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    • 专利摘要:
    A computer-implemented method that makes it possible to have a generic database that contains publicly accessible clinical trial data, and a client-proprietary database that contains clinical trial data that is only accessible to a specific client, the same system of unique IDs being associated with the same reports of clinical trials in both databases. The method uses a client-specific database access object to look up relevant clinical trial data in the client-proprietary database, and when the relevant clinical trial data is not available in the client-proprietary database, the method uses a plurality of generic data database access objects for retrieving relevant data from clinical trials in the generic database.
    公开号:BE1022835B1
    申请号:E2015/5814
    申请日:2015-12-11
    公开日:2016-09-16
    发明作者:Bart Naudts；REMORTEL Piet VAN
    申请人:Mdc Partners Cvba；
    IPC主号:
    专利说明:

    Computer-implemented method and system for analyzing data from clinical trials
    Technical domain
    The present invention relates to a computer-implemented method and system for analyzing clinical trial data.
    Background Art Prior to a new medical product (e.g., a pharmaceutical), new device (e.g., surgical instrument), or new procedure, being released to the public, these products, devices, or procedures are typically subjected to clinical trials. Extensive clinical trial protocols have been developed which require specific data, for example demographic data on the target audience, proposed medications, timing of events in the clinical trial, etc. Each clinical trial is further associated with other data, for example, the investigator, the site where the test is performed, the organization that covers the costs, etc. Each of these data may be associated with additional statistics, for example the number of publications by a specific researcher, or the number of patients on a specific site, the number of tests that an organization has funded etc. Consequently, large amounts of data are associated with each clinical trial.
    There are publicly accessible databases in which the relevant clinical trial data can be consulted, for example the European Register of Clinical Trials or the American Clinical Trials Database. There are companies that have developed methods to analyze these public databases. Such an analysis is carried out for various reasons, for example to reduce the costs of setting up a new clinical trial or to determine the feasibility of a proposed clinical trial. Thus, such an analysis method is disclosed in U.S. Patent No. US-20080154640. The method comprises receiving an aggregated search at an aggregation module, consulting at least two clinical trial databases, passing the consulted data to the aggregation module, aggregating the received data and generating a result based on the aggregated data.
    In WO 2009/137408 an integration method is described for integrating user-generated content into a proprietary database. The method comprises providing a database in which content generated by compilers and user-generated content is stored, providing a server cooperating with the database and a display device connected to the server, receiving user-generated content , validating the accuracy of user-generated content, detecting potential bias in user-generated content, and displaying content-generated and user-generated content on the display device.
    Explanation of the invention
    An object of the present invention is to provide a computer-implemented method and system for analyzing clinical trial data where publicly accessible clinical trial data can be efficiently combined with client-proprietary clinical trial data.
    This object is achieved in accordance with the invention with the subject matter of the independent claims.
    The term "publicly accessible clinical trial data" as used herein refers to clinical trial data that is or has been made publicly available on the Internet.
    The term "client-proprietary clinical trial data" as used herein refers to clinical trial data that is in principle only accessible to that client, although publicly available data may also exist on the same clinical trial.
    According to an aspect of the invention, a method is set forth comprising the following steps. A generic database is provided that contains publicly accessible data from clinical trials. Clinical trial data includes a variety of clinical trial reports, each report containing at least the following data fields: name of the trial, at least one investigator of the trial, at least one site of the trial, and at least one medical indication . The generic database further comprises unique IDs, in particular a system of unique IDs, associated with each clinical trial report, investigator, site, and medical indication, and mutual relationships defined between the unique IDs of the plurality of clinical trial reports, to enable searches in the generic database based on each of these unique IDs. A plurality of generic database access objects are provided, each of which loads searches based on one or more of the unique IDs in the generic database and stores the result of the search in a first memory. In other words, each generic database access object contains a version of part of the data in the generic database that is stored in memory, sorted according to one of the unique IDs or a combination of unique IDs. A plurality of client-specific database access objects are provided for a plurality of clients who have access to their own client-proprietary database, each client-specific database access object loads searches from a client-proprietary database (that of the same client) and stores the result of stores the search in a second memory, and thus creates a version of at least a part of the client-proprietary database stored in memory. Client-proprietary clinical trial reports associate the same system of unique IDs as the system of unique IDs used in the generic database. The method further comprises the steps of providing a client user interface with a plurality of pre-programmed searches, which are provided to be sent to an associated of the client-specific database access objects and contain a combination of said unique IDs; and sending at least one of said pre-programmed searches to the associated client-specific database access objects and processing the sent search by means of said client-specific database access object. Processing by means of the client-specific database access object comprises: for those unique IDs in the received search for which client-proprietary data is present in the second memory, loading relevant client-proprietary data from the second memory; for those unique IDs in the received search query for which no client-proprietary data is present in the second memory, communicating with at least one of the generic database access objects to obtain relevant publicly accessible data; compiling a search result that contains the relevant client-proprietary data and the relevant publicly available data; and sending the composite search result back to the client user interface.
