CN113192594A - Method, system and computer readable medium for drug delivery in clinical trials - Google Patents
Method, system and computer readable medium for drug delivery in clinical trials Download PDFInfo
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Abstract
The invention relates to a medicine supply method, a medicine supply system and a computer readable medium for clinical trials. The method comprises the following steps: extracting a minimum inventory amount of the medication from a supply schedule of the medication, the supply schedule corresponding to a clinical trial center; inquiring the current remaining inventory of the medicine in a clinical test center; extracting the visiting times and visiting moments of the testees from the visiting period of the clinical test center, and extracting the dosage of the testees at each visiting time from the treatment scheme of the clinical test center, wherein the dosage corresponds to the medicine; calculating the medicine demand of the clinical test in a preset time according to the visit times, the visit time, the administration amount and the number of the testees; and calculating the difference value between the current remaining inventory amount and the minimum inventory amount, and automatically generating a transfer application form when the difference value is less than or equal to the drug demand amount, wherein the transfer application form comprises a first drug transfer amount needing to be transferred.
Description
Technical Field
The invention mainly relates to the field of clinical trial research, in particular to a medicine supply method and system for clinical trial and a computer readable medium.
Background
In some clinical trial studies, the process of dispensing medication to a subject to observe the clinical effect of the medication is involved, and in this process, the project administrator needs to count, summarize, and replenish the medication throughout the trial in time to avoid affecting the progress of the trial. For complex multi-center experiments, services such as randomized distribution, subject management, drug management and the like are provided for clinical experiments through a central stochastic system, and the clinical experiments are electronized. At present, a summary report of the visit of the released medicines can be obtained according to a central random system, so that the using condition of the medicines is known, but whether the medicines need to be supplemented or not cannot be predicted, so that the supply of the experimental medicines is not timely, and the risk is caused to the business. In addition, the production, storage and transportation of the medicine are independent and complex systems, and cannot be directly combined with a clinical trial management system, and even cannot predict and timely supplement the medicine supply according to the actual condition of the clinical trial.
Disclosure of Invention
The invention aims to provide a drug supply method, a drug supply system and a computer readable medium for timely triggering and transferring a request form to supplement a test drug.
The technical scheme adopted by the invention for solving the technical problems is a medicine supply method for clinical trials, which is characterized by comprising the following steps: extracting a minimum inventory amount of a medication from a supply schedule for the medication, the supply schedule corresponding to a clinical trial center; inquiring the current remaining inventory of the medicine in the clinical test center; extracting the visit times and visit moments of the subjects from the visit arrangement of the clinical test center, and extracting the dosage of the subjects at each visit from the treatment scheme of the clinical test center, wherein the dosage corresponds to the medicine; calculating the medicine demand of the clinical test in a preset time according to the visit times, the administration amount at the visit time and the number of the testees; and calculating a difference value between the current remaining inventory amount and the minimum inventory amount, and automatically generating a transfer application form when the difference value is less than or equal to the drug demand amount, wherein the transfer application form comprises a first drug transfer amount needing to be transferred.
In one embodiment of the present invention, the first drug delivery amount is equal to the drug demand amount.
In an embodiment of the present invention, further comprising extracting a short-term window from the supply schedule, the predetermined duration being equal to the short-term window, and calculating the medication demand according to the following formula:
ti∈(tnow,tnow+a),i＝1,…,n
wherein S isaRepresenting the drug requirement, S, over the short-term windowtiIndicating visit time t at visit number iiAn amount of drug administered, Q, to the subjectiNumber of subjects at visit number i, tnowRepresenting the current time, a representing the time length of the short-term window, and n being a positive integer.
In an embodiment of the present invention, further comprising extracting a long-term window from the supply schedule, the long-term window having a length of time greater than the short-term window, calculating the first drug delivery volume according to the following formula:
E＝Sb+min-r
tj∈(tnow,tnow+b),j＝1,…,n
wherein E represents the first medicine transporting amount, min represents the minimum stock amount, r represents the current remaining stock amount, SbIndicating the drug requirement, S, over the long-term windowtjIndicating an visit time t at a visit number jjAn amount of drug administered, Q, to the subjectjFor visit number jNumber of subjects, tnowRepresenting the current time instant, b representing the time length of the long-term window.
In an embodiment of the invention, further comprising extracting a maximum amount of inventory from the supply schedule, the method further comprises: and when the current remaining inventory amount is less than or equal to the minimum inventory amount, automatically generating the transfer request form, wherein the transfer request form comprises a second drug transfer amount to be transferred, and the second drug loading amount is equal to the difference value between the maximum inventory amount and the current remaining inventory amount.
In an embodiment of the present invention, the method further includes: comparing the first drug delivery amount and the second drug delivery amount, and taking the larger of the first drug delivery amount and the second drug delivery amount as the actual drug delivery amount of the transfer application form.
The invention also provides a medicine supply method for clinical tests to solve the technical problems, which is characterized by comprising the following steps: providing a supply schedule configuration page for a medication, the supply schedule configuration page adapted to configure a minimum inventory amount of the medication; providing a center association page, and associating a supply schedule with a clinical trial center on the center association page; and providing a system script for executing the medication providing method as described above.
