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Clinical trial management systemRelated Patent Categories: Data Processing: Financial, Business Practice, Management, Or Cost/price Determination, Automated Electrical Financial Or Business Practice Or Management Arrangement, Health Care Management (e.g., Record Management, Icda Billing)Clinical trial management system description/claimsThe Patent Description & Claims data below is from USPTO Patent Application 20060143047, Clinical trial management system. Brief Patent Description - Full Patent Description - Patent Application Claims
[0001] This application claims the benefit of U.S. Provisional Application No. 60/153,344 filed Sep. 10, 1999. The present invention is directed to the management of clinical trials and, more particularly, to computer software applications and databases that facilitate the management of clinical trials. BACKGROUND OF THE INVENTION [0002] Before a new drug can be approved for sale to the public, governmental agencies require proof that the drug is safe for use and effective in treating some condition. To establish this, drug companies conduct tests of the drug. These tests may involve giving the drug to animals and measuring the result. However, where the drug is intended for humans, a final phase in the testing process is the conducting of clinical trials in which the drug is administered to humans and the results are measured. These tests are expensive and time consuming to design and carry out. If errors are made during the tests, the resulting data may be useless, and the test may have to be repeated, delaying the ultimate approval of the drug, resulting in lost income to the drug company, and the additional expense of repeating the tests. [0003] In order to ameliorate the potential for flawed clinical trials, various companies offer software that is intended to help manage these tests. For example, the Fraser Williams Company of Birmingham, UK, sells its Impact software for this purpose. IBM sells a program called ClinWare for the same purpose. The programs Sitebase from Parexel International Corporation of Boston, Mass.; and e.Power Clinical by Universal Systems Inc. of Chantilly, Va., all serve similar purposes. [0004] It frequently occurs that a clinical trial for a new drug will be conducted at multiple locations nationally and internationally. This helps to test the drug on diverse populations, to assess environmental differences, and to spread the burden of locating and managing a large number of people who will become the test subjects of the trial. Since laws governing clinical tests vary from country to country, the administrative management of the protocol for the trial may have to be tracked differently, yet the administrative data must be sufficiently uniform for it to be combined into total trial management results. Further, the administrative data from the different sites of the trial must be integrated in an efficient way into a single database. However, providing access to this database from around the world and by numerous users, can lead to performance degradation, e.g., slow performance and problems with access. Prior systems do not adequately address this problem. [0005] While the prior systems allow for the design of linear trials, it may be that a protocol requires split treatment, depending on the subject's response to the drug during treatment. In particular, if the early outcome is one result the treatment is governed by procedure A, and is governed by procedure B if the result is otherwise. The prior systems cannot adequately plan and track and display such complex trials. [0006] The prior systems require extensive maintenance to input information on the personnel and medications available for the clinical trial. Consequently, methods for reducing the data input requirements would be beneficial. Further, information in one trial may be the same as information in another trial, but be identified with a different name. Similarly, information given the same name can be very different. Management of this nomenclature and definition problem is particularly important in situations where there is a need to combine the planning and tracking results of several trials. [0007] The development of protocols for clinical trials is an ongoing procedure. Thus, there is a need to be able to easily modify a protocol to include new requirements. It should also be easy to tailor a global protocol to meet country and site requirements. Most prior systems lack this degree of flexibility. SUMMARY OF THE INVENTION [0008] The present invention is directed to an efficient clinical trial management system that allows for the rapid development of protocols on a hierarchical basis using templates. The templates include required tasks that can be linked to programs previously developed with the templates and can be updated as needed. Further, the system is designed to incorporate data from other databases to reduce data input requirements and to standardize definitions. [0009] In an illustrative embodiment of the invention, a clinical trial management system includes a database which is used and maintained by a software application driven by a graphical user interface. The system allows for the creation and management of a plurality of clinical trials worldwide. Other databases in an enterprise, e.g., Human Resources, are linked to the system and provide a rapid means for inputting and maintaining information in the system database. [0010] The system is modular in nature, having a variety of modules to handle different aspects of the development and management of a clinical trial. These modules include a Protocol module for establishing tracking information about a clinical trial (e.g., a protocol