Clinical trials management system and method
First Claim
1. A method for designing a clinical protocol, the method comprising:
- creating a plurality of protocol meta-models using a computing device, each of said plurality of protocol meta-models includes at least one list relevant to a designated disease, said at least one list contains a set of patient eligibility criteria and a set of workflow actions, each of said set of patient eligibility criteria includes an attribute associated with the designated disease and an assigned range of values for said attribute to designate if that said patient eligibility criteria is satisfied;
selecting at least one protocol meta-model of said plurality of protocol meta-models using the computing device; and
generating an intelligent clinical protocol database via said computing device using an authoring tool that encodes one or more of said set of patient eligibility criteria and a protocol schema associated with the selected at least one protocol meta-model and that facilitates entry of one or more of said set of workflow actions into the intelligent clinical protocol database.
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Accused Products
Abstract
Meta-models are made available to clinical trial protocol designers. A 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 in a protocol database. The resulting protocol database is stored together with databases of other protocols in a library of protocol databases. Sponsors and individual clinical sites have controlled access to the protocols. Study sites make reference to the protocol database in order to perform patient eligibility screening. Once a patient is enrolled into a study, the protocol database indicates to the clinician what workflow tasks are to be performed at each patient visit.
43 Citations
17 Claims
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1. A method for designing a clinical protocol, the method comprising:
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creating a plurality of protocol meta-models using a computing device, each of said plurality of protocol meta-models includes at least one list relevant to a designated disease, said at least one list contains a set of patient eligibility criteria and a set of workflow actions, each of said set of patient eligibility criteria includes an attribute associated with the designated disease and an assigned range of values for said attribute to designate if that said patient eligibility criteria is satisfied; selecting at least one protocol meta-model of said plurality of protocol meta-models using the computing device; and generating an intelligent clinical protocol database via said computing device using an authoring tool that encodes one or more of said set of patient eligibility criteria and a protocol schema associated with the selected at least one protocol meta-model and that facilitates entry of one or more of said set of workflow actions into the intelligent clinical protocol database. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11)
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12. At least one non-transitory computer readable medium for collectively carrying:
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a plurality of protocol meta-models, each of said plurality of protocol meta-models includes a list relevant to a designated disease, said list contains a set of patient eligibility criteria and a set of workflow actions, each of said set of patient eligibility criteria includes an attribute associated with the designated disease and an assigned range of values for said attribute to designate if that said patient eligibility criteria is satisfied; and an authoring tool to generate an intelligent clinical protocol database, said authoring tool encoding a set of patient eligibility criteria and a protocol schema associated with a selected protocol meta-model into the intelligent clinical protocol database and facilitating entry of specific features of a clinical protocol into the intelligent clinical protocol database; wherein said intelligent clinical protocol database is generated by; selecting the protocol meta-model from said plurality of protocol meta-models, including selection of preliminary patient eligibility criteria and workflow actions; selecting values for individual attributes in said preliminary patient eligibility criteria; establishing eligibility criteria based on said values selected; and facilitating entry of a workflow based on said workflow actions selected. - View Dependent Claims (13, 14)
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15. An article comprising a machine-readable medium storing machine-readable instructions that, when applied to a machine, cause the machine to:
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create a plurality of protocol meta-models using a computing device, each of said plurality of protocol meta-models includes at least one list relevant to a designated disease, said at least one list contains a set of patient eligibility criteria and a set of workflow actions, each of said set of patient eligibility criteria includes an attribute associated with the designated disease and an assigned range of values for said attribute to designate if that said patient eligibility criteria is satisfied; select at least one protocol meta-model of said plurality of protocol meta-models from a using the computing device; and generate an intelligent clinical protocol database via said computing device using an authoring tool that encodes one or more of said set of patient eligibility criteria and a protocol schema associated with the selected at least one protocol meta-model and that facilitates entry of one or more of said set of workflow actions into the intelligent clinical protocol database. - View Dependent Claims (16, 17)
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Specification