KR102619888B1 - Clinical trial management system - Google Patents

Abstract

The present invention relates to a clinical trial management system, and more specifically, a clinical trial management system that enables the subjects participating in a clinical trial to identify their disease status in real time through the drugs they are taking and efficiently manage the clinical trial. It's about.
The present invention is a clinical trial management system, which includes a storage unit that receives and stores subject information including drug information about drugs taken by pregnancy test subjects, and a storage unit that classifies the subject information by disease category using the drug information. A server including a classification unit that generates classification information; and an administrator client that receives and outputs the subject information and classification information.

Description

CLINICAL TRIAL MANAGEMENT SYSTEM}

The present invention relates to a clinical trial management system, and more specifically, to a clinical trial management system that allows the subject's disease status to be identified in real time through the drugs taken by the clinical trial subject and the clinical trial to be managed efficiently. will be.

A prerequisite for reducing new drug development costs and increasing success rates is efficient conduct of clinical trials.

A clinical trial is a test that confirms the safety and effectiveness of a new drug that has passed the pre-clinical trial stage by administering the drug to animals to test its toxicity and safety by directly applying it to the human body.

These clinical trials are largely divided into three stages. Phase 1, in which the test drug is applied to humans for the first time, examines the absorption, distribution, metabolism, and excretion process of the drug, and Phase 2 examines the appropriate drug dosage and safety. Once the optimal dose is confirmed in phase 3, it can be marketed.

The above-mentioned clinical trial is the most important and most expensive step in developing a new drug. Selecting patients who will respond well to the drug being developed and enrolling them in the clinical trial quickly increases the efficiency and likelihood of success of new drug development.

These clinical trials are conducted by clinical trial managers (Clinical Research Associate (CRA), Clinical Research Coordinator (CRC), etc.).

CRA develops and designs clinical trial protocols and case records in consultation with medical staff with medical information, submits them to the clinical trial review committee, and selects researchers or clinical trial institutions to participate in clinical trials. In addition, we educate project participants, including researchers, and check whether the research subjects are suitable for the clinical trial, whether the research subject's consent form is obtained, and whether the clinical trial is ethical, scientific, and conducted in compliance with relevant laws and clinical trial protocols. Do the work.

On the other hand, in clinical trials, a situation arises in which test subjects who have a medical history depending on the treatment being tested or who take the drug periodically due to the above-mentioned medical history must be excluded from the clinical trial, and the above-mentioned administrator (CRA, etc.) It is difficult to determine the condition and medications taken, and there are cases where a large amount of data is reviewed at once and visually checked one by one, resulting in things being missed.

In particular, if you take a drug that should be excluded from the clinical trial during the clinical trial rather than before the clinical trial, as this is later discovered, additional clinical trials are required to fill the number of subjects required for the clinical trial, resulting in additional cost and waste of time. There were problems, etc.

The technology behind this application is disclosed in Korean Patent Publication No. 10-2042473.

The present invention was created to solve the above problems, and its purpose is to provide a clinical trial management system that can check the subject's disease status in real time and allows administrators to manage clinical trials efficiently and effectively.

The purpose of the present invention is to provide a clinical trial management system that improves the accuracy of clinical trials and effectively manages the time and cost required for clinical trials.

The present invention, aimed at solving the above problems, has the following configuration and characteristics.

It is a clinical trial management system, which includes a storage unit that receives and stores subject information including drug information about drugs taken by pregnancy test subjects, and a storage unit that uses the drug information to generate classification information that classifies the subject information by disease category. A server including a classification unit; and an administrator client that receives and outputs the subject information and classification information.

In addition, the storage unit receives and stores standard information on diseases that prevent participation in clinical trials, and the server compares the classification information with the standard information, and determines whether the disease in the standard information corresponds to the disease in the classification information. In this case, it may further include a comparison determination unit that generates notification information that matches the subject information.

In addition, the classification information includes an identification code that matches the disease category, and when the server receives search information including an identification code from the manager client, the server sends subject information matching the identification code to the manager client. Can be transmitted.