    This method makes it possible to efficiently perform a search using data retrieved from a client-proprietary database as well as publicly available clinical trial data. In addition, it is possible to give different clients access to the same database system, whereby the clients can each efficiently combine their own proprietary data with publicly accessible data to generate reports, without running the risk that the proprietary data is accessible to other clients of the database system.
    The use of unique IDs for each data field, ie test report, at least one test examinations, at least one test site and at least one medical indication, makes it easier to define mutual relationships in the database system. This offers, for example, a solution for differences between languages, different spellings for the name of a person or place, different ways of describing the same medical indication, etc.
    The mutual relationships defined between the unique IDs of the multitude of clinical trial reports enable multiple relationships between different clinical trials and different data fields. For example, a specific investigator (e.g., a physician) may be associated with multiple clinical trials, meaning that this investigator may currently be involved in various clinical trials or have participated in multiple clinical trials throughout his career. Also, for example, a specific investigator may be associated with multiple sites (e.g., a hospital) and with different clinical trials for each site, meaning that this investigator works on different sites or has worked on different clinical trials. Yet another example is that a site may be associated with multiple medical indications (e.g., a disease), each of which is associated with a number of investigators, meaning that different investigators are employed at that site, each specializing in a number of illnesses.
    In a preferred embodiment of the present invention, providing a plurality of client-specific database access objects for a plurality of clients comprises the following steps. For the client-proprietary database, the same system of unique IDs is associated with the system of unique IDs used in the generic database. In other words, the proprietary data is structured in the same way as the generic data for each client-specific database access object. The client-proprietary data is compared with the public data by the client-specific database access object, and the proprietary data is stored in the second memory if it is more accurate or complete than the publicly accessible data.
    By comparing the client proprietary data with the publicly accessible, and only storing the client proprietary data in the second memory if they are more accurate or complete, the composite search result can be more accurate or complete with regard to the data for which the client has his own proprietary data . In addition, each client-specific database access object contains a version of a portion of the client-proprietary data stored in memory if it is more accurate or complete than the generic data, sorted according to one of the unique IDs or a combination of unique IDs.
    In an advantageous embodiment of the present invention, each clinical trial report further comprises at least one of the following data fields: a number of publications associated with an investigator, a personal score associated with an investigator, a therapeutic discipline associated with a medical indication, a treatment associated with an medical indication, an organization, a person associated with an organization, a location associated with an organization, a number of patients from a clinical trial, a start date of a trial, an end date of a trial, and a status of a trial. The generic database further includes additional unique IDs associated with at least one of these data fields, and additional mutual relationships defined between at least one of the unique IDs and the additional unique IDs from the plurality of clinical trial reports.
    This advantageous embodiment allows the amount of data to be much larger, allowing for a more accurate and complete analysis of clinical trial data. This embodiment makes it possible, for example, to compare different investigators based on the number of publications or personal score when planning a new clinical trial, to decide which investigator is most suitable for the clinical trial. Another example of a possible analysis is to identify which organizations have been involved in which clinical trial studies for a specific treatment, to determine which organizations will be approached when planning a new clinical trial. In addition, the start and end dates of tests offer the possibility to request only tests between specific dates, and the status of the test makes it possible to view only tests at a certain stage.
    In a further embodiment of the present invention, adding a new clinical trial report with data fields to the generic database comprises the following steps. A new unique ID is associated with the new test report, and a plurality of generic database access objects is used to look up corresponding data fields in the generic database. In other words: the test report is associated with a new unique ID, and for the other data fields a search is made in the generic database for corresponding data. The data fields of the new clinical trial report are associated with the same unique IDs if a corresponding clinical trial report data field is already present in the generic database; if not, they are associated with a new unique ID. A message is sent to each generic database access object that is provided for loading searches based on at least one unique ID associated with at least one of the data fields of the new clinical trial report, and each generic database access object that message received loads searches based on said at least one unique ID associated with said data field of the new clinical trial report and stores the result of the search in the first memory.
    This further embodiment ensures that all new publicly available clinical trial reports that are included in the generic database are also communicated to any generic database access object that may be associated with that new clinical trial report. In other words, this can ensure that the versions of a part of the generic database that are stored in memory remain up-to-date.
    In a preferred embodiment of the present invention, adding a new clinical trial report with data fields to a client-specific database includes the following steps. Associating a new unique ID with the new test report. At least one client-specific database access object is prompted to look up corresponding data fields from clinical trial reports in the client-proprietary database. The data fields of the new clinical trial report are associated with the same unique IDs if a corresponding data field of a clinical trial report is already present in the client proprietary database. If not, at least one generic database access object is used to look up corresponding data fields from clinical trial reports in the generic database. A data field of the new clinical trial report is associated with the same unique ID if a corresponding data field of a clinical trial report is already present in the generic database. The data field of the new clinical trial report is associated with a new unique ID if there are no corresponding data fields from clinical trials, neither in the generic database nor in the client-proprietary database. A message is sent to each client-specific database access object that is provided for loading searches based on at least one unique ID associated with at least one of the data fields of the new clinical trial report, and each client-specific database access object that has received said message loads searches based on said at least one unique ID associated with said data field of the new clinical trial report and stores the result of the search in the second memory.
