Intelligent quality control system and method for clinical research

Abstract

The invention discloses an intelligent quality control system and method for clinical research, and belongs to the technical field of clinical research. A statistical unit; based on the medicine evaluation model of the curative effect grade, performing subject medication analysis, calculating a corrected curative effect coefficient i, according to the curative effect grade setting condition based on age, performing subject curative effect grade judgment, and generating a medicine effect evaluation report; and the medicine adjusting module is used for adjusting the dosage of the subject in the next stage according to the curative effect grade of the subject and carrying out medicine stopping treatment when the subject is in the non-effective grade in three continuous stages. Through the mode, a subject can timely and clearly know the current individual curative effect condition, and the confidence and subsequent compliance of the subject can be improved; the dosage of the subject in the next stage can be intelligently adjusted in time according to the curative effect grade of the subject, and the subject is guided to stop medicine reasonably in time.

Description

Technical Field

[0001] The present invention relates to the technical field of clinical research, and in particular to an intelligent quality control system and method for clinical research. Background Art

[0002] Drug clinical research refers to scientific research that uses patients or healthy people as research subjects to reveal the tolerance, safety, and pharmacokinetics of new drugs in the human body.

[0003] During the clinical trial, the quality control of the subject data is required to ensure the overall accuracy of the drug clinical research. Currently, there are few studies on the efficacy evaluation of subjects at each stage, and it is difficult for subjects to know their current efficacy in a timely and clear manner, which also has a certain impact on the confidence and subsequent compliance of the subjects. At the same time, R&D personnel are currently required to adjust the dosage of the drug, and it is difficult to intelligently adjust and guide the subjects to take the drug according to the drug effect (such as deterioration, the effect is not obvious for many times), and guide the subjects to stop the drug reasonably.

[0004] Based on this, the present invention designs a clinical research intelligent quality control system and method thereof to solve the above problems. Summary of the invention

[0005] In view of the above-mentioned shortcomings of the prior art, the present invention provides a clinical research intelligent quality control system and method thereof.

[0006] To achieve the above objectives, the present invention is implemented through the following technical solutions:

[0007] An intelligent quality control system for clinical research, comprising:

[0008] The subject data collection unit collects the biochemical test parameter values ​​M of the subjects at each medication stage. 1-n , the subject's weight m, age b, current medication dosage E 1-n and transmit the data to the statistical unit;

[0009] The statistical unit calculates the mean drug dosage e based on the current drug dosage in each stage:

[0010] e=(E1+E2……+E n ) / n

[0011] Among them, E1 represents the dosage in the initial stage, E2 represents the dosage in the second stage, and E n Indicates the dosage of the current final stage, and n represents the number of stages that have been completed;

[0012] And the mean value of drug dosage e, biochemical test parameter value M 1-n , the subject's weight m, age b, current medication dosage E1-n The data is bound and stored with the corresponding subject information;

[0013] Based on the drug evaluation model of efficacy level, the drug use analysis of the subjects is carried out to calculate the biochemical test parameter value M within the set time range. 1-n The efficacy coefficient a and the dosage K per unit body weight of the subject are used to calculate the modified efficacy coefficient i; according to the age-based efficacy level setting conditions, the efficacy level of the subject is judged and a drug effect evaluation report is generated;

[0014] Evaluation report output unit, generating drug effect evaluation report;

[0015] The drug adjustment module adjusts the drug dosage of the subject in the next stage according to the efficacy level of the subject. n+1 , and when the subject is in the ineffective level for three consecutive stages, adjust the subject's medication dose for the next stage E n+1 =0, stop the medication.

[0016] Furthermore, the drug evaluation model based on efficacy level includes:

[0017] The stage setting module sets the value of the number of stages n' that fall within the evaluation time range, 1<n'≤n, when n'=n, it means that all the currently completed stages fall within the evaluation time range, when n'<n, the nth stage and the remaining n-1 stages except the initial stage are randomly selected to fall within the evaluation time range;

[0018] The subject medication analysis module calculates the biochemical test parameter value M within the set time range 1-n’ The efficacy coefficient a is:

[0019] (1) When n'=n, a=(M2 / M1+M3 / M2+...M n / M n-1 ) / (n-1);

[0020] (2) When n'<n, a=(M 2’ / M 1’ +M 3’ / M 2’ +......M n’ / M n’-1 ) / (n'-1);