The present invention having the above configuration and features has the effect of being able to check the subject's disease state in real time, allowing administrators to manage clinical trials efficiently and effectively.

The present invention has the effect of improving the accuracy of clinical trials and effectively managing the time and cost required for clinical trials.

1 is a schematic block diagram to explain a clinical trial management system according to an embodiment of the present invention.
Figure 2 is a diagram for explaining the process of outputting point areas and solid lines in an additional embodiment of the present invention.
Figure 3 is a diagram for explaining the process of outputting a capture area in an additional embodiment of the present invention.

Since the present invention can be subject to various changes and can have various forms, implementation examples (or embodiments) will be described in detail in the text. However, this is not intended to limit the present invention to a specific disclosed form, and should be understood to include all changes, equivalents, and substitutes included in the spirit and technical scope of the present invention.

The terms used in this specification are merely used to describe specific implementation examples (sun, aspect, aspect) (or examples), and are not intended to limit the present invention. Singular expressions include plural expressions unless the context clearly dictates otherwise. In this application, terms such as ~include~ or ~consist of~ are intended to designate the presence of features, numbers, steps, operations, components, parts, or combinations thereof described in the specification, but are not intended to indicate the presence of one or more other features. It should be understood that this does not exclude in advance the possibility of the existence or addition of elements, numbers, steps, operations, components, parts, or combinations thereof.

Unless otherwise defined, all terms used herein, including technical or scientific terms, have the same meaning as commonly understood by a person of ordinary skill in the technical field to which the present invention pertains. Terms defined in commonly used dictionaries should be interpreted as having a meaning consistent with the meaning in the context of the related technology, and unless explicitly defined in the present application, should not be interpreted in an ideal or excessively formal sense. No.

~First~, ~Second~, etc. described in this specification are only used to distinguish different components, and are not limited by the order of manufacture, and the names are used in the detailed description and claims of the invention. may not match.

Throughout the specification of the present application, when a part is said to be “connected” to another part, this means not only “directly connected (electrical connection capable of communication)” but also “indirectly connected” with another element in between. (Electrical connection capable of communication)" is also included.

1 is a schematic block diagram to explain a clinical trial management system according to an embodiment of the present invention.

The clinical trial management system (S) (clinical trial management system using prohibited drugs and drug classification) according to an embodiment of the present invention is for efficient management of clinical trials, and is hereinafter referred to as 'this system' for convenience of explanation. Let's call it .

Referring to Figure 1, this system (clinical trial management system (S) according to an embodiment of the present invention) includes a server (1) and an administrator client (2).

The server 1 may include a storage unit 11 (eg, a storage disk, etc.) that receives and stores subject information including drug information regarding the medicine (medication) taken by the clinical trial subject.

The above-mentioned drug information (drug information) is important medical information that allows the subject's major medical history to be accurately determined. At the same time, it allows you to check medical information that may have been accidentally omitted. This is often an important clue in determining whether a subject meets the exclusion criteria for clinical trials.

The above-mentioned subjects are those who have agreed to participate in the clinical trial after the clinical trial researcher recruits participants for the clinical trial. The above-mentioned subject information includes the clinical trial subject's vital signs information and physical examination results in addition to the above-mentioned drug information (drug information). It may additionally include one or more of information, blood test result information, medical history information, and subject identification information (eg, name, age, contact information, etc.).

Although not shown, the above-mentioned subject information is transmitted from the hospital's main server, entered into EDC (electronic data capture), or entered from a terminal, PC, etc. on which the administrator client (2) described later is installed, or from the subject. It may be input and transmitted from a subject client installed on a terminal or PC owned by the user.

The server 1 includes a classification unit 12 that uses the drug information to generate classification information that classifies the subject information into disease categories. The above classification information may include list information of subject information matching the disease category name.

