Clinical trial management system
First Claim
1. A clinical trial management system comprising:
- a main database of information concerning prior clinical trials and resources available to conduct future clinical trials, the information concerning prior clinical trials being at least in part in the form of a protocol of (a) scheduled visits of a test subject to a treatment site, (b) measurement of prescribed physical attributes of the subject during the visits and (c) administration of at least one prescribed medical product to the subject during the visit to determine over time the subject'"'"'s response thereto, the protocol of a prior clinical trial being stored in said main database in the form of a software template;
a main processor controlling access to said main database; and
at least one user processor in communication with said main processor to negotiate access to said main database, said user processor and main processor running a program that permits the design and tracking at said user processor of a clinical trial through access by said user processor to at least one software template in said main database and modification of the template to formulate a new clinical trial.
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Accused Products
Abstract
A system for designing and monitoring clinical trials includes a main database of information concerning prior clinical trials and resources available to conduct future clinical trials. In part information in the main database is obtained through data links to other databases in the enterprise, e.g., human resources and finance databases. Some of the information in the main database concerns prior clinical trials and is, in part, in the form of a protocol of (a) scheduled visits of a test subject to a treatment site, (b) measurement of prescribed physical attributes of the subject during the visits and (c) administration of at least one prescribed medical product to the subject during the visit to determine over time the subject'"'"'s response thereto. The protocols of prior clinical trial are stored in the main database in the form of a software template. Users access the main database through their computers which run programs that permit the design and tracking at the user'"'"'s computer of a clinical trial through access to and use of the software templates. Some users may be served indirectly through subsidiary databases distributed globally. These subsidiary databases contain portions of the data in the main database that relates to the geographical regions where they are located. Data synchronization is maintained by assigning exclusive write capability to rows of the database tables to the main database and subsidiary database, respectively. Then the modified rows are periodically exchanged. The protocol is visually displayed to users as a visit map which shows the visits a subject in the clinical trial is to make to a treatment center and what is to occur at each visit. As visits are made information is added to the system so that the progress of the trial can be monitored. If the protocol is in the form of minor tasks that make up a major task, an event manager system can indicate completion of the major task based on information entered in the system about the completion of the related minor tasks. In addition to visual presentation of the protocol, the system can generate reports and issue orders to other operations, e.g., a clinical supplies group, to facilitate the conduct of the trial.
65 Citations
45 Claims
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1. A clinical trial management system comprising:
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a main database of information concerning prior clinical trials and resources available to conduct future clinical trials, the information concerning prior clinical trials being at least in part in the form of a protocol of (a) scheduled visits of a test subject to a treatment site, (b) measurement of prescribed physical attributes of the subject during the visits and (c) administration of at least one prescribed medical product to the subject during the visit to determine over time the subject'"'"'s response thereto, the protocol of a prior clinical trial being stored in said main database in the form of a software template;
a main processor controlling access to said main database; and
at least one user processor in communication with said main processor to negotiate access to said main database, said user processor and main processor running a program that permits the design and tracking at said user processor of a clinical trial through access by said user processor to at least one software template in said main database and modification of the template to formulate a new clinical trial. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17)
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18. In a hierarchical database system including a main database and main processor to govern access to it and at least one subsidiary database and subsidiary processor to govern access to it, a method of data replication to synchronize at least a portion of data in both databases, comprising the steps of:
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arranging the data in both databases as rows of data in one or more tables;
deploying some tables from the main database to the subsidiary database as read-only tables;
deploying some portions of some tables from the main database to the subsidiary database which can be modified in the subsidiary database;
tagging each row of the tables in the main database with a main or a particular subsidiary identification such that the tagged row can only be modified at the associated main or subsidiary database; and
periodically replicating modifications to data made in subsidiary databases on subsidiary tagged rows of tables to the main database, and modifications to data made in the main database on main tagged rows of tables to the subsidiary databases.
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19. A clinical trial management system comprising:
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a main database of information concerning resources available to conduct clinical trials;
a main processor controlling access to said main database;
at least one user processor in direct communication with said main processor to negotiate access to said main database, said user processor and main processor running a program that permit the design of a clinical trial in the form of a protocol of tasks to be completed and the tracking of the completion of the tasks in the protocol at said user processor;
a subsidiary database;
a subsidiary processor controlling access to said subsidiary database, said subsidiary processor being in communication with said main processor to controlling replication of a portion of the data in the main database to said subsidiary database;
at least one subsidiary user processor in communication with said subsidiary processor, said subsidiary processor and subsidiary user processor running the program so as to permit the design and tracking at said subsidiary user processor of a protocol based on data in said subsidiary database. - View Dependent Claims (20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 42, 45)
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39. A data acquisition and management systems including a main database and a main processor running a program that (i) controls access to said main database, (ii) provides a plan in the form of a series of tasks for acquisition of data including major tasks and minor tasks that make up at least some major tasks, and (iii) organize data for presentation to a user,
a data input device for inputting data according to the plan, a data display device for displaying the plan and the status of its completion, said program automatically updating the display of the plan based on data input by device such that input of data indicating the completion of a last minor task making up a major task causes said display device to indicate completion of the major task.
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43. A clinical trial management system comprising:
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a main database of information concerning resources available to conduct clinical trials;
a main processor controlling access to said main database;
at least one user processor in direct communication with said main processor to negotiate access to said main database, said user processor and main processor running a program that permits the input of information with regard to the completion of tasks forming a protocol for a clinical trial and the tracking of the completion of the tasks at said user processor, a portion of said program printing forms determined by the data in the system. - View Dependent Claims (44)
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Specification