Clinical trials management system and method
First Claim
1. A method of designing a clinical protocol, the method comprising:
- accessing a plurality of protocol meta-models using a computing device, the plurality of protocol meta-models associated with respective diseases;
selecting a protocol meta-model of the plurality of protocol meta-models using the computing device, the protocol meta-model including a set of patient eligibility criteria and a set of workflow actions which are relevant to a disease associated with the protocol meta-model, each patient eligibility criterion of the set of patient eligibility criteria including an attribute associated with the disease and a range of values for the attribute to designate whether the patient eligibility criterion is satisfied; and
generating, by the computing device, an intelligent clinical protocol database, the intelligent clinical protocol database being encoded with one or more of the set of patient eligibility criteria and a protocol schema of one or more of the set of workflow actions.
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Abstract
Protocol meta-models are made available to a protocol designer. Each protocol meta-model includes a list of preliminary patient eligibility attributes appropriate for a particular disease category. The protocol designer chooses the appropriate meta-model, and encodes the clinical trial protocol, including eligibility and patient workflow, within the selected meta-model. The resulting protocol database is stored together with databases of other protocols in a library of protocol databases. Once a patient is enrolled into a study, the protocol database indicates to a clinician what tasks are to be performed at each patient visit. These tasks can include both patient management tasks and data management tasks.
40 Citations
35 Claims
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1. A method of designing a clinical protocol, the method comprising:
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accessing a plurality of protocol meta-models using a computing device, the plurality of protocol meta-models associated with respective diseases; selecting a protocol meta-model of the plurality of protocol meta-models using the computing device, the protocol meta-model including a set of patient eligibility criteria and a set of workflow actions which are relevant to a disease associated with the protocol meta-model, each patient eligibility criterion of the set of patient eligibility criteria including an attribute associated with the disease and a range of values for the attribute to designate whether the patient eligibility criterion is satisfied; and generating, by the computing device, an intelligent clinical protocol database, the intelligent clinical protocol database being encoded with one or more of the set of patient eligibility criteria and a protocol schema of one or more of the set of workflow actions. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17)
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18. A system to design a clinical protocol, the system comprising:
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a computing device; a memory device to storing instructions that, when executed by the computing device, cause the computing device to perform operations comprising; accessing a plurality of protocol meta-models using a computing device, the plurality of protocol meta-models associated with respective diseases; selecting a protocol meta-model of the plurality of protocol meta-models using the computing device, the protocol meta-model including a set of patient eligibility criteria and a set of workflow actions which are relevant to a disease associated with the protocol meta-model, each patient eligibility criterion of the set of patient eligibility criteria including an attribute associated with the disease and a range of values for the attribute to designate whether the patient eligibility criterion is satisfied; and generating an intelligent clinical protocol database using the computing device, the intelligent clinical protocol database being encoded with one or more of the set of patient eligibility criteria and a protocol schema of one or more of the set of workflow actions. - View Dependent Claims (19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35)
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Specification