Various control configurations known to those skilled in the art (e.g., various electronic devices or electronic modules such as computers and processors) can be applied to the classification unit 12, the comparison and judgment unit 13 and the search unit 14, which will be described later. there is. Illustratively, the classification unit 12, the comparison and judgment unit 13 and the search unit 14, which will be described later, contain signals or commands (information) generated according to programs or algorithms included therein. comparative judgment unit (13). It may be transmitted to the search unit 14, the administrator client 2, etc. For example, a classification unit 12 and a comparison judgment unit 13 described later. The search unit 14 may be connected to the classification unit 12, the storage unit 11, and the manager client 2, respectively, by wire or wirelessly.

The classification unit 12 can receive the subject information from the storage unit 11.

At this time, the above-mentioned drug information may include an ATC (Anatomical Therapeutic Chemical) code assigned by matching a term (eg, disease name) entered through medical coding using a medical dictionary. You can.

As an example, the classification unit 12 may classify a plurality of subject information into disease categories using the ATC code to generate classification information.

By way of example, an identification code may be assigned to each disease category, and thus the classification information may include the identification code. Therefore, the identification code can be matched to the subject information by the classification unit 12.

For example, when the drug information of one of the plurality of subject information (hereinafter referred to as first subject information) includes the ATC code 'C03CA01' (furosemide), the classification unit 12 divides the subject information into the first subject information. Subject information can be classified into disease categories in which furosemide is used, an identification code can be assigned, and classification information containing subject information matching the identification code can be generated.

The manager client 2 can receive and output the subject information and classification information.

Through this, subject information can be classified by disease category and output from the administrator client (2). Using a terminal or PC where the administrator client (2) is installed, the administrator (e.g. CRA, etc.) can In addition to disease information, the subject's medical history can be more accurately determined through the medications being taken. Administrators can easily monitor subjects by salting them by disease through classification information, and subjects who do not meet the clinical trial conditions can be early excluded from the clinical trial. This has the advantage of effectively reducing the cost and time required for clinical trials. In addition, the administrator's workload can be reduced because the administrator does not have to manually check the subject's medical history and medications.

Meanwhile, when the server 1 receives search information including an identification code from the manager client 2, the search unit 14 transmits subject information matching the identification code to the client 2. ) may include.

The above search information may include the above-mentioned ATC code in addition to the identification code for the disease category, which allows the administrator to more quickly and easily find subjects taking specific drugs or having a specific medical history among multiple subjects. Through this, subjects can be observed in real time, so it is possible to judge whether investigators who take additional drugs (additional doses due to worsening health conditions, etc.) during the clinical trial process as well as before the clinical trial are eligible for clinical trials and respond immediately. There is an advantage to being able to

Meanwhile, the storage unit 11 can receive and store standard information regarding diseases that prevent participation in clinical trials. The above-mentioned reference information may be generated from the above-described manager client 2.

The above-mentioned standard information may include the disease name related to the disease, the above-mentioned ATC code, or identification code. The disease name may have been converted into a ‘terminology’ created by medical coding.

At this time, the server 1 compares the classification information and the standard information, and if the disease in the standard information corresponds to the disease in the classification information, the server 1 includes a comparison judgment unit 13 that generates notification information matching the subject information. It can be included.

As described above, each of the classification information and reference information may include an ATC code or identification code in addition to the disease name. Therefore, the comparison judgment unit 13 compares the ATC code or identification code of each of the classification information and reference information to provide classification information and If the ATC code or identification code of each standard information corresponds, the above notification information can be generated.

The above-described notification information may include the above-mentioned subject information data and an alarm sound signal, and the above-mentioned manager client 2 may receive the above-described notification information and output the above-described subject information and an alarm sound signal. .

This has the advantage of allowing administrators to quickly recognize subjects who do not meet the clinical trial conditions in real time and manage the clinical trial quickly and efficiently.

That is, subjects who cannot participate in the clinical trial due to a history of taking a specific class of drugs, subjects who cannot participate in the clinical trial because they have a specific class of disease, or dropouts due to taking a specific class of drugs during the clinical trial period. It has the advantage of being able to quickly and accurately identify subjects who need to be treated.