In an embodiment of the invention, the supply schedule configuration page is further adapted to configure a short-term window and a long-term window, the long-term window having a length of time greater than the length of time of the short-term window, the system script adapted to calculate the medication demand based on the short-term window and the first medication delivery based on the long-term window.
In one embodiment of the invention, the drug requirement is calculated according to the following formula:
ti∈(tnow,tnow+a),i＝1,…,n
wherein S isaDrug expressed within the short term windowDemand, StiIndicating visit time t at visit number iiAn amount of drug administered, Q, to the subjectiNumber of subjects at visit number i, tnowRepresenting the current time, a representing the time length of the short-term window, and n being a positive integer.
In one embodiment of the present invention, the first drug delivery amount is calculated according to the following formula:
E1＝Sb+min-r
tj∈(tnow,tnow+b),j＝1,…,n
wherein E1 represents the first drug shipment amount, min represents the minimum inventory amount, r represents the current remaining inventory amount, SbIndicating the drug requirement, S, over the long-term windowtjIndicating an visit time t at a visit number jjAn amount of drug administered, Q, to the subjectjNumber of subjects at visit number j, tnowRepresenting the current time instant, b representing the time length of the long-term window.
In an embodiment of the invention, the provisioning schedule configuration page is further adapted to configure a maximum inventory amount, and the system script is further adapted to perform the steps of: and when the current remaining inventory amount is less than or equal to the minimum inventory amount, automatically generating the transfer request form, wherein the transfer request form comprises a second drug transfer amount to be transferred, and the second drug loading amount is equal to the difference value between the maximum inventory amount and the current remaining inventory amount.
In an embodiment of the invention, the system script is further adapted to perform the following steps: comparing the first drug delivery amount and the second drug delivery amount, and taking the larger of the first drug delivery amount and the second drug delivery amount as the actual drug delivery amount of the transfer application form.
The present invention further provides a drug supply system for clinical trials to solve the above technical problems, comprising: a memory for storing instructions executable by the processor; a processor for executing the instructions to implement the method as described above.
The present invention also provides a computer readable medium storing computer program code, which when executed by a processor implements the method as described above.
The invention predicts the drug demand in the preset time according to the visit schedule and the treatment scheme of the clinical test, and triggers the generation of the transfer request form in time according to the current residual inventory of the clinical test center and the minimum inventory of the drug in the supply schedule, and transfers the drug for the test to the clinical test center in time, thereby ensuring that the drug in the clinical test center has enough drug inventory and avoiding various problems caused by drug shortage.
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In order to make the aforementioned objects, features and advantages of the present invention comprehensible, embodiments accompanied with figures are described in detail below, wherein:
FIG. 1 is an exemplary flow chart of a drug delivery method of a clinical trial according to an embodiment of the present invention;
FIG. 2 is an exemplary block diagram of a drug delivery method of a clinical trial according to an embodiment of the present invention;
FIG. 3 is an exemplary flow chart of a drug delivery method of a clinical trial according to another embodiment of the present invention;
fig. 4 is a schematic diagram of a supply schedule configuration page of a medicine in the medicine supply method according to an embodiment of the present invention;
FIG. 5 is a schematic diagram of a center association page in the medication delivery method according to an embodiment of the invention;
fig. 6 is a schematic diagram of an waybill inquiry page in the medication supply method according to an embodiment of the present invention;
fig. 7 is a system block diagram of a drug delivery system for a clinical trial according to an embodiment of the present invention.
Detailed Description
In order to make the aforementioned objects, features and advantages of the present invention comprehensible, embodiments accompanied with figures are described in detail below.
In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present invention, but the present invention may be practiced in other ways than those specifically described herein, and thus the present invention is not limited to the specific embodiments disclosed below.
As used in this application and the appended claims, the terms "a," "an," "the," and/or "the" are not intended to be inclusive in the singular, but rather are intended to be inclusive in the plural unless the context clearly dictates otherwise. In general, the terms "comprises" and "comprising" merely indicate that steps and elements are included which are explicitly identified, that the steps and elements do not form an exclusive list, and that a method or apparatus may include other steps or elements.
The relative arrangement of the components and steps, the numerical expressions, and numerical values set forth in these embodiments do not limit the scope of the present application unless specifically stated otherwise. Meanwhile, it should be understood that the sizes of the respective portions shown in the drawings are not drawn in an actual proportional relationship for the convenience of description. Techniques, methods, and apparatus known to those of ordinary skill in the relevant art may not be discussed in detail but are intended to be part of the specification where appropriate. In all examples shown and discussed herein, any particular value should be construed as merely illustrative, and not limiting. Thus, other examples of the exemplary embodiments may have different values. It should be noted that: like reference numbers and letters refer to like items in the following figures, and thus, once an item is defined in one figure, further discussion thereof is not required in subsequent figures.
