This patent application is assigned to
The following quote was obtained by the news editors from the background information supplied by the inventors: "Clinical trials for molecules that may become pharmaceutical products often last for years. The core cost of the trial is affected primarily by the length of the trial. And a delay of even a single day can cost hundreds or thousands and even millions of dollars.
"One of the variables most likely to affect the length of the trial has historically been patient enrollment, i.e., how quickly investigators are able to bring patients into a trial. This is due in part to the fact that a typical trial has a very limited amount of start time at the beginning and analysis time at the end. Further, the trial will require a fixed duration of treatment time in order to provide sufficient data for a submission. Because of these factors, the trials cannot be arbitrarily shortened. Further, a trial requires a certain minimum number of patients in order to prove efficacy and safety of a molecule. Thus, patient enrollment becomes the primary variable factor.
"Since the amount of time that it takes to complete patient enrollment is critical to the length of a trial, this aspect is often the focus of companies' efforts to shorten the trials. Various companies have attempted to address the need to shorten the trial. These companies include drug companies, software companies, and consulting groups.
"The conventional methods that these companies have implemented for shortening the length of a trial have focused on statistical models. A company might, for example, look at a hundred prior trials and attempt to extrapolate what would happen in a new trial based on the data culled from the earlier trial. Such models provide a relatively static view of the potential trial. Further, they often do not provide details regarding the impact of variables that go into creating the trial, such as the impact of conducting the trial in particular countries and at particular investigation sites. Thus the conventional systems lack flexibility and provide data that may or may not accurately reflect the planned trial."
In addition to the background information obtained for this patent application, NewsRx journalists also obtained the inventors' summary information for this patent application: "Embodiments of the present disclosure provide systems and methods for Predictive Analytics for Site Initiation and Patient Enrollment. In one embodiment, a three-tier system provides a client application to view and set parameters related to planning a clinical trial, a patient modeling engine for determining likely outcomes based on the parameters supplied by the user, and a database for storing historical data related to previously-completed and ongoing trials. The application in such an embodiment receives the user's parameter selections and attempts to determine in which countries and at which investigation sites the clinical trial should be conducted to meet the user's goals. The application is able to provide the user with the impact of the user's selections on the amount of time the trial is likely to take and the likely cost of the trial. The user may also be provided with best and worst case scenarios so that the user can balance risks and costs associated with a planned clinical trial.
"In one embodiment, the user is also provided with a clinical plan perspective--a view that encompasses many different molecules and clinical trials for those molecules. Such a view allows the user to determine if all the various planned clinical trials can be performed simultaneously. And if not, i.e., if saturation exits, the application allows the user to vary parameters so that the user can prioritize which trials should be done first.
"This embodiment is mentioned not to limit or define the invention, but to provide an example of an embodiment of the invention to aid understanding thereof. Embodiments are discussed in the Detailed Description, and further description of the invention is provided there. Advantages offered by the various embodiments of the present invention may be further understood by examining this specification.
BRIEF DESCRIPTION OF THE FIGURES
"These and other features, aspects, and advantages of the present disclosure are better understood when the following Detailed Description is read with reference to the accompanying drawings, wherein:
"FIG. 1 is a block diagram illustrating an exemplary environment for implementation of one embodiment of the present disclosure;
"FIG. 2 is a screen shot of a country editor view, showing color-coded countries and a popup categories table;
"FIG. 3 is a screen shot of an investigator site editor view in one such embodiment;
"FIG. 4 is a flow chart illustrating the general steps involved in one such process;
"FIG. 5 is a flowchart illustrating one method for performing tuning on an enrollment model according to one embodiment of the present disclosure;
"FIG. 6 is a flowchart illustrating method of adjusting enrollment for geographic distribution in one embodiment of the present disclosure;
"FIG. 7 is a screen shot of an enrollment country view in one embodiment of the present disclosure;
"FIG. 8 is a screenshot of a graph, illustrating the risk associated with various scenarios in one embodiment of the present disclosure;
"FIG. 9 is a screen shot of enrollment views in embodiments of the present disclosure;
"FIG. 10 is a screen shot of enrollment views in embodiments of the present disclosure; and
"FIG. 11 is a screen shot of enrollment views in embodiments of the present disclosure."
URL and more information on this patent application, see: Goodgame,
Keywords for this news article include: Machine Learning, Predictive Analytics, Emerging Technologies, Biotechnology Companies, Clinical Trials and Studies,
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