Figure 2 is a diagram for explaining the process of outputting point areas and solid lines in an additional embodiment of the present invention. Figure 3 is a diagram for explaining the process of outputting a capture area in an additional embodiment of the present invention.

Referring to FIGS. 2 and 3, the administrator client 2 captures a specific part of the terminal screen and stores it separately in a DB (DB of the terminal where the administrator client 2 is installed) or to another client (another administrator client ( 2)) Or, a situation requires transmission to the server (1).

In particular, if one of the multiple administrators disallows participation in the clinical trial of a specific subject among the multiple subjects, an image capturing the subject information and reasons for the subject who was unable to participate in the clinical trial (by way of example) The need for the above-mentioned capture interface is required in the process of reporting the image on which the subject information is output together with evidence to another administrator.

Conventionally, in order to capture images printed on the terminal screen, the mobile phone was held with one hand, the other hand was raised, the part opposite to the thumb was placed on the terminal screen, and the image was captured by moving it horizontally. , In this case, there was the inconvenience of having to use both hands to capture the image displayed on the terminal screen.

Additionally, conventionally, in order to capture an image from the terminal screen, a method of capturing was used by pressing a button such as the power button at the same time as another button. In this case, the entire area displayed on the terminal screen is captured, and the captured image is captured. In order to reduce the size, an editing interface that adjusts the captured image to a square size had to be activated.

In this case, there is a problem in that the remaining part other than the area to be captured is captured, causing the size of the captured image to become too large (problems such as taking up storage disk space and slowing down the transmission speed as the data to be transmitted becomes larger), and also causes malfunctions, etc. There were problems that were difficult to prevent.

In order to compensate for the above problems, the manager client 2 may include a capture interface that can capture a selected area on the terminal screen using only one hand.

The capture interface is intended to overcome the problems of the conventional method, allowing the area to be captured to be efficiently captured to the maximum size, but also allowing capture using one hand. In other words, through this, a specific desired part can be enlarged, and damage to the terminal can be effectively prevented by making it easier to hold the terminal.

The capture interface will be described in more detail below. Referring to FIG. 2, the capture interface is configured so that when one of the fingers (example, index finger) and the other (example, thumb) touch the terminal screen at the same time (see [A] in FIG. 2), one of the fingers A first point (Z1) may be output at the first point where one is touched, and a second point (Z2) may be output at a second point where the other is touched.

When touching the terminal screen with the two fingers, support the lower part of the terminal with the remaining three fingers (middle finger, ring finger, little finger), wrap the terminal around the terminal, and touch the terminal screen with the thumb and index finger to use the terminal with one hand. You can grab it.

The capture interface surrounds each of the first point (Z1) and the second point (Z2) when the touch is released from each of the first point (Z1) and the second point (Z2), but has an area larger than the first joint of the finger. A first point area (Z3) and a second point area (Z4) having can be output, respectively (see [B] in FIG. 2).

The hand generally has a metacarpal (palm, back) with a skeleton of the metacarpal bone and five fingers extending from the metacarpal. The bones of the fingers include the first joint bone connected to the metacarpal bone, the middle joint bone connected to the first joint bone, and the terminal joint bone connected to the middle joint bone. The first joint bone of the hand is a part that uses the terminal joint bone as the skeleton. This is where nails, etc. are provided.

The area of the first joint of the finger mentioned above may mean the planar area (area on a plane) of the first joint when viewed from a plane with the hand with the back of the hand facing upward.

As will be explained in more detail in the following description, the above-described first point area (Z3) and second point area (Z4) are areas touched by a finger, and as described above, the first point area (Z3) and the second point area (Z4) are ) has an area larger than the first joint of the finger, so the user can easily touch the first point area (Z3) and the second point area (Z4). In other words, when a finger touches the terminal screen, it is difficult to touch only a certain point and an area is touched, but as the finger is tilted, it may be difficult to touch a specific point. Since the capture interface outputs the first point area (Z3) and the second point area (Z4), the user can be guided to more easily touch the area where the capture interface induces a touch.

