rules to determine participant noncompliance and fraud with research protocols in clinical trials allows for the identification of complex patterns of variables that detect or predict participant noncompliance and fraud with research protocol, including performance and enrollment goals, in the clinical trial. The data may be used to overall predict the performance of any participant in a clinical trial, allowing selection of participants that tend to produce useful, high-quality results. The present invention can also be used to monitor participant compliance with the research protocol and goals to determine preferred actions to be performed. Optionally, the invention may provide a spectrum of noncompliance, from minor noncompliance needing only corrective feedback, to significant noncompliance requiring participant removal from the clinical trial or from future clinical trials. The algorithms and decision rules can also be domain-specific, such as detecting non-compliance or fraud among subjects in a cardiovascular drug trial, or demographically specific, such as taking into account gender, age or location, which provides for algorithms and decision rules to be optimized for the specific sample of participants being studied.
机译:一种用于开发和实施根据经验得出的算法以生成决策规则,以确定临床试验中研究方案的参与者不依从和欺诈行为的系统,可以识别复杂的变量模式,这些变量可以检测或预测研究方案中参与者的不依从和欺诈行为,包括绩效和注册目标,在临床试验中。该数据可用于总体预测临床试验中任何参与者的表现,从而允许选择倾向于产生有用的高质量结果的参与者。本发明还可以用于监视参与者对研究方案和目标的依从性,以确定要执行的优选动作。可选地,本发明可以提供一系列不合规的情况,从仅需要纠正反馈的次要不合规到需要从临床试验或将来的临床试验中删除参与者的重大不合规。算法和决策规则也可以是特定于域的,例如在心血管药物试验中检测受试者之间的不合规或欺诈行为,也可以是特定于人口统计学的,例如考虑性别,年龄或位置,从而提供算法和决策规则针对正在研究的参与者的特定样本进行优化。

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