    This preferred embodiment ensures that all new proprietary clinical trial reports that are included in the client-specific database are also communicated to each client-specific database access object that may be associated with that new clinical trial report. In addition, the method ensures that a new data field of a proprietary clinical trial report receives the same unique IDs if it is already known in the generic database or in the client proprietary database. In this way, each client-specific database access object stores the most up-to-date version of at least a portion of the client-proprietary data available in the client-proprietary database.
    In an embodiment of the present invention, modifying a data field from an existing clinical trial report in the client proprietary database or in the generic database comprises the following steps. A message is sent to each client-specific database access object or generic database access object that is provided for loading searches based on the unique ID associated with the data field of the existing clinical trial report. Each client-specific database access object or generic database access object that has received this message loads searches based on the unique ID associated with the data field of the existing clinical trial report and stores the result of the search in the second or the second first memory.
    This method ensures that in each client-specific database access object or generic database access object the most recent change of a data field of an existing clinical trial report is stored. In addition, the changes are stored in client-specific database access objects or generic database access objects, which ensures that the composite search result that is sent back to the client user interface contains the most current data available.
    In a further advantageous embodiment of the present invention, adding a new clinical trial report data field to an existing clinical trial report in the client proprietary database comprises the following steps. A client-specific database access object is used to look up corresponding data fields from clinical trial reports in the client-proprietary database. The new clinical trial report data field is associated with the same unique ID if a corresponding clinical trial report data field is already present in the client proprietary database. If not, a generic database access object is used in a next step to look up a corresponding clinical trial report in a generic database. The new clinical trial report data field is associated with the same unique ID if a corresponding clinical trial report with a corresponding data field is already present in the generic database.
    When such a corresponding data field is neither present in the generic database nor in the client-proprietary database, the new data field of the clinical trial report is associated with a new unique ID. A message is sent to each client-specific database access object that is provided for loading searches based on the unique ID associated with the new clinical trial report data field, and each client-specific database access object that has received this message, loads searches based on the unique ID associated with said data field of the new clinical trial report and stores the result of the search in the second memory.
    In this further advantageous embodiment, each new field of a clinical trial report that is added in a client-specific database is communicated to each associated client-specific database access object. As a result, each client-specific database access object contains the most up-to-date version of at least a part of the client-proprietary data stored in the memory. Therefore, each combined search result also contains the most current available data.
    According to another aspect of the invention, a system for analyzing clinical trial data is proposed combining publicly accessible clinical trial data with client-proprietary clinical trial data, this system comprising a server system with a generic database containing publicly accessible data from contains clinical trials. Clinical trial data includes a variety of clinical trial reports, each report containing at least the following data fields: test name, at least one investigator, at least one test site, and at least one medical indication. The generic database further comprises a system of unique IDs associated with each test report, investigator, site and medical indication, and mutual relationships defined between the unique IDs of the multitude of clinical trial reports, in order to search in enable the generic database on the basis of each of these unique IDs. The system further comprises a plurality of generic database access objects on said server system, each of which is provided for loading searches based on at least one of the unique IDs in the generic database and storing the result of the search in a first memory, a plurality of client-specific database access objects on said server system for a plurality of clients, each of which is provided for loading searches from a client-proprietary database and storing the result of the search in a second memory. Each client-proprietary database contains client-proprietary data from clinical trials, and the client-proprietary data stored in the second memory is associated with the same system of unique IDs as the system of unique IDs used in the generic database. A client user interface is provided with a plurality of pre-programmed searches, which are provided to be sent to an associated of the client-specific database access objects and contain a combination of said unique IDs, and a communication means in said client user interface provided for the sending at least one of said pre-programmed searches to the associated client-specific database access objects via a communication network. The client-specific database access object is further provided with an algorithm that, when executed on said client-specific database object, processes said transmitted search by: retrieving relevant client-proprietary data from the second memory for those unique IDs in the received search for which client-proprietary data is present are in the second memory; to communicate with at least one of the generic database access objects to obtain relevant publicly accessible data for those unique IDs in the received search query for which no client-proprietary data is present in the second memory; compile a search result that contains the relevant client-proprietary data and the relevant publicly available data; and send the composite search result back to the client user interface.
    This system makes it possible to efficiently perform a search using data retrieved from a client proprietary database as well as publicly available clinical trial data. In addition, it is possible to give different clients access to the same database system, whereby the clients can each efficiently combine their own proprietary data with publicly accessible data to generate reports, without running the risk that the proprietary data is accessible to other clients of the database system. Furthermore, this system makes it possible to store the client-proprietary databases on a server other than the generic database, but on the same server system. This further reduces the risk that client-proprietary data becomes accessible to other clients. Furthermore, it is possible to store each client-proprietary database on a different server in the same server system, to prevent that client-proprietary data from different clients is confused.
    Brief description of the illustrations
    The invention will be further elucidated with the aid of the following description and the enclosed figures.
    Figure 1 shows an overview of the method according to the present invention.
    Figure 2 shows an overview of the system according to the present invention.
    Figure 3 shows an example of a clinical trial report.
    Figure 4 shows an example of mutual relationships between unique IDs associated with clinical trial reports.
    Figure 5 is a flowchart of the processing of a search query.