It should be noted that the terms "first", "second", and the like are used to define the components, and are only used for convenience of distinguishing the corresponding components, and the terms have no special meanings unless otherwise stated, and therefore, the scope of protection of the present application is not to be construed as being limited. Further, although the terms used in the present application are selected from publicly known and used terms, some of the terms mentioned in the specification of the present application may be selected by the applicant at his or her discretion, the detailed meanings of which are described in relevant parts of the description herein. Further, it is required that the present application is understood not only by the actual terms used but also by the meaning of each term lying within.
Flow charts are used herein to illustrate operations performed by systems according to embodiments of the present application. It should be understood that the preceding or following operations are not necessarily performed in the exact order in which they are performed. Rather, various steps may be processed in reverse order or simultaneously. Meanwhile, other operations are added to or removed from these processes.
The method for supplying the medicine in the clinical trial of the present invention may be performed by a central stochastic system or may be performed by a separate software and hardware system. The drug delivery system of the clinical trial of the present invention may be contained in the central stochastic system or may be a separate software and hardware system. The independent drug delivery methods and systems are capable of data interaction with a central stochastic system.
Fig. 1 is an exemplary flow chart of a drug delivery method of a clinical trial according to an embodiment of the present invention. Referring to fig. 1, the medicine supplying method of this embodiment includes the steps of:
step S110: extracting a minimum inventory amount of the medication from a supply schedule of the medication, the supply schedule corresponding to a clinical trial center;
step S120: inquiring the current remaining inventory of the medicine in the clinical test center;
step S130: extracting the visit times and visit moments of the subjects from the visit arrangement of the clinical test center, and extracting the dosage of the subjects at each visit from the treatment scheme of the clinical test center, wherein the dosage corresponds to the medicine;
step S140: calculating the medicine demand of the clinical test in a preset time according to the visit times, the visit time, the administration amount and the number of the testees; and
step S150: and calculating the difference between the current remaining inventory amount and the minimum inventory amount, and automatically generating a transfer application form when the difference is less than or equal to the drug demand amount, wherein the transfer application form comprises a first drug transfer amount needing to be transferred.
The above steps S110 to S150 will be described in detail with reference to fig. 2.
In step S110, the supply schedule of the drugs is associated with the specific clinical trial items and the drugs used therein. That is, different drugs, for different clinical trial projects, may have different delivery plans, i.e., different delivery schedules. There may be a plurality of different delivery schedules for the same drug. Step S110 does not limit the number and type of drugs, nor the number of delivery schedules. The supply schedule is typically developed by the researcher of the clinical trial study and provided to a central randomization system. The user of the central stochastic system may select one of the plurality of supply schedules as the supply schedule to be used currently, or may configure a custom supply schedule according to a certain rule.
Fig. 2 is an exemplary block diagram of a drug delivery method of a clinical trial according to an embodiment of the present invention. In the embodiment shown in fig. 2, includes a randomization system 210, a system script 220, and a medication dispenser 230.
Wherein the stochastic system 210 is the central stochastic system described above. The randomization system 210 may be used to manage multiple clinical trial centers. The supply schedule in step S110 corresponds to a certain clinical trial center. The clinical trial center refers to a place where clinical trial projects are performed, including hospitals, research institutions, and the like. For a particular clinical trial, the medication to be used is stored in a medication repository corresponding to the clinical trial center, so that the clinical trial center can dispense the medication to the subject.
The randomization system 210 has a supply schedule of drugs for a plurality of clinical trial centers, names and quantities of drugs stored in drug warehouses, treatment plans of clinical trials at the clinical trial centers, visit schedules, subject information, and the like. At least a minimum inventory of the medication is included in the medication schedule. The randomization system 210 may also provide information on the current remaining inventory of the medication at the clinical trial center, the visit schedule, and the treatment regimen.
The minimum inventory min of the medicine refers to a safe inventory of the medicine in a medicine warehouse of a clinical test center, and the inventory of the medicine is generally larger than the minimum inventory min so as to ensure the smooth progress of the clinical test.
The present invention is not limited to a specific value of the minimum stock quantity min, which is usually a constant.
It is understood that the minimum stock min corresponds to a specific medicine, and different minimum stock min may be set for different medicines, and have different quantization units, such as "branch", "box", "bottle", and the like. Referring to fig. 2, a system script 220 is a main body that performs the medicine supplying method of the present invention. The invention is not limited to the specific implementation of the system script 220. In step S110, the system script 220 extracts a supply schedule of the medicine from the random system 210, and obtains a minimum inventory amount of the medicine. The minimum inventory of the medication may be the subject of input to the system script 220, and the system script 220 determines whether shipping is required based on the input.
In step S120, the system script 220 may query and obtain the current remaining inventory of drugs in the clinical laboratory center from the stochastic system 210. For convenience of later computational expression, the current remaining inventory amount is indicated by the letter "r".
In some embodiments, the initial value of the current remaining inventory amount r may be the first-time-requested amount of the medication. During the clinical trial, the amount of the application is made by each clinical trial center to the drug dispenser 230 according to the schedule of the center. The first filed amount is referred to as a first filed amount, which is the amount of drug stock in the drug warehouse of the clinical trial center. The current remaining inventory r at the clinical trial center is equal to the first request amount when the dispensing of the medication has not started.