number) as well as the design of the administration of the protocol, e.g., the assignment of personnel to conduct the trial. [0011] The main module is a Study Planning & Tracking module which defines master and core tasks for any trial, and allows the use of templates to design the plan for the trial. This module also allows for active tracking of the trial. If the definition of master or core tasks is changed by a system administrator, this new or different task is replicated in all templates. Further, new templates can be created by modifying old ones or by entry of a completely new one. [0012] There is also a Site Management module for establishing information about a site where a trial is to be conducted (e.g., a site number, budget, etc.) and the resources at the site (e.g., personnel available at that site). A Site Contact module allows for the tracking of information received from visits to the sites where the trial is being conducted. In addition there is a Remote or Laptop module that allows information at a remote site to be entered onto a laptop computer at the remote site and later downloaded to the system. A Clinical Supplies module provides information as to the type and dosages of medications and medical devices that are available for the trial. This module also allows the system user to create shipping instructions for these materials so they will be available at the trial sites and/or allows the user to revise the trial, e.g. use different supplies, based on the materials which are available. [0013] The system also includes a Report module that generates various standard and customized reports on individual clinical trials and the entire clinical trial operation across the world. [0014] One feature of trials developed using the system is the Event Manager which automatically determines when an event in the trial has occurred that has an effect on another process in the trial. In effect this allows the completion of the last of a series of lower level tasks to trigger notification of the completion of the overall task. [0015] The system also has a significant data replication capability. In the first instance, the system is connected to other databases, such as the Human Resources and Clinical Supplies databases of the company. As employees join and leave the company, this information is naturally maintained in the company Human Resources database. The system of the present invention provides a link to this database so that when a trial is being designed, all of the available personnel can displayed for selection. This is achieved without having to input this data into the clinical trial system separately, thus saving in time, effort and expense. A similar connection is made to the Clinical Supplies database which keeps track of the drugs and medical devices available for use. As these materials are used by personnel in the company or new ones are produced, the quantity and type of inventory changes. By having a link to this database, the designer of a clinical trial can determine what products are available, and can reserve them for the trial. As necessary, links can be made to other databases to import information as needed, which eliminates the need to create and maintain other separate databases for use by the system. [0016] In a preferred configuration the system is a main file server and database at a central location, e.g., the research headquarters of a company. It is linked to subsidiary processors and databases at remote locations, e.g., in other States or countries. All of the system information is held in the main database, and subsets of that data are maintained at the remote locations. A further replication system is maintained so that an update of data at the remote or main databases will propagate to the other databases. Rules are provided to avoid conflicts. For example, the database at a remote subsidiary location will have only data related to that site and certain core information cannot be changed remotely. A change in core information at the main location automatically replicates to the necessary remote locations. The remote subsidiary locations can store some information that is not replicated to the main database, but all critical information is replicated. Also, the subsidiary locations have priority with respect to modifying particular rows of some data tables, even in the main database. [0017] Once the clinical trial has been planned, it can be displayed graphically as a Visit Map which shows the times when a patient is to visit a site to receive medication and/or be tested. This is particularly helpful when according to the plan, different courses of action are to be taken for the patient depending on interim results of the trial. BRIEF DESCRIPTION OF THE DRAWINGS [0018] The foregoing and other features of the present invention will be more readily apparent from the following detailed description and drawings of an illustrative embodiment of the invention in which: [0019] FIG. 1 is a block diagram of the hardware used to implement an embodiment of the present invention; [0020] FIG. 2 is a diagram showing the interconnection of various software modules that form parts of the system of the present invention; [0021] FIG. 3 is logical view of data in the system from the context of the subsidiaries; Continue reading about Clinical trial management system... Full patent description for Clinical trial management system Brief Patent Description - Full Patent Description - Patent Application Claims Click on the above for other options relating to this Clinical trial management system patent application. ###  How KEYWORD MONITOR works... a FREE service from FreshPatents1. Sign up (takes 30 seconds). 2. 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