Automated protocol screening to qualify patients to participate in a clinical trial
First Claim
1. A method for screening subjects for participation in a controlled data sampling process, such as a clinical or medical device trial protocol, said method comprising the steps of:
- extracting protocol criteria, where such extraction provides discrete queries and value selections, where response to said answer selection are useful to determining participant eligibility;
creating means to present such extracted protocol criteria extraction to entity responsible for patient enrollment in clinical trial, such that responsive data associated with a subject may be collected; and
means to determine subject eligibility to participate in said controlled data sampling process where such determination is based on responsive data associated with said subject.
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Abstract
The invention provides a consistent, easy to use, reliable method for evaluating each potential subject against the inclusion and exclusion criteria for a controlled data collection such as a clinical trial protocol. The invention provides a method for subject evaluation according to the clinical protocol as soon as the clinical protocol has been agreed upon. The invention provides an automated system and method of applying the clinical protocol to identifying and enrolling subjects. The invention removes both error (based on incomplete understanding or misunderstanding of the protocol) and inconsistencies owing to the subjective application. Further, to the extent physician subjectivity is affecting enrollment, the inventive system and method provides a means to monitor and quantify the subjective effect introduced into the clinical trial enrollment process.
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Citations
16 Claims
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1. A method for screening subjects for participation in a controlled data sampling process, such as a clinical or medical device trial protocol, said method comprising the steps of:
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extracting protocol criteria, where such extraction provides discrete queries and value selections, where response to said answer selection are useful to determining participant eligibility; creating means to present such extracted protocol criteria extraction to entity responsible for patient enrollment in clinical trial, such that responsive data associated with a subject may be collected; and means to determine subject eligibility to participate in said controlled data sampling process where such determination is based on responsive data associated with said subject. - View Dependent Claims (2, 3, 4, 5)
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6. A system for automated collection and assessment of data in a controlled data sampling process, said system comprising:
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devices for data input, said devices networked with a least one server; server, said server capable of implementing logic supporting GUI on data input device, supporting analytic functions, including database creation, search and analysis, and hosting at least one database; storage device for storage of data; where said system enables immediate access to data sampling information, monitoring of implementation of any data sampling process changes during the course of the data sampling, and, enables high-speed high quality statistical analysis. - View Dependent Claims (7, 8, 9, 10, 11, 12, 13, 14, 15, 16)
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Specification