In step S130, the visit schedule of the clinical trial center is obtained from the stochastic system 210, from which the number of visits and the visit time of the subject are extracted, and the treatment plan is obtained from the stochastic system 210, from which the administration amount of the subject at each visit is extracted, the administration amount corresponding to the drug.
Step S140 may be performed by the system script 220 to calculate the drug requirement S of the clinical trial within a predetermined time period according to the visit times, the administration amount and the number of the subjects obtained from the stochastic system 210.
The specific calculation method of the required amount S of the medicine is not limited in the invention.
Step S150 may be performed by system script 220 in fig. 2. The system script 220 calculates the difference between the current remaining inventory r and the minimum inventory min, compares the difference with the required quantity S of the drugs, and when r-min is less than or equal to S, indicates that more drugs need to be transported, the system script 220 generates a transfer application form and sends the transfer application form to the drug delivery party 230, wherein the transfer application form comprises the first drug transfer quantity which needs to be transported. If r-min > S, indicating that no drug delivery is required, the system script 220 does not generate a transfer request form.
Step S150 does not limit the specific number of first drug delivery volumes.
In some embodiments, the first drug delivery amount is equal to the drug demand amount S.
In some embodiments, a short-term window is also included in the supply schedule, and the predetermined duration in step S140 is equal to the short-term window. The medicine demand may be calculated according to the following formula in step S140:
ti∈(tnow,tnow+a),i＝1,…,n (2)
in the formula (1), SaIndicates the drug requirement, S, over a short-term windowtiIndicating visit time t at visit number iiThe amount administered, Q, to the subjectiThe number of the testees at visit number i; in the formula (2), tnowDenotes the current time, a denotes the time length of the short-term window, and n is a positive integer. N is a positive integer representing the total number of visits. The short term window represents a safe time window during which the drug may be continuously delivered, and the drug demand calculated from the short term window is the lower limit of the drug demand of the clinical trial center for a period of time in the future.
Equation (2) above describes the visit time tiIs limited from the present moment tnowStarting within a short-term window a. Then the calculated by equation (1) is the drug demand in the future short-term window a. In some embodiments, the first drug delivery amount may be equal to the drug demand amount Sa。
In some embodiments, a long-term window is also included in the supply schedule, the long-term window having a length of time b that is greater than the length of time a of the short-term window. For example, the short-term window has a time length a of 7 days and the long-term window has a time length b of 21 days. When the required amount S of the drug in the short-term window is obtained by calculation according to the above-mentioned formulas (1) and (2)aThereafter, the first drug delivery amount in step S150 may be calculated according to the following formula:
E1＝Sb+min-r (3)
tj∈(tnow,tnow+b),j＝1,…,n (5)
in the formula (3), E1 represents the first drug delivery amount, and min represents the minimum stock amountR represents the current remaining stock quantity, SbIndicating drug demand over a long-term window; in the formula (4), StjIndicating an visit time t at a visit number jjThe amount administered, Q, to the subjectjThe number of the testees at visit time j; in the formula (5), tnowRepresenting the current time of day, and b the length of the long-term window.
The stock amount of the medicine in the medicine warehouse of the clinical trial center can be replenished to the minimum stock amount min + the medicine demand amount S in the long-term window according to the first medicine transporting amount E1 calculated by the above equations (3) to (5)bTo meet the demand of the drug in a long-term window.
According to these embodiments, in step S150, the difference between the current remaining stock amount r and the minimum stock amount min is calculated and compared with the medicine demand S within the short-term windowaComparing, when r-min is less than or equal to SaAutomatically generating a transfer application form, wherein the transfer application form comprises a first medicament transfer amount E1 to be transferred, and the first medicament transfer amount E1 is according to the medicament demand S in a long-term windowbAnd (4) setting.
Referring to fig. 2, the system script 220 sends a transfer request form to the drug delivery party 230, and the drug delivery party 230 performs drug delivery according to the transfer request form to deliver the first drug delivery amount E1 to the drug warehouse of the corresponding clinical testing center.
According to the medicine supply method, the steps S110-S150 can be executed periodically, the transfer application form is triggered in time, and the test medicine is supplemented, so that the problems of waiting of the testee, prolonging of the test process and the like caused by medicine deficiency are solved.
In some embodiments, the drug delivery method of the present invention further comprises a simplified method of calculating the drug delivery amount. In these embodiments, the supply schedule further includes a maximum inventory amount max, and the method further includes: and when the current remaining inventory r is less than or equal to the minimum inventory min, automatically generating a transfer request form, wherein the transfer request form comprises a second drug transfer amount E2 needing to be transferred, the second drug transfer amount E2 is equal to the difference between the maximum inventory max and the current remaining inventory r, and E2 is equal to max-r.
According to these embodiments, it is only necessary to compare the current remaining stock amount r with the minimum stock amount min, and when the current remaining stock amount r is found to be equal to or less than the minimum stock amount min, the second drug transfer amount E2 is applied as max-r, that is, the current stock amount is made up to the maximum stock amount max.