[0021] Among them, M2' represents the biochemical test parameter value corresponding to the first stage of random selection, M 1’ represents the biochemical test parameter value corresponding to the previous stage of the first randomly selected stage; M n’ represents the biochemical test parameter value corresponding to the randomly selected n'th stage, Mn’-1 represents the biochemical test parameter value corresponding to the previous stage of the randomly selected n'th stage;

[0022] Calculate the drug dosage K per unit body weight of the subject:

[0023] K=e / m

[0024] Among them, e represents the mean dosage, and m represents the weight of the subject;

[0025] Calculate the modified efficacy coefficient i:

[0026] i=K*a*10 5

[0027] The subject efficacy level judgment module inputs the efficacy coefficient i and sets conditions based on the age-based efficacy level to judge the subject's efficacy level.

[0028] Furthermore, the age-based efficacy level setting conditions are:

[0029] The drug is ineffective for the subject: i<2.06eb / 300;

[0030] The drug has a general effect on the subjects: 2.06eb / 300≤i<2.14eb / 300;

[0031] The drug is effective for the subject: i≥2.14eb / 300.

[0032] Furthermore, the drug adjustment module includes:

[0033] The dosage adjustment unit adjusts the dosage of the subject in the next stage according to the efficacy level of the subject. n+1 ;

[0034] Invalid: E n+1 =1.3~1.5E n ;

[0035] General: E n+1 =1.1~1.3E n ;

[0036] Valid: E n+1 =E n ;

[0037] The efficacy statistics unit is used to record the class value of the efficacy level of the subjects. The class value of valid records is set to 0, and the class value of invalid and general records is set to 1. The sum p of the efficacy levels of the current completed stage and the previous two stages is calculated.

[0038] Furthermore, the drug adjustment module also includes a risk judgment unit to judge whether p is less than 3; if so, the drug dosage of the subject in the next stage is E n+1 , the clinical study continues; if not, output E n+1 =0, the clinical study of the subject is completed and the drug discontinuation treatment is carried out; and the drug dosage adjustment result and the drug discontinuation treatment information are sent to the evaluation report output unit.

[0039] Furthermore, the drug effect evaluation report includes at least the subject's personal information, the biochemical test parameter values ​​M of the subject at each medication stage, and the 1-n , the subject's weight m, age b, current medication dosage E 1-n data, the mean dosage e calculated for the current stage dosage, the number of stages n' falling within the evaluation time range, the modified efficacy coefficient i and the subject efficacy level, as well as instructions for adjusting the drug dosage when the subject is in a non-effective level, and instructions for stopping the drug when the subject is in a non-effective level for three consecutive stages.

[0040] A control method for a clinical research intelligent quality control system comprises the following steps:

[0041] 1. Collect the biochemical test parameter values ​​M of the subjects at each medication stage 1-n , the subject's weight m, age b, current medication dosage E 1-n data;

[0042] 2. Calculate the mean dosage e based on the current dosage in each stage:

[0043] e=(E1+E2……+E n ) / n

[0044] Among them, E1 represents the dosage in the initial stage, E2 represents the dosage in the second stage, and E n Indicates the dosage of the current final stage, and n represents the number of stages that have been completed;

[0045] And the mean value of drug dosage e, biochemical test parameter value M 1-n , the subject's weight m, age b, current medication dosage E 1-n The data is bound and stored with the corresponding subject information;

[0046] 3. Conduct drug analysis on subjects and calculate the biochemical test parameter value M within the set time range 1-n The efficacy coefficient a and the dosage K per unit body weight of the subject are used to calculate the modified efficacy coefficient i; according to the age-based efficacy level setting conditions, the efficacy level of the subject is judged and a drug effect evaluation report is generated;

[0047] 4. According to the subject's efficacy level, adjust the subject's medication dosage for the next stage E n+1 , and when the subject is in the ineffective level for three consecutive stages, adjust the subject's medication dose for the next stage E n+1 =0, stop the drug;

[0048] 5. Generate a drug effect evaluation report; the drug effect evaluation report shall at least include the subject's personal information, the biochemical test parameter values ​​of the subject at each medication stage, and 1-n , the subject's weight m, age b, current medication dosage E 1-n data, the mean dosage e calculated for the current stage dosage, the number of stages n' falling within the evaluation time range, the modified