The capture interface is in a state where the first point area (Z3) and the second point area (Z4) are output and neither of the first point area (Z3) or the second point area (Z4) is touched. When the remaining areas other than the first point area (Z3) and the second point area (Z4) are touched on the terminal screen, the first point area (Z3) and the second point area (Z4) can be deleted. .

Conversely, the capture interface outputs a first black solid line (Z5) along the first drag path when the first point area (Z3) is touched and dragged along the first drag path to the second point area (Z4). can do.

When the capture interface releases the touch of the second point area (Z4) and maintains the re-touch state after outputting the first solid line (Z5), the first solid line (Z5) is displayed in the first point area (Z3). ) can be sequentially deleted along the first drag path, and at the same time, a second red solid line (Z6) can be sequentially output from the first point area (Z3) along the first drag path.

At this time, if the re-touch state of the second point area (Z4) is maintained for a preset time (eg, 3 seconds or 5 seconds), the first solid line (Z5) is deleted and the second solid line (Z6) is It may be output from the first point area (Z3) to the second point area (Z4) along the first drag path.

As described above, after releasing the first touch of the second point area (Z4) (after outputting the first solid line (Z5)), the re-touch state of the second point area (Z4) must be maintained for a preset period of time to activate the second solid line (Z4). By outputting (Z6), it is possible to prevent malfunctions in which part of the terminal screen is captured by touching it unintentionally, and a second solid line (Z6) is output sequentially along the first drag path in the first point area (Z3). ), the user can visually recognize to what extent the retouch state has been maintained, and visually how long the retouch state must be maintained before the second solid line (Z6) is displayed up to the second point area (Z4). can do.

Meanwhile, if the re-touch of the second point area Z4 is not maintained for a preset time, the second solid line Z6 may be deleted.

Afterwards, the capture interface outputs a second solid line (Z6) when the second point area (Z4) is touched again, or, as described above, other than the first point area (Z3) and the second point area (Z4). When the remaining area is touched, the first point area (Z3), the second point area (Z4), and the first solid line (Z5) can be deleted.

Afterwards, when the capture interface is dragged from the second point area (Z4) to the first point area (Z3) along a second drag path that is different from the first drag path, the capture interface has a red color along the second drag path. A third solid line (Z7) (see [C] in FIG. 2) can be output.

When the third solid line (Z7) is output and the touch is released in the first point area (Z3), the capture interface displays the first point area (Z3), the second point area (Z4), and the second solid line ( Z6), and the first capture area (Z8) formed by the third solid line (Z7) can be output (see [A] in FIG. 3).

Through this, the capture interface can specify the first capture area (Z8) surrounding a specific part of the image that has various shapes rather than simply being rectangular as in the prior art.

The capture interface is generated when the outside of the capture area (Z8) (opposite the inside of the capture area (Z8)) is touched on the terminal screen and then dragged to the inside, which is the center side of the first capture area (Z8). A second capture area (Z9) whose size is reduced compared to the first capture area (Z8) can be output (see [B] in FIG. 3), and conversely, when dragged in a direction (outside) opposite to the inside, the second capture area (Z9) can be output. A third capture area (Z10) (see [C] in FIG. 3) of which the size of the first capture area (Z8) is enlarged can be output.

Through this, the user can output the second capture area (Z9) or third capture area (Z10) while checking the image in the first capture area (Z8) with the naked eye without blocking it with a finger.

The capture interface outputs the second solid line (Z6) and the third solid line (Z7) along the path where the finger touches the terminal screen. When the finger touches the terminal screen, an area is touched, not a specific point, and thus the The second solid line (Z6) and the third solid line (Z7) may not be output exactly on the path desired by the user.

At this time, as described above, the capture interface touches the outer area of the first capture area (Z8) after the first capture area (Z8) is output and selects the second capture area (Z9) or the third capture area (Z9) depending on the direction in which it is dragged. By printing Z10), you can easily adjust the size of the area you want to capture with one finger.