In some embodiments, the drug delivery method of the present invention calculates both the first drug delivery amount E1 and the second drug delivery amount E2, and the method further comprises: comparing the first drug delivery amount E1 with the second drug delivery amount E2, and taking the larger one as the actual drug delivery amount of the transfer application form. According to this embodiment, a larger amount of medication can be transported in one medication transfer, ensuring an adequate supply of medication within the containment range of the medication warehouse.
Fig. 3 is an exemplary flowchart of a drug delivery method of a clinical trial according to another embodiment of the present invention. Referring to fig. 3, the medicine supplying method of this embodiment includes the steps of:
step S310: providing a supply schedule configuration page for the medication, the supply schedule configuration page adapted to configure a minimum inventory amount of the medication;
step S320: providing a central association page, and associating a supply schedule with a clinical test center on the central association page;
step S330: a system script for performing the drug delivery method of steps S110-S150 is provided.
The method of supplying a medicine shown in fig. 3 will be described below with reference to fig. 4 and 5.
Fig. 4 is a schematic diagram of a supply schedule configuration page of a medicine in the medicine supply method according to an embodiment of the present invention. Referring to FIG. 4, the provisioning schedule configuration page 400 provides a provisioning schedule name 410 for configuring a provisioning schedule for which a user may set a unique schedule name.
Referring to FIG. 4, the delivery schedule configuration page 400 also provides configuration tables corresponding to different medications. Including a drug name column 421, an initial value setting column 422, an intelligent plan column 423, and a manual plan column 424. The column corresponding to the drug name column 421 includes names of various drugs and specifications thereof, for example, "aspirin 232_34 tablets/boxes" set in the drug name box 431. The initial value setting column 422 is used to set an initial value of stock corresponding to each drug. As described above, the initial value is the initial value of the current remaining stock amount r, which may be the first-time application amount of the medicine, for example, the initial value set to 7 in the initial value setting block 423, which corresponds to the medicine set in the medicine name block 431.
The intelligent plan column 423 includes 3 columns of content, minimum inventory, short-term window (days), and long-term window (days), respectively. For example, the minimum stock amount is set to 1 box in the minimum stock frame 433, the short-term window is set to 3 days in the short-term window frame 434, and the long-term window is set to 24 days in the long-term window frame 435.
The manual schedule column 424 includes 2 columns of contents, a minimum and a maximum, respectively. For example, the minimum value is set in the minimum value box 436 and the maximum value is set in the maximum value box 437.
In step S310, at least the minimum inventory amount min for the configured medication is included in the supply schedule configuration page 400.
As shown in FIG. 4, in some embodiments, the supply schedule configuration page 400 is further adapted to configure a short-term window and a long-term window, the long-term window having a length of time b that is greater than the length of time a of the short-term window, the system script adapted to calculate a medication demand based on the short-term window and a first medication delivery based on the long-term window.
In these embodiments, the drug demand may be calculated according to the following formula:
ti∈(tnow,tnow+a),i＝1,…,n (7)
wherein S isaIndicates the drug requirement, S, over a short-term windowtiIndicating visit time t at visit number iiThe amount administered, Q, to the subjectiFor visit number iNumber of subjects, tnowDenotes the current time, a denotes the time length of the short-term window, and n is a positive integer.
Equations (6) and (7) are the same as equations (1) and (2), respectively.
In these embodiments, the first drug delivery amount may be calculated according to the following formula:
E1＝Sb+min-r (8)
tj∈(tnow,tnow+b),j＝1,…,n (10)
wherein E1 denotes the first drug shipment volume, min denotes the minimum stock amount, r denotes the current remaining stock amount, SbIndicates the drug requirement, S, over a long-term windowtjIndicating an visit time t at a visit number jjThe amount administered, Q, to the subjectjNumber of subjects at visit number j, tnowRepresenting the current time of day, and b the length of the long-term window.
Equations (8), (9) and (10) are the same as equations (3), (4) and (5), respectively.
In some embodiments, the user may choose to use smart planning, i.e., setting a minimum inventory min, a short-term window, and a long-term window in the supply schedule configuration page 400, and the system script 220 calculates the medication requirement S in the short-term window according to the formula (6-10) in step S330aAnd a first drug delivery amount E1, when r-min is less than or equal to SaWhen the drug delivery amount is larger than the first drug delivery amount E1, the generation of a delivery application form is triggered.
Referring to FIG. 4, in some embodiments, where the provisioning schedule configuration page 400 is further adapted to configure a maximum inventory amount max, the system script 220 is further adapted to perform the following steps: when the current remaining stock amount r is less than or equal to the minimum stock amount min, a transfer request form is automatically generated, the transfer request form includes a second drug transfer amount E2 to be transferred, and the second drug transfer amount E2 is equal to the difference between the maximum stock amount max and the current remaining stock amount r.
Referring to FIG. 4, below the manual schedule column 424, a minimum value and a maximum value may be set. The minimum value is the minimum stock quantity min and the maximum value is the maximum stock quantity max.