    Figure 6 is a flowchart of adding a new clinical trial report to a client proprietary database.
    Figure 7 is a flow chart of adding a new data field to an existing clinical trial report in a client-proprietary database.
    Embodiments of the invention
    The present invention will be described with reference to specific embodiments and with reference to certain illustrations; however, it is not limited to that, but is only determined by the conclusions. The illustrations described are only schematic and non-limiting. In the illustrations, the size of some elements for illustrative purposes may be magnified and not drawn to scale. The dimensions and relative dimensions do not necessarily correspond to actual practical embodiments of the invention.
    Furthermore, the terms first, second, third, and the like, in the description and claims, are used to distinguish between similar elements, and not necessarily to describe a sequential or chronological order. The terms are interchangeable under appropriate circumstances, and the embodiments of the invention may function in sequences other than described or illustrated herein.
    Furthermore, the terms upper, lower, top, bottom, and the like, in the description and the claims, are used for descriptive purposes, and not necessarily to describe relative positions. The terms thus used are interchangeable under appropriate circumstances, and the embodiments of the invention described herein may function in other orientations than described or illustrated herein.
    Furthermore, the various embodiments, even though they are labeled as "preferred," are to be construed as examples of ways in which the invention may be practiced, and not as limiting the scope of the invention.
    The term "comprising", used in the claims, should not be interpreted as being limited to the means listed thereafter; it does not exclude other elements or steps. The term is to be interpreted in the sense that it specifies the presence of said properties, numbers, steps or components as indicated, but does not exclude the presence or addition of one or more other properties, numbers, steps or components, or groups thereof from. The scope of the expression "a device comprising A and B" should therefore not be limited to devices that consist solely of components A and B; with regard to the present invention, the only explicitly stated components of the device are A and B, and the claim is further to be interpreted in that it comprises equivalents of those components.
    Figure 1 shows an overview of the method according to the present invention. The method provides a generic database 2 that contains publicly accessible clinical trial data. These clinical trial data are available in different registers, such as, for example, the European clinical trial register, the US clinical trial database, the WHO register, the ISRCTN register, the NTR, etc. The clinical trial data include a multitude of clinical trial reports 3 each containing at least four data fields 4, namely a test name 5, a researcher 6 (e.g., a doctor), a site 7 (e.g., a hospital), and a medical indication 8 (e.g., some symptoms or a number of inclusion / exclusion criteria).
    Figure 3 shows an example of a clinical trial report 3. The clinical trial report 3 has a trial name 5 (e.g. EudraCT Number 2010-023457-11); four researchers 6, where there can be two main researchers and two (additional) researchers; two sites 7 with the location 17 associated with that site, where there can be one principal investigator 6 and one (additional) investigator 6 per site 7; a medical indication 8, including a therapeutic discipline 9 (e.g., oncology), a disease 10 (e.g., breast cancer) and two inclusion / exclusion criteria 11 (e.g., specific biomarkers of a tumor); a treatment 12 (e.g., a specific drug); an organization 13 (e.g., a company) that finances the clinical trial, and that has a location 18; a start date 14 and an end date 15; a status 16, indicating the current phase of the clinical trial; and a number of patients from the clinical trial. The clinical trial report 3 may further include other data, such as a person 19 associated with a site or an organization; a number of publications 24 associated with a specific clinical trial; and numerous other possible data fields that are relevant to a clinical trial.
    Furthermore, it is also possible that a data field associated with a clinical trial is not released (for example, a non-released investigator or a non-released number of patients from a clinical trial).
    The generic database 2 shown in Figure 1 further comprises unique IDs associated at least with each test report 3, each researcher 6, each site 7 and each medical indication 8. The generic database 2 may further include additional unique IDs for a number of data fields in a clinical trial report 3. The generic database 2 further comprises mutual relationships defined between the unique IDs of the plurality of clinical trial reports 3, for searching in the generic database 2 based on each of these unique IDs possible.
    Figure 4 shows a possible group of mutual relationships between unique IDs in a generic database 2. A specific clinical trial report 3 has a mutual relationship with a therapeutic discipline 9, a medical indication 8, a treatment 12, a site 7, a researcher 6 and a number of publications 24. In addition, there are mutual relationships for a researcher 6 who is a person 19 with a personal score 25 and a number of publications 24, and who works on a site 7 with a location 17, and is the author 26 of a number of publications 24 Moreover, a person 19 can have a mutual relationship with an organization 13 that has a location 18 (for example the address of the head office), while the person 19 has a different location (for example his home address). There may also be several mutual relationships associated with the same system of unique IDs for different clinical trial reports 3. For example, a person 19 may be a researcher 6 associated with different sites 7 for different clinical trial reports 3. Or an organization 13 may associated with different sites 18 for different clinical trial reports 3, and the organization 13 can also be a site 7 for different clinical trial reports 3 and a financial sponsor for other clinical trial reports 3.