Afterwards, when the inside of the first capture area (Z8), the second capture area (Z9), or the third capture area (Z10) is touched, the capture interface displays the first capture area (Z8) or the second capture area (Z10). Capture information about the image of the third capture area (Z9) or the third capture area (Z10) can be generated.

The above-mentioned capture information may be stored in a storage module such as a DB of the terminal or transmitted to other clients as described above.

The present invention described above with reference to the accompanying drawings can be modified and modified by those skilled in the art, and such modifications and changes should be construed as falling within the scope of the present invention.

Clinical trial management system: S
Server: 1 Storage: 11
Classification section: 12 Comparison judgment section: 13
Search Department: 14 Administrator Clients: 2

Claims (4)

As a clinical trial management system,
A server including a storage unit that receives and stores subject information including drug information about drugs taken by a pregnancy test subject, and a classification unit that uses the drug information to generate classification information that classifies the subject information into disease categories; and
an administrator client that receives and outputs the subject information and classification information;
Including,
The storage unit,
Receive and store standard information on diseases that prevent participation in clinical trials,
The server is,
Further comprising a comparison judgment unit that compares the classification information and the reference information, and generates notification information matching the subject information when the disease in the reference information corresponds to the disease in the classification information,
The classification information includes an identification code that matches the disease category,
When the server receives search information including an identification code from the manager client, it transmits subject information matching the identification code to the manager client,
The manager client includes a capture interface for capturing a selected area on the terminal screen,
The capture interface displays a first point (Z1) and a second point at each of the first point touched by one of the fingers and the second point touched by the other finger when one of the fingers and the other one touch the terminal screen at the same time. (Z2) prints each,
When the touch is released at each of the first point (Z1) and the second point (Z2), a first point surrounding each of the first point (Z1) and the second point (Z2) and having an area larger than the first joint of the finger Output the point area (Z3) and the second point area (Z4), respectively,
After the first point area (Z3) and the second point area (Z4) are output, either the first point area (Z3) or the second point area (Z4) is displayed on the terminal screen without being touched. When an area other than the first point area (Z3) and the second point area (Z4) is touched, the first point area (Z3) and the second point area (Z4) are deleted,
When the first point area (Z3) is touched and dragged along the first drag path to the second point area (Z4), a first solid line (Z5) having black color is output along the first drag path,
When the touch on the second point area (Z4) is released and the touch is maintained after outputting the first solid line (Z5), the first solid line (Z5) is sequentially drawn starting from the first point area (Z3). It is deleted along the first drag path, and at the same time, a second solid line (Z6) in red is sequentially output along the first drag path starting from the first point area (Z3),
When the retouch of the second point area (Z4) is maintained for a preset time, the first solid line (Z5) is deleted, and the second solid line (Z6) is changed from the first point area (Z3) to the second solid line (Z5). 1 Output to the second point area (Z4) along the drag path,
If re-touching of the second point area (Z4) is not maintained for a preset time, the second solid line (Z6) is deleted,
When being dragged along a second drag path from the second point area (Z4) to the first point area (Z3), a third solid line (Z7) in red is output along the second drag path,
When the third solid line (Z7) is output and the touch is released in the first point area (Z3), the first point area (Z3), the second point area (Z4), the second solid line (Z6), Output the first capture area (Z8) formed by the third solid line (Z7),
After the outside of the first capture area (Z8) is touched on the terminal screen and then dragged to the inside, which is the center of the first capture area (Z8), a second device whose size is reduced compared to the first capture area (Z8) is displayed. Outputs a second capture area (Z9) and, when dragged in the opposite direction to the inside, outputs a third capture area (Z10) enlarged in size from the first capture area (Z8),
When the first capture area (Z8), the second capture area (Z9), or the third capture area (Z10) is touched, the first capture area (Z8), the second capture area (Z9), or the third capture area (Z10) is touched. Generate capture information about the image of the area (Z10),
A clinical trial management system in which the capture information is stored in the terminal's DB. delete delete delete

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