In some embodiments, the user may choose to use manual planning, that is, only setting the minimum inventory amount min and the maximum value max in the supply schedule configuration page 400, and in step S330, the system script 220 compares the current remaining inventory amount r with the minimum inventory amount min, and when r is less than or equal to min, automatically generates a transfer application form with the transfer amount of the second drug transfer amount E2 being max-r.
In some embodiments, the user may select both the smart plan and the manual plan, i.e., set the minimum inventory amount min, the short term window, the long term window, and the maximum inventory amount max in the supply schedule configuration page 400. In these embodiments, the system script 220 will calculate the first medication delivery amount E1 and the second medication delivery amount E2, and will also perform the following steps: comparing the first drug delivery amount E1 with the second drug delivery amount E2, and taking the larger one as the actual drug delivery amount of the transfer application form.
As shown in fig. 4, a shipping setting item 425 is also included in the supply schedule configuration page 400 for setting the number of days undeliverable and the number of days to disregard inventory for each medication, for example, the number of days to undeliverable is set in the undeliverable box 438 and the number of days to disregard inventory is set in the disregard inventory 439. The number of undeliverable days refers to the number of remaining days of the medicament from the validity period and cannot be initiated to be transported, for the medicament stored in the medicament delivery party; the number of days without inventory is for an inventory of medication in a clinical trial center, meaning how many days the medication remains from the expiration date cannot be accounted for in inventory. For a particular clinical trial, a requirement for the number of days remaining for a drug from the expiration date may be set by the number of days non-shippable and the number of days out of inventory in the supply schedule configuration page 400. The drug that is deemed not to be deliverable according to the set conditions is not transported, is deemed to be out of stock, and is not accounted for when calculating the current remaining stock r. By setting the number of days of non-delivery and the number of days of inventory disregarding, it is ensured that the number of active drugs in inventory is maintained at a safe amount.
Fig. 5 is a schematic diagram of a center association page in the medication supply method according to an embodiment of the present invention. Referring to FIG. 5, the center association page 500 includes a center name option 510, a supply plan option 520. The hub name option 510 may provide a drop-down menu including the names of all clinical trial hubs involved in the clinical trial, from which the user may select the hub name to be associated. The delivery plan option 520 may provide a drop-down menu that includes the plan names of all delivery schedules involved in the clinical trial, from which the user may select the plan names. The plan name includes the plan name configured in the supply schedule configuration page 400 shown in fig. 4. After the setup is completed, the user can establish the set association relationship between the clinical trial center and the drug delivery plan by clicking the application button 550.
Referring to fig. 5, in some embodiments, the central association page 500 further includes an association library option 530, which may provide a pull-down menu, where the pull-down menu includes all libraries corresponding to the clinical trial center, and a user may select one of the libraries as a recipient of the transfer application form.
As illustrated with reference to FIG. 5, in some embodiments, an auto-runtime settings item 540 is also included in the hub association page 500. The user can set the runtime of the system script in the auto runtime setting item 540, so that the system script automatically runs according to a set rule, for example, 8 am each day.
In step S330, with reference to FIG. 2, the system script 220 executes steps S110-S150, and may trigger generation of a transfer request form when r-min is less than or equal to S. The above description about fig. 2 can be used to describe the step S330. In connection with various embodiments, the system script 220 performs various embodiments based on the results of the settings of the provisioning schedule configuration page 400 and the center association page 500.
Fig. 6 is a schematic diagram of an waybill inquiry page in the medication supply method according to an embodiment of the present invention. Referring to FIG. 6, in some embodiments, system script 220, after generating the diversion application form, also provides an invoice query page 600. The waybill query page 600 includes, but is not limited to, waybill number 611, waybill status 612, medication composition 613, transferee 614, transferee 615, application date 616, and applicant 617. The actual execution situation of the transfer application form can be known according to the waybill inquiry page 600.
According to the medicine supply method shown in fig. 3-6, a user can flexibly configure the supply schedule configuration page and the center association page of the medicine, the system script executes the medicine supply according to the configuration of the user, and the generation of a medicine transportation application form is triggered once the medicine needs to be supplemented, so as to timely carry out the medicine delivery to the clinical test center, thereby avoiding various problems caused by the shortage of the medicine.
The invention also includes a clinical trial drug delivery system including a memory and a processor. Wherein the memory is to store instructions executable by the processor; the processor is configured to execute the instructions to implement the method of drug delivery for a clinical trial as described above.
Fig. 7 is a system block diagram of a drug delivery system for a clinical trial according to an embodiment of the present invention. Referring to fig. 7, the drug delivery system 700 may include an internal communication bus 701, a processor 702, a Read Only Memory (ROM)703, a Random Access Memory (RAM)704, and a communication port 705. When implemented on a personal computer, the medication supply system 700 may also include a hard disk 706. An internal communication bus 701 may enable data communication between the components of the medication supply system 700. The processor 702 may make the determination and issue the prompt. In some embodiments, the processor 702 may be comprised of one or more processors. The communication port 705 may enable data communication of the drug supply system 700 with the outside. In some embodiments, the medication supply system 700 may send and receive information and data from a network through the communication port 705. The drug delivery system 700 may also comprise various forms of program storage units and data storage units, such as a hard disk 706, Read Only Memory (ROM)703 and Random Access Memory (RAM)704, capable of storing various data files for computer processing and/or communication use, as well as possible program instructions for execution by the processor 702. The processor executes these instructions to implement the main parts of the method. The results processed by the processor are communicated to the user device through the communication port and displayed on the user interface.
The medication delivery method described above may be implemented as a computer program, stored on the hard disk 706, and loaded into the processor 702 for execution to implement the medication delivery method of the present application.
The invention also comprises a computer readable medium having stored thereon computer program code which, when executed by a processor, implements the method of drug delivery for a clinical trial as described above.
The method of providing a drug for clinical trials, when embodied as a computer program, may also be stored as an article of manufacture in a computer readable storage medium. For example, computer-readable storage media can include but are not limited to magnetic storage devices (e.g., hard disk, floppy disk, magnetic strips), optical disks (e.g., Compact Disk (CD), Digital Versatile Disk (DVD)), smart cards, and flash memory devices (e.g., electrically Erasable Programmable Read Only Memory (EPROM), card, stick, key drive). In addition, various storage media described herein can represent one or more devices and/or other machine-readable media for storing information. The term "machine-readable medium" can include, without being limited to, wireless channels and various other media (and/or storage media) capable of storing, containing, and/or carrying code and/or instructions and/or data.
It should be understood that the above-described embodiments are illustrative only. The embodiments described herein may be implemented in hardware, software, firmware, middleware, microcode, or any combination thereof. For a hardware implementation, the processor may be implemented within one or more Application Specific Integrated Circuits (ASICs), Digital Signal Processors (DSPs), Digital Signal Processing Devices (DSPDs), Programmable Logic Devices (PLDs), Field Programmable Gate Arrays (FPGAs), processors, controllers, micro-controllers, microprocessors, and/or other electronic units designed to perform the functions described herein, or a combination thereof.
Aspects of the present application may be embodied entirely in hardware, entirely in software (including firmware, resident software, micro-code, etc.) or in a combination of hardware and software. The above hardware or software may be referred to as "data block," module, "" engine, "" unit, "" component, "or" system. The processor may be one or more Application Specific Integrated Circuits (ASICs), Digital Signal Processors (DSPs), digital signal processing devices (DAPDs), Programmable Logic Devices (PLDs), Field Programmable Gate Arrays (FPGAs), processors, controllers, microcontrollers, microprocessors, or a combination thereof. Furthermore, aspects of the present application may be represented as a computer product, including computer readable program code, embodied in one or more computer readable media. For example, computer-readable media may include, but are not limited to, magnetic storage devices (e.g., hard disk, floppy disk, magnetic strips … …), optical disks (e.g., Compact Disk (CD), Digital Versatile Disk (DVD) … …), smart cards, and flash memory devices (e.g., card, stick, key drive … …).
The computer readable medium may comprise a propagated data signal with the computer program code embodied therein, for example, on a baseband or as part of a carrier wave. The propagated signal may take any of a variety of forms, including electromagnetic, optical, and the like, or any suitable combination. The computer readable medium can be any computer readable medium that can communicate, propagate, or transport the program for use by or in connection with an instruction execution system, apparatus, or device. Program code on a computer readable medium may be propagated over any suitable medium, including radio, electrical cable, fiber optic cable, radio frequency signals, or the like, or any combination of the preceding.
Having thus described the basic concept, it will be apparent to those skilled in the art that the foregoing disclosure is by way of example only, and is not intended to limit the present application. Various modifications, improvements and adaptations to the present application may occur to those skilled in the art, although not explicitly described herein. Such modifications, improvements and adaptations are proposed in the present application and thus fall within the spirit and scope of the exemplary embodiments of the present application.
Also, this application uses specific language to describe embodiments of the application. Reference throughout this specification to "one embodiment," "an embodiment," and/or "some embodiments" means that a particular feature, structure, or characteristic described in connection with at least one embodiment of the present application is included in at least one embodiment of the present application. Therefore, it is emphasized and should be appreciated that two or more references to "an embodiment" or "one embodiment" or "an alternative embodiment" in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, some features, structures, or characteristics of one or more embodiments of the present application may be combined as appropriate.
Numerals describing the number of components, attributes, etc. are used in some embodiments, it being understood that such numerals used in the description of the embodiments are modified in some instances by the use of the modifier "about", "approximately" or "substantially". Unless otherwise indicated, "about", "approximately" or "substantially" indicates that the number allows a variation of ± 20%. Accordingly, in some embodiments, the numerical parameters used in the specification and claims are approximations that may vary depending upon the desired properties of the individual embodiments. In some embodiments, the numerical parameter should take into account the specified significant digits and employ a general digit preserving approach. Notwithstanding that the numerical ranges and parameters setting forth the broad scope of the range are approximations, in the specific examples, such numerical values are set forth as precisely as possible within the scope of the application.
Claims (14)
1. A method of providing a medication for a clinical trial, comprising:
extracting a minimum inventory amount of a medication from a supply schedule for the medication, the supply schedule corresponding to a clinical trial center;
inquiring the current remaining inventory of the medicine in the clinical test center;
extracting the visit times and visit moments of the subjects from the visit arrangement of the clinical test center, and extracting the dosage of the subjects at each visit from the treatment scheme of the clinical test center, wherein the dosage corresponds to the medicine;
calculating the medicine demand of the clinical test in a preset time according to the visit times, the administration amount at the visit time and the number of the testees; and
and calculating the difference between the current remaining inventory amount and the minimum inventory amount, and automatically generating a transfer application form when the difference is less than or equal to the drug demand amount, wherein the transfer application form comprises a first drug transfer amount needing to be transferred.
2. The medication supply method of claim 1, wherein said first medication delivery amount is equal to said medication demand amount.
3. The medication delivery method of claim 1, further comprising extracting a short term window from said delivery schedule, said predetermined duration being equal to said short term window, and calculating said medication demand according to the following formula:
ti∈(tnow，tnow+a)，i＝1，…，n
wherein S isaRepresenting the drug requirement, S, over the short-term windowtiIndicating visit time t at visit number iiAn amount of drug administered, Q, to the subjectiNumber of subjects at visit number i, tnowRepresenting the current time, a representing the time length of the short-term window, and n being a positive integer.
4. A medication delivery method according to claim 3, further comprising extracting a long-term window from said delivery schedule, said long-term window having a length of time greater than a length of time of said short-term window, said first medication delivery volume being calculated according to the following formula:
E＝Sb+min-r
tj∈(tnow，tnow+b),j＝1,…，n
wherein E represents the first medicine transporting amount, min represents the minimum stock amount, r represents the current remaining stock amount, SbIndicating the drug requirement, S, over the long-term windowtjIndicating an visit time t at a visit number jjAn amount of drug administered, Q, to the subjectjNumber of subjects at visit number j, tnowRepresenting the current time instant, b representing the time length of the long-term window.
5. The medication delivery method of claim 1, further comprising extracting a maximum inventory amount from said delivery schedule, said method further comprising: and when the current remaining inventory amount is less than or equal to the minimum inventory amount, automatically generating the transfer request form, wherein the transfer request form comprises a second drug transfer amount to be transferred, and the second drug loading amount is equal to the difference value between the maximum inventory amount and the current remaining inventory amount.
6. The medication supply method of claim 5, further comprising: comparing the first drug delivery amount and the second drug delivery amount, and taking the larger of the first drug delivery amount and the second drug delivery amount as the actual drug delivery amount of the transfer application form.
7. A method of providing a medication for a clinical trial, comprising:
providing a supply schedule configuration page for a medication, the supply schedule configuration page adapted to configure a minimum inventory amount of the medication;
providing a center association page, and associating a supply schedule with a clinical trial center on the center association page; and
providing a system script for performing the method of drug provisioning according to any of claims 1-2.
8. The medication delivery method of claim 7, wherein the delivery schedule configuration page is further adapted to configure a short-term window and a long-term window, the long-term window having a length of time greater than the length of time of the short-term window, the system script adapted to calculate the medication demand based on the short-term window and the first medication delivery based on the long-term window.
9. The medication supply method of claim 8, wherein said medication demand is calculated according to the following formula:
ti∈(tnow，tnow+a)，i＝1，…，n
wherein S isaRepresenting the drug requirement, S, over the short-term windowtiIndicating visit time t at visit number iiAn amount of drug administered, Q, to the subjectiNumber of subjects at visit number i, tnowRepresenting the current time, a representing the time length of the short-term window, and n being a positive integer.
10. The drug supply method according to claim 8, wherein the first drug delivery amount is calculated according to the following formula:
E1＝Sb+min-r
tj∈(tnow,tnow+b),j＝1,…，n
wherein E1 represents the first drug delivery amount, min represents the minimum stock quantity, r represents the current remaining stock quantity, SbIndicating the drug requirement, S, over the long-term windowtjIndicating an visit time t at a visit number jjAn amount of drug administered, Q, to the subjectjNumber of subjects at visit number j, tnowRepresenting the current time instant, b representing the time length of the long-term window.
11. The medication delivery method of claim 7, wherein said delivery schedule configuration page is further adapted to configure a maximum inventory amount, said system script further adapted to perform the steps of:
and when the current remaining inventory amount is less than or equal to the minimum inventory amount, automatically generating the transfer request form, wherein the transfer request form comprises a second drug transfer amount to be transferred, and the second drug loading amount is equal to the difference value between the maximum inventory amount and the current remaining inventory amount.
12. The medication delivery method of claim 11, wherein the system script is further adapted to perform the steps of: comparing the first drug delivery amount and the second drug delivery amount, and taking the larger of the first drug delivery amount and the second drug delivery amount as the actual drug delivery amount of the transfer application form.
13. A clinical trial drug delivery system comprising:
a memory for storing instructions executable by the processor;
a processor for executing the instructions to implement the method of any one of claims 1-12.
14. A computer-readable medium having stored thereon computer program code which, when executed by a processor, implements the method of any of claims 1-12.
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