    Figure 1 further shows two generic database access objects 28 each loading searches based on one or more of the unique IDs in the generic database 2. There may be, for example, a generic database access object 28 that loads a search to load a list making all clinical trial reports 3 in the generic database 2. Another example is a generic database access object 28 that loads a search of all researchers 6 associated with a site 7, or a generic database access object 28 that load a search from all sites 7 of which there is a clinical trial report 3 associated with a particular disease 10. each generic database access object 28 stores the result of the search in a first memory 29 and thus contains a version of the memory part of the clinical trial data in the generic database 2, sorted according to one of the unique IDs or a combination of unique IDs.
    The method also provides a client-proprietary database 30 as seen in Figure 1, which contains client-proprietary data from clinical trials that are only accessible to the client in question. The client-proprietary data from clinical trials are associated with the same system of unique IDs as the data from clinical trials in the generic database 2. In this sense, Figure 4 shows a possible group of mutual relationships between unique IDs in the client-proprietary database 30. Figure 1 shows two different client-proprietary databases 30, each associated with a specific client. Figure 1 further shows a plurality of client-specific database access objects 31 provided for a plurality of clients who have access to their own client-proprietary database. The client-specific database access object 31 loads searches from a client-proprietary database 30 and stores them in a second memory 32. As such, each client-specific database access object 31 contains a version of at least a portion of the client-proprietary database 30 stored in memory. The clinical trial reports 3 in the client-proprietary database 30 may contain more accurate or complete information than the publicly available clinical trial reports 3 for the same trials in the generic database 2. It is also possible to compare the client-proprietary data with the publicly accessible data by means of a comparison algorithm.
    Figure 1 also shows two client user interfaces 33. Each client user interface 33 is associated with a specific client and further associated with a plurality of client-specific database access objects 31. Furthermore, each client-specific database access object 31 only has access to one client-proprietary database 30, to ensure that client-proprietary data remains inaccessible to others clients. Each client user interface 33 has a plurality of predetermined searches, and the client can also use the client user interface 33 to form a search 35 by combining a number of said predetermined searches. The client user interface 33 places each search query 35 in a predetermined format for transmission, which is selected so that the search can be processed in the client-specific database access object upon receipt. This format is preferably an independent format, although it can be interpreted in different ways in different client user interfaces and / or client-specific database access objects. Moreover, the independent notation format can be human-readable (for example, an xml or txt format) so that searches can easily be checked by people. The same format can be used for the search result 36 that is sent back to the client user interface 33.
    An example of a search 35 may be which sites 7 have been the location for a clinical trial for a specific disease 10, and which researchers 6 at those sites 7 were responsible. A possible approach to this search 35 is to first look up a list of all clinical trial reports 3 associated with a disease 8, through one client-specific database access object 31. Once the list of clinical trial reports 3 is available, other client-specific database access objects 31 can be used to look up the sites 7 and the investigators 6 associated with each clinical trial report 3. In this approach, the search query 35 is sent to one client-specific database access object 31. which then contacts other client-specific database access objects 31 to perform the search 35. Another possible approach to this search 35 is to call up two client-specific databases. access objects 31. one of which loads all researchers 6 associated with a disease 10 and the other loads all sites 7 associated with a disease 10. These two lists can then be combined to find all sites 7 with their researchers 6. A search query 35 can thus be sent by the client user interface 33 to one client-specific database access object 31 or to a plurality of client-specific database access objects 31.
    Another example of a possible search 35 is determining how many patients have participated in a clinical trial regarding a specific disease 10. This information can be very useful for determining the potential sites 7 for a proposed clinical trial. Since for each site 7 it is known how many possible patients are available per year (for example, based on the number of people living in the area around the site 7), and for every disease 10 a statistic is known that indicates how many people, for example per 100,000 people. If a proposed clinical trial requires at least 20 patients who are willing to participate, and the disease statistics 10 indicate that a possible site 7 is likely to have only 20 people with that specific disease 10, the grade of participation in previous clinical trials determine whether the possible site 7 will have enough participants.
    Figure 5 shows a flowchart showing how a search query 35 is processed according to the method 100. As explained above, a search query 35 is generated 101 at a client user interface 33, by activating a pre-programmed search query or by building a search based on a combination of pre-programmed searches. The search query 35 is then sent 102 to at least one associated client-specific-database access object 31 through a communication network 39. The number of activated client-specific-database access objects 31 depends on the number of pre-programmed searches that is in the search 35 recorded, each client-specific database access object 31 that has received said search 35, checks whether relevant data is available 103 in the second memory 32, and, if relevant data is available, loads that data in 104. If there is for one or more client-specific database access objects 31 no relevant data is available in the second memory 32, the search query 35, or a part thereof, is passed 105 to a generic database access object 28 which loads data 106 from the first memory 29 A search result 36 is then composed 107 based on of data from the first memory 28, the second memory 33 or a combination of data from the first 28 and the second memory 33. The search result 36 is then sent back to the client user interface 33 108.
