JP4421169B2 - Pharmaceutical evaluation system - Google Patents

Description

[0001]
BACKGROUND OF THE INVENTION
The present invention relates to a drug evaluation system capable of managing drug evaluation data according to a human genetic pattern.
[0002]
[Prior art]
In general, pharmaceuticals are manufactured and sold through “creation”, which searches for materials that are the source of drugs, “preclinical” in which animal experiments are conducted, and “clinical”, which is administered to the human body to examine effects and side effects. . And even after a new drug is sold, a post-marketing surveillance (GPMSP) of the drug is conducted, and a person in charge of the pharmaceutical company visits a medical institution to collect information on efficacy and side effects.
[0003]
[Problems to be solved by the invention]
Although pharmaceuticals are produced in response to specific diseases, it is known that the effects and side effects of pharmaceuticals may differ depending on the patient's genotype. However, it is difficult to conduct tests (clinical trials) to confirm the effects and side effects of all SNP (single nucleotide polymorphism) combination patterns (haplotypes) indicating individual differences in the genome in terms of experimental period and cost. is there.
[0004]
In the medical field, a doctor selects and administers a medicine corresponding to a patient's disease with reference to data provided by a pharmaceutical company. However, as described above, the effects and side effects of the medicine may differ depending on the patient's genotype, and therefore, a contrivance is made such as adjusting the prescription based on the experience of the doctor or the like by diagnosis after medication.
[0005]
Part of the knowledge gained at each medical site is fed back to pharmaceutical companies through presentations at academic conferences and information gathering activities by medical information representatives (MRs), but the quality of information varies and quantitative data There is no system for daily measurement and feedback, and there is a problem that knowledge information obtained in the medical field is not fully utilized and is wasted.
[0006]
The present invention has been made in view of the above problems, and its purpose is to classify and manage pharmaceutical evaluation data for each human genetic pattern, and to reflect the information collected after the marketing of the pharmaceutical in the evaluation data. It is to provide a pharmaceutical evaluation system that can be used.
[0007]
[Means for Solving the Problems]
In order to solve the above problems, the drug evaluation system according to the present invention classifies human genes into a plurality of patterns, and associates the evaluation of drug names, drug effects, metabolic changes, effects, and side effects for each gene pattern, respectively. A first database to be managed, a correction means for correcting all or part of the data of the medicine based on the operation results of the medicine registered in the first database, and data corrected by the correction means are held. A second database.
[0008]
The first database and the second database basically have a common data structure, and together manage and classify drug names, drug effects, metabolic changes, effects, and side effects by gene pattern. However, the registration items are not limited to the above. In addition to the above, for example, the name of the company providing the drug (pharmaceutical company name), sales price, release date, availability of health insurance, sales record (use record), product features, use record in other countries It is also possible to add evaluations and remarks. Further, the registration items of the first database and the second database do not need to be completely coincident, and items unique to each database may be provided.
[0009]
Here, as the “evaluation of effects and side effects”, for example, an evaluation ranked by numbers, alphabets, etc., preferably quantified evaluation, such as 1 to 10 and A to D, may be adopted. it can. Note that the evaluation data is not limited to rank evaluation, but may be supplementary data such as text and images describing the progress of medical treatment. As a result, the result of actual administration can be reflected in the evaluation of the drug after the drug is marketed, and the accuracy of the data can be improved. On the other hand, referring to the second database in the medical field or the like can help to select a medicine suitable for the patient's disease and gene pattern. When a patient having a gene pattern that could not be tested at the clinical trial stage is treated in the medical field, the medication effect on the patient with the new gene pattern can be reflected in the second database. Therefore, as long as the drug is actually used, the evaluation data can be collected and analyzed almost permanently, and the accuracy of the drug evaluation data can be improved.
[0010]
Here, a haplotype can be adopted as the gene pattern, and it is preferable that the correction means corrects at least the evaluation of effects and side effects based on the operation results.
[0011]
In one aspect of the present invention, drug candidate presentation means for searching the second database based on the patient's disease type and haplotype and presenting effective drug candidates to the patient is further provided.