    The addition of a new clinical trial 3 with associated data fields 4 to a client-proprietary database 30 takes place according to the method 200 shown in Figure 6. First, a new unique ID is associated 201 with the new test report 3. This unique ID may, for example, be the name of the test 5 registered in one of the publicly accessible clinical trial registers, these names being unique per register. For example, the trial report 3 of a new clinical unknown in the generic database can be linked to a unique ID based on a combination of the client's name and a numerical value. If the clinical trial becomes publicly accessible at a later stage, the unique ID of the trial report 3 in the client-proprietary database 30 can be changed to match the unique ID in the generic database. In a second step, at least one client-specific database access object 31 is prompted to look up corresponding data fields of clinical trial reports 4 in the client-proprietary database 30. If such corresponding data fields 4 are found, the data fields of the new clinical trial report 4 are found. associated with the same system of unique IDs. In a third step, a plurality of generic database access objects 28 are used to check the first memory 29 for searching unique IDs corresponding to data fields 4 in the new clinical trial report 3. If such corresponding data fields 4 are found by a number of generic database access objects 28, the data fields 4 of the new clinical trial report are associated 205 with the same system of unique IDs. If no corresponding data fields 4 are found in the generic database 2 or the client-proprietary database 30, a new unique ID is associated 204 with said data field of the new clinical trial report 4. In a fourth step, a message 38 is sent 206 to client-specific database access objects 31, which are activated to store a new search 207 in the second memory 32.
    Adding a new clinical trial report 3 to the generic database 2 is done with a similar method to adding a new clinical trial report 3 to a client-proprietary database 30. The main difference is that no client-specific database access objects 31 are activated, but only generi -the database access objects 28 are activated. For example, a researcher 6 of the new clinical trial report 3 may already be known in other clinical trial reports 3, and should therefore be associated with the same system of unique IDs. On the other hand, the site 7 of a clinical trial report 3 may be unknown in the other clinical trial reports 7, in which case it should be associated with a new unique ID. When each data field 4 of the new clinical trial report 3 is associated with a unique ID, a message 38 is sent to each generic database access object 28 associated with one of said unique IDs 28. The message 38 activates each generic database access object 28 for storing a new search in said first memory 29.
    To determine whether a clinical trial report 3 to be added to a client-proprietary database 30 or a generic database 2 is indeed new (ie not yet present in both databases), the name 5 of the trial of the clinical trial report 3 to be added are checked for existing names 5 of trials in the relevant database, ie the client-proprietary database 30 or the generic database 2. This can lead to the inclusion of a new clinical trial report 3 that has a different trial name 5 but is in fact the same as a clinical trial report 3 that is already known in the relevant generic 2 or client-proprietary database 30. At certain times, a comparison algorithm can be performed that compares clinical trial reports 3 in the relevant database 2, 30 to determine whether two or more clinical trial reports 5 may be identical and to remove duplicate records o f merge.
    A part of Figure 6 also shows how changing an existing data field 4 into a client-proprietary database 30 or a generic database 2 can be addressed. Since it is known which unique ID is associated with said data field 4 being changed, a message 38 is sent 206 to each client-specific database access object 31 or to each generic database access object 28 which is provided for loading searches based on the unique ID associated with the data field of the existing clinical trial report 4 being modified, each client-specific database access object 31 or generic database access object 28 that has received said message 38 is prompted to load searches based on 207 the unique ID associated with the data field of the existing clinical trial report 4 being changed, and to store the result of the search in the second 32 or the first memory 29. Depending on the database, ie the generic 2 or the client proprietary database 30, the changes are made weekly or immediately for a bit. That is, changes in client-proprietary databases 30 can be immediately passed on to associated client-specific database access objects 31, depending on when the client provides new clinical trial data. On the other hand, changes in the generic database 2 are only passed on weekly to associated generic database access objects 28. These changes could also be passed on immediately. Furthermore, it is also possible to store a history with respect to a client-proprietary database 30, with previous versions of said client-proprietary database 30 being stored in the history. For example, it is possible to view the impact of various changes to a client-proprietary database 30 on a group of queries 35.
    Figure 7 shows how a new data field 4 can be added 300 to an existing clinical trial report 3 in a client-proprietary database 30. The steps are very similar to adding 200 a new clinical trial report 3 with associated data fields 4 to a client-proprietary database 30. A client-specific database - access object 30 is used to look up 301 a corresponding data field 4 in the client-proprietary database 30. If none is found, a generic database access object 28 is used to look up 302 a corresponding data field 4 in the generic database 2. If a corresponding data field 4 is found, the unique ID associated 303 with the corresponding data field 4 is used for the new data field 4. If none is found, a new unique ID is used 304. Afterwards, a message 38 is sent 305 to each associated client Entity-specific database access object 30, which is prompted to store new searches 306 in said second memory 32.
    Figure 2 shows a possible configuration of a system for performing the method explained above. The system comprises a client user interface 33, a communication means in said client user interface 33 that is provided for sending at least one of said pre-programmed searches to the associated client-specific database access objects 31 via a communication network 39, and a server system 40. The client user interface 33 is used to generate a search query 35 (as set forth above) which, through the communication means, can be transmitted via the communication network 39 to a plurality of associated client-specific database access objects 31. In Figure 2, the client-specific database is access objects 31 accommodated on the server system 40, together with the client-proprietary database 30 and the second memory 32. The server system 40 further comprises a plurality of generic database access objects 28, together with the generic database 2 and the first memory 29. In another embodiment, the generic database 2 and the client-proprietary database 30 may be housed on different servers or Server systems, which are communicatively connected via conventional telecommunication networks.
    The methods and systems of the present invention described herein, or any part or means thereof, can be implemented on or by means of computer or Server systems for general use, using data security and communication means for general use, which in case of are known to those skilled in the art.
    权利要求:
    Claims (9)
    [1]
    Conclusions
    A computer-implemented method for analyzing clinical trial data combining publicly accessible clinical trial data with client-proprietary clinical trial data, characterized in that the method comprises: a. Providing a generic database (2) that is public contains accessible clinical trial data, the clinical trial data comprising a multitude of clinical trial reports (3), with each clinical trial report (3) containing at least the following data fields (4): i. name (5) of the test; ii. at least one researcher (6); iii. at least one test site (7); and iv. at least one medical indication (8), wherein the generic database (2) further comprises a system of unique IDs associated with each test report (3), each researcher (6), each site (7) and each medical indication (8) ), and mutual relationships defined between the unique IDs of the multitude of clinical trial reports (3), to enable searches based on each of these unique IDs in the generic database (2); b. providing a plurality of generic database access objects (28) each loading searches based on at least one of the unique IDs in the generic database (2) and storing the result of the search in a first memory (29); c. providing a plurality of client-specific database access objects (31) for a plurality of clients, each client-specific database access object (31) loading searches from a client-proprietary database (30) and storing it in a second memory (32), wherein the client-proprietary database (30) contains client-proprietary clinical trial data and wherein the client-proprietary clinical trial reports (3) is associated with the same system of unique IDs as the system of unique IDs used in the generic database ( 2); d. providing a client user interface (33) with a plurality of pre-programmed searches that are provided to be sent to an associated client-specific database access object (31) and that contain a combination of said unique IDs; and e. sending at least one of said pre-programmed searches to the associated client-specific database access objects (31) and processing the transmitted search query (35) by means of said client-specific database access object (31), which comprises: i. for those unique IDs (31) in the received search query (35) for which client-proprietary data is present in the second memory (32), loading relevant client-proprietary data from the second memory (32); ii. for those unique IDs in the received search query (35) for which no client-proprietary data is present in the second memory (28), communicating with at least one of the generic database access objects (28) to obtain relevant publicly accessible data; iii. compiling a search result (36) that contains the relevant client-proprietary data and the relevant publicly available data; and iv. sending the composite search result (36) back to the client user interface (33).
    [2]
    A computer-implemented method according to claim 1, wherein the step of providing a plurality of client-specific database access objects (31) for a plurality of clients comprises: associating with the client-proprietary clinical trial reports (3) the same system of unique IDs as the system of unique IDs used in the generic database (2); comparing, by means of the client-specific database access object (31), the client-proprietary data with the publicly accessible data; and storing the client proprietary data in the second memory (28) if it is more accurate or complete than the publicly accessible data.
    [3]
    A computer-implemented method according to any of the preceding claims, wherein each clinical trial report (3) further comprises at least one of the following data fields (4): a number of publications associated with a researcher; a personal score associated with a researcher; a therapeutic discipline (9) associated with a medical indication; a treatment (11) associated with a medical indication; an organization (13); a person (19) associated with an organization; a location associated with an organization (18); a number of patients from a clinical trial; a start date of a trial (14); an end date of a test (15); and a status of a test (16), wherein the generic database (2) further comprises additional unique IDs associated with at least one of these data fields (4), and additional mutual relationships defined between at least one of the unique IDs and additional unique IDs from the multitude of clinical trial reports (3).
    [4]
    A computer-implemented method according to any of the preceding claims, further comprising the step of adding a new clinical trial report (3) with data fields (4) to the generic database (2), which comprises the steps of: a. associating a new unique ID with the new test report (3); b. activating a plurality of generic database access objects (28) to look up corresponding data fields (4) of clinical trial reports in the generic database (2); c. associating the data fields (4) of the new clinical trial report with the same unique IDs or corresponding data fields (4) of clinical trial reports if such corresponding data fields of clinical trial reports are present in the generic database (2); d. associating the data field (4) of the new clinical trial report with a new unique ID if no corresponding data field (4) of a clinical trial report is present in the generic database (2); e. sending a message (38) to each generic database access object (28) provided for loading searches based on at least one unique ID associated with at least one of the data fields (4) of the new clinical trial report; and f. activating any generic database access object (28) that has received said message (38) for loading searches based on said at least one unique ID associated with said data field (4) of the new clinical trial report and storing of the result of the search in the first memory (29).