[0012]
For example, the medicine candidate presentation means searches the second database using the patient's disease (disease) as a search key. Thereby, all the pharmaceuticals corresponding to the disease are listed as candidate drugs. Next, by searching for a disease-response candidate drug using a patient's haplotype as a search key, it is possible to extract a drug whose specific effect and side effect evaluation is known for that haplotype. In this way, the drug candidate presentation means can extract candidate drugs in two stages: “disease-response candidate drugs” regardless of haplotype, and “diseases and haplotype candidate drugs” having evaluation by haplotype. If an assessment is not made according to the patient's haplotype, the physician will select among the disease-response candidates. The diagnosis result after the medication is registered in the second database as evaluation data for an unregistered haplotype.
[0013]
In one aspect of the present invention, an index for selection based on at least an evaluation of effects and side effects is calculated for all or a part of each drug listed as candidates, and the index is presented in association with the presented drug. And a selection index presenting means.
[0014]
The “indicator for selection” is calculated based on at least the effects and side effects of the drug. For example, simply, a value obtained by subtracting the side effect value from the effect value of each drug listed as a candidate can be used as an index for selection (also referred to as a selection index or a selection index). In addition, an index for selection can be derived by other methods such as calculating with weighting effect values and side effect values. Further, for example, an index for selection can be derived by adding factors other than the effects and side effects such as the severity of a patient's medical condition and the cost of treatment.
[0015]
In one aspect of the present invention, the apparatus further includes a comparison result presenting unit that compares the first database and the second database, and presents the comparison result between the initial data and the data after operation for all or a part of each drug. .
[0016]
By presenting the comparison result, it is possible to determine whether or not the effects and side effects as originally planned are realized.
[0017]
In another aspect of the present invention, a preset initial evaluation value is registered in each of the first database and the second database as an evaluation of effects and side effects for each haplotype of the pharmaceutical product.
[0018]
That is, when the evaluation of the effect and the side effect cannot be collected in advance, a predetermined initial value is set. For example, for a haplotype that has not been tested at the clinical trial stage, a preset initial evaluation value is set. In addition, for example, in the case of a commercially available drug (such as a popular drug) without considering the effects and side effects of each haplotype, preset initial evaluation values are set for all haplotypes.
[0019]
Here, as an initial evaluation value setting method, various methods can be adopted as follows. For example, when the evaluation for one or a plurality of haplotypes is known in advance, an initial evaluation value can be set based on the known evaluation. For example, when there is no evaluation for each haplotype, a common initial evaluation value can be set for all haplotypes. When the evaluation of the effect and side effect is obtained for one or more haplotypes, for unknown haplotypes, the evaluation of known haplotypes can be adopted as the initial evaluation value as it is, or estimated from the known evaluation. Can be adopted as the initial evaluation value. Furthermore, an initial evaluation value common to all unknown haplotypes can be set, or different initial evaluation values can be set for each unknown haplotype. In addition, for example, a common initial evaluation value is set for all unknown haplotypes for a certain disease, and a different initial evaluation value is set for each unknown haplotype for other diseases. Accordingly, the method for setting the initial evaluation value can be changed.
[0020]
A pharmaceutical evaluation system according to another aspect of the present invention includes a first computer that generates initial evaluation data of a pharmaceutical, a second computer that generates operation results of the pharmaceutical, and initial evaluation data acquired from the first computer. And a third computer for updating based on the operation results obtained from the second computer.
[0021]
The third computer includes a first database for managing the initial evaluation data, a second database for managing the latest evaluation data updated by the operation results, and the operation results transmitted from the second computer. Based on the correction means for correcting all or part of the evaluation data of the medicines registered in the second database based on the type of the disease and the haplotype of the patient input from the second computer The drug candidate presentation means for presenting drug candidates effective for the patient to the second computer is compared with the first database and the second database, and initial data for all or part of each drug is compared with A comparison result presenting means for presenting the comparison result with the data after operation to the first computer, and the first and second databases are: For each haplotype, drug name of pharmaceutical, medicinal, metabolic changes, each in association with the evaluation of the effects and side effects management.
[0022]
The present invention can also be understood as a computer program for managing evaluation data of pharmaceutical products. This program can be stored in various storage media such as a memory, a PC card, a hard disk, a CD-ROM, a DVD-ROM, and a magneto-optical disk, and can be distributed via a communication network.
[0023]
DETAILED DESCRIPTION OF THE INVENTION
Hereinafter, embodiments of the present invention will be described in detail with reference to FIGS.
[0024]
FIG. 1 is a configuration explanatory diagram showing an overall outline of a pharmaceutical evaluation system according to an embodiment of the present invention.
[0025]
The center 10 is the core of this system, and can be configured with a three-layer structure of a user interface layer 11, a logic layer 12, and a database management layer 13, for example. The center 10 is connected to computers 20, 30, 40 such as pharmaceutical companies, hospitals, public institutions, and the like through a wide-area communication network CN such as the Internet so as to be able to communicate with each other.
[0026]
The center 10 can use three types of databases: an initial evaluation table database 14, a usage evaluation table database 15, and a personal haplotype database 16. The center 10 registers the clinical trial data input from the computer 20 of the pharmaceutical company in the initial evaluation table database 14. For new drugs before market entry, the same data is registered in the initial evaluation table database 14 and the use evaluation table database 15 respectively. In addition, the center 10 updates the usage evaluation table database 15 based on the actual treatment result input from the computer 30 at the medical site such as a hospital, and reflects the operation results after marketing in the database. Further, the center 10 compares the initial evaluation table database 14 and the usage evaluation table database 15 regularly or irregularly, or in response to a request from an external computer or voluntarily, and reports the comparison result. .
[0027]
Next, FIG. 2 is a block diagram showing a detailed structure of the pharmaceutical evaluation system. The structure of each of the databases 14 and 15 will be described later with reference to FIG. 3, and the overall flow will be described first with reference to FIG.
[0028]
First, the pharmaceutical company collects clinical trial data of a new drug and transmits this clinical trial data to the center 10 (S1). The center 10 registers the clinical trial data of this new drug in the initial evaluation table database 14 and the use evaluation table database 15 respectively.
[0029]
Next, in the hospital, the patient's genetic pattern is examined (S2). In the hospital, for example, a patient's SNP is examined, a haplotype that is a combination pattern of SNPs is determined, and identification information for identifying the patient, a haplotype, a disease name, and the like are transmitted to the center 10. Here, personal information such as the patient's name, age, gender, and address can be transmitted to the center 10, but it is not always necessary. There may be identification information for specifying a patient. In addition, the patient name, disease name, and the like are managed with appropriate measures such as encryption for privacy protection.
[0030]
Next, the hospital diagnoses the medical condition of the patient (S3), and accesses the center 10 to present a list of medicines suitable for treatment (S4). The center 10 reads out the disease name and haplotype of the target patient from the personal haplotype database 16 and refers to the use evaluation table database 15 to list and present drug candidates suitable for the patient's disease name.
[0031]
In the hospital, one or a plurality of candidate drugs listed are selected and administered to the patient (S5). Then, the hospital measures the effects and side effects after medication using, for example, an RNA chip, and transmits the measured effects and side effects to the center 10 (S6). The center 10 performs statistical processing based on the post-medication effect and side effect evaluation data input from the hospital, and corrects the registered contents of the use evaluation table database 15 (S7). The original data of the medication results submitted by each hospital is stored in the transaction file 17.
[0032]
A public organization such as a competent authority can make a request to the center 10 to confirm the validity of the clinical trial process (S8). When the validity evaluation request is issued, the center 10 compares the registration contents of the initial evaluation table database 14 and the usage evaluation table database 15 and presents the comparison result (S9). In addition, it is possible to request a validity evaluation request not only from public institutions but also from pharmaceutical companies and hospitals. In addition, as a result of the comparison, for example, when the effects and side effects scheduled in the clinical stage are significantly different from those at the actual treatment site, the original data in the transaction file 17 is called up and a detailed report is obtained. Can be submitted.
[0033]
Next, the initial evaluation table database 14 and the usage evaluation table database 15 will be described with reference to FIG.
[0034]
Each database 14 and 15 basically has a common data structure, for example, drug name, corresponding disease name (disease name), haplotype, metabolic change assumed by medication, quantified efficacy and side effects, ingredients, The price (cost) and remarks are related.
[0035]
In addition, the above is an example. In addition to this, for example, identification information for managing pharmaceuticals, text data and image data explaining effects and side effects, history of approval date, release date, etc., overseas use record It is also possible to manage license information such as patent rights. Further, the databases 14 and 15 do not need to have completely the same structure, and registration items unique to the databases 14 and 15 can be provided.
[0036]
The new drug that has just been marketed after the completion of the clinical trial is registered in both the initial evaluation table database 14 and the use evaluation table database 15. When the post-marketing operation results are reported to the center 10 from each hospital, the operation results are statistically processed and reflected in the usage evaluation table database 15.
[0037]
Next, FIG. 4 is a flowchart showing an outline of processing for presenting drug candidates suitable for treatment to a hospital and providing support for drug selection.
[0038]
First, the user logs in to the center 10 from the hospital computer 30 via the communication network CN (S11). At the time of login, input of predetermined authentication information such as a password, a user name, or biometric information (fingerprint, voiceprint, etc.) is required for security.
[0039]
When the doctor inputs the ID of the target patient (S12), the personal haplotype database 16 is referred to based on the input patient ID, and the disease name and the haplotype of the patient are searched. Then, the usage evaluation table database 15 is searched based on the searched disease names (and haplotypes are used if necessary) (S13). As a result, drug candidates suitable for the patient's disease are listed and displayed on the screen of the hospital computer 30 (S14).
[0040]
Next, it is determined whether or not a doctor desires assistance for selecting a medicine suitable for treatment from among the listed medicines (S15). The doctor inputs data such as the severity of the medical condition and the consent of the patient's family (S16). The center 10 comprehensively determines the effects and side effect values of the listed medicines, the severity of the medical condition, etc., calculates the medication risk (S17), and presents it on the screen of the hospital computer 30 (S18). .
[0041]
The medication risk for supporting selection from candidate drugs can be automatically calculated and displayed without waiting for a doctor's instruction. In addition, the medication risk may be calculated based only on the effects and side effects of the drugs listed as candidates without considering data such as the severity of the medical condition.
[0042]
FIG. 5A shows an example of a drug candidate list-up screen displayed on the screen of the hospital computer 30. In the screen, for example, in addition to bibliographic items such as patient name, patient haplotype, and disease name, drug candidates suitable for the patient's disease are displayed in a list format. The drug data listed as candidates is registered contents in the use evaluation table database 15. Although it is illustrated as if only a part of the data is displayed for the sake of space, all the registered data can be displayed on the screen.
[0043]
When the doctor operates the “risk calculation” button shown in the figure, risk calculation based on the effects and side effects is performed for each candidate drug as described above, and as shown in FIG. The calculated risk is displayed.
[0044]
Next, FIG. 6 is a flowchart showing an outline of processing for evaluating the validity of a clinical experiment in response to a request from a public institution or a pharmaceutical company.
[0045]
First, a predetermined authentication process is performed by accessing the center 10 from a computer 40 or the like of a public institution and logging in (S21). Next, the center 10 is requested to create and present a validity evaluation report (S22).
[0046]
The center 10 compares the registered contents of the initial evaluation table database 14 and the usage evaluation table database 15 (S23). Furthermore, the center 10 examines the difference between the data (metabolic changes, effects, side effects, etc.) scheduled at the clinical trial stage and the data based on the past administration results for each drug, and a drug with a difference of a predetermined value or more is recognized. The presence or absence of this is inspected (S24). Then, the center 10 presents the comparison result on the screen of the computer 40 (S25), and stores the transaction file 17 or the like for a drug having a significant difference between the initial evaluation data before market and the evaluation data after market. A detailed report is presented with reference (S26).
[0047]
Next, FIG. 7 shows an outline of processing when registering drug data in the initial evaluation table database 14 (or databases 14 and 15).
[0048]
First, the pharmaceutical company computer 20 and the center 10 are connected, and clinical experiment data is transmitted from the pharmaceutical company computer 20 to the center 10 (S31).
[0049]
In the center 10, it is determined whether or not the haplotype-specific effects and side effects are set for all haplotypes (S 32). If there is a haplotype for which evaluation of effects and side effects is not set, a preset initial evaluation value is set (S33).
[0050]
That is, the data registration function provided in the logic layer 12 of the center 10 registers a preset initial evaluation value when the evaluation and the side effect evaluation for each haplotype are not set.
[0051]
Since this embodiment is configured as described above, the following effects are obtained. First, the evaluation data of pharmaceuticals is classified and managed for each haplotype, and post-marketing operation results are reflected in the evaluation of pharmaceuticals, so even if all haplotypes cannot be covered by clinical experiments, haplotypes are collected by data collected after marketing. Other data can be gradually supplemented, and the reliability of the evaluation data can be increased.
[0052]
Then, by referring to the use evaluation database 15, each medical institution can select a medicine suitable for the patient's disease and haplotype, and can support prescription and dispensing.
[0053]
Furthermore, since the comparison result between the initial evaluation data and the evaluation data after operation can be reported, the validity of the clinical trial process can be objectively confirmed.
[0054]
Furthermore, even in the case of pharmaceuticals that have not been tested for haplotype-specific effects and side effects (for example, conventional and over-the-counter drugs already on the market), by setting an initial evaluation value, post-marketing data collection using this system And analysis can be performed. Therefore, the effects and side effects of each haplotype can be collected and fed back to the medical field etc. by short-term or long-term operation, and even conventional medicines can be used more effectively.
[0055]
The present invention is not limited to the above-described embodiment. A person skilled in the art can make various modifications by adding, deleting, or changing components in the embodiment. For example, a specialized organization that modifies the evaluation of the usage evaluation table database 15 may be provided outside the center 10 and the contents of the usage evaluation table database 15 may be modified by data statistically processed by the evaluation specialized organization.
[0056]
【The invention's effect】
As described above, according to the pharmaceutical evaluation system according to the present invention, the evaluation of pharmaceuticals can be managed for each human genetic pattern, and the operational performance after marketing can be reflected to improve the reliability of evaluation data. .
[Brief description of the drawings]
FIG. 1 is a block diagram showing an overall configuration of a pharmaceutical evaluation system according to an embodiment of the present invention.
FIG. 2 is a block diagram showing details of a pharmaceutical evaluation system.
FIG. 3 is an explanatory diagram showing the structures of an initial evaluation table database and a usage evaluation table database and the relationship between them.
FIG. 4 is a flowchart of processing for listing drug candidates according to a patient's disease.
FIG. 5 is an explanatory diagram showing an example of a screen for displaying drug candidates and various data.
FIG. 6 is a flowchart showing a process for evaluating and reporting the validity of a clinical experiment by comparing an initial evaluation table database and a use evaluation table database.
FIG. 7 is a flowchart showing an outline when registering drug data in a database.
[Explanation of symbols]
10 Center 11 UI Layer 12 Logic Layer 13 Database Layer 14 Initial Evaluation Table Database 15 Usage Evaluation Table Database 16 Personal Haplotype Database 17 Transaction File 20 Pharmaceutical Company Computer 30 Hospital Computer 40 Public Institution Computer

Claims (1)

Data registration means for associating evaluation data consisting of numerical values representing ranks of drug names , disease names, effects and side effects for each of a plurality of human genetic patterns , and registering them in the first database and the second database, respectively,
Information output means for outputting data registered in the first database;
For each combination of the drug name, disease name, and gene pattern , based on evaluation data consisting of numerical values representing the rank of the effect and side effect specified by the combination of the drug name, disease name, and gene pattern that received the input The numerical value representing the effect and the rank of the side effect is statistically processed, and the rank of the effect and the side effect in the evaluation data corresponding to the combination of the drug name, disease name, and gene pattern registered in the second database is calculated. Correction means for correcting a numerical value to be expressed using the result of the statistical processing;
An evaluation showing a difference greater than or equal to a predetermined value by comparing values representing ranks of the effects and side effects between the evaluation data registered in the first database and the evaluation data registered in the second database A comparison result presentation means for outputting drug data corresponding to the data;
A third database in which disease names and gene patterns are registered in association with patient IDs;
Read the disease name and gene pattern registered in the third database in association with the patient ID that accepted the input, and register in the second database in association with the read disease name and gene pattern. Drug candidate presentation means for reading and outputting the name of a drug that is present,
All or part of the medicament mentioned above output, the index calculating means for calculating an index by subtracting the evaluated data side effects from the evaluation data of the effect corresponding to said medicament,
A selection index presenting means for outputting the index in association with the outputted medicine name ;
A pharmaceutical evaluation system characterized by comprising:

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