    [5]
    A computer-implemented method according to any of the preceding claims, further comprising the step of adding a new clinical trial report (3) with data fields (4) to a client-proprietary database (30), comprising the following steps: a. associating a new unique ID with the new test report (3); b. activating at least one client-specific database access object (31) to look up corresponding data fields (4) of clinical trial reports in the client-proprietary database (30); c. associating the data fields (4) of the new clinical trial report with the same unique IDs of corresponding data fields (4) of clinical trial reports, if such corresponding data fields (4) of clinical trial reports are present in the client-proprietary database (30); d. activating at least one generic database access object (28) to look up corresponding data fields (4) of clinical trial reports in the generic database (2); e. associating the data fields (4) of the new clinical trial report with the same unique IDs of corresponding data fields (4) of clinical trial reports, if such corresponding data fields (4) of clinical trial reports are present in the generic database (2); f. associating the data field (4) of the new klini log test report with a new unique ID if no corresponding clinical trial data field (4) is present in one of the generic database (2) and the client-proprietary database (30); g. sending a message (38) to each client-specific database access object (31) provided for loading searches based on at least one unique ID associated with at least one of the data fields (4) of the new clinical trial report ; and H. activating each client-specific database access object (31) that has received said message (38) to load searches based on the at least one unique ID associated with said data field (4) of the new clinical trial report and the result of the search in the second memory (32).
    [6]
    A computer-implemented method according to any of the preceding claims, further comprising the step of modifying a data field (4) of an existing clinical trial report in the generic database (2), which comprises the following steps of: message (38) to each generic database access object (28) provided for loading searches based on the unique ID associated with the data field (4) of the existing clinical trial report; and activating any generic database access object (28) that has received said message (38) to load searches based on the unique ID associated with the data field (4) of the existing clinical trial report and the result of the store the search in the first memory (29).
    [7]
    A computer-implemented method according to any of the preceding claims, further comprising the step of modifying a data field (4) from an existing clinical trial report to a client-proprietary database (30), comprising the following steps of: message (38) to each client-specific database access object (31) provided for loading searches based on the unique ID associated with the data field (4) of the existing clinical trial report; and activating each client-specific database access object (31) that has received said message (38) to load searches based on the unique ID associated with the data field (4) of the existing clinical trial report and the result of the store the search in the second memory (32).
    [8]
    A computer-implemented method according to any of the preceding claims, further comprising the step of adding a new data field (4) from a clinical trial report to an existing clinical trial report (3) in a client-proprietary database (30), the following steps comprises: a. activating at least one client-specific database access object (31) to look up a corresponding data field (4) of a clinical trial report in the client-proprietary database (30); b. associating the data field (4) of the new clinical trial report with the same unique ID as a corresponding data field (4) of a clinical trial report, if such a corresponding clinical trial report data field (4) is present in the client proprietary database (30); c. activating at least one generic database access object (28) to look up a corresponding data field (4) of a clinical trial report in the generic database (2); d. associating the data field (4) of the new clinical trial report with the same unique ID as a corresponding data field (4) of a clinical trial report, if such a corresponding data field (4) of a clinical trial report is present in the generic database (2); e. associating the data field (4) of the new clinical trial report with a new unique ID if no corresponding data field (4) of a clinical trial report is present in the generic database (2) nor in the client proprietary database (30); f. sending a message (38) to each client-specific database access object (31) that is provided for loading searches based on the unique ID associated with the data field (4) of the new clinical trial report; scary. activating each client-specific database access object (31) that has received said message (38) to load searches based on the unique ID associated with said data field (4) of the new clinical trial report and the result of the search to store in the second memory (32).
    [9]
    A system for analyzing clinical trial data combining publicly accessible clinical trial data with client-proprietary clinical trial data, characterized in that the system comprises: a. A server system (40) that has a generic database (2) includes publicly available clinical trial data, where clinical trial data includes a multitude of clinical trial reports (3), each report containing at least the following data fields (4): i. name (5) of the test; ii. at least one researcher (6); iii. at least one test site (7); and iv. at least one medical indication (8), wherein the generic database (2) further comprises a system of unique IDs associated with each test report (3), each researcher (6), each site (7) and each medical indication (8) ), and mutual relationships defined between the unique IDs of the multitude of clinical trial reports (3), to enable searches based on each of these unique IDs in the generic database (2); b. a plurality of generic database access objects (28) housed on said server system and in communication with said generic database, each of which is provided for loading searches based on at least one of the unique IDs in the generic database (2) and storing the result of the search in a first memory (29); c. a plurality of client-specific database access objects (31) housed on said server system and in communication with said generic database access objects, each of which is provided for loading searches from a client-proprietary database (30) and storing them in a second memory (32), wherein the client-proprietary database (30) contains client-proprietary clinical trial data and wherein the same system of unique IDs is associated with the client-proprietary clinical trial records (3) stored in the second memory (32) as the system of unique IDs used in the generic database (2); d. a client user interface (33) with a plurality of pre-programmed searches, which are provided to be sent to an associated client-specific database access object (31) and which contain a combination of said unique IDs; and e. a message means in said client user interface (33) provided for sending at least one of said pre-programmed searches to the associated client-specific database access objects (31) via a communication network (39), said client-specific database access object being further provided of an algorithm that, when executed on said client-specific database object, processes said transmitted search query (35) by: i. for those unique IDs in the received search query (35) for which client-proprietary data is present in the second memory (32), load relevant client-proprietary data from the second memory (32); ii. for those unique IDs in the received search query (35) for which no client-proprietary data is present in the second memory (32), to communicate with at least one of the generic database access objects (28) to obtain relevant publicly accessible data; iii. compiling a search result (36) that contains the relevant client-proprietary data and the relevant publicly available data; and iv. sending the composite search result (36) back to the client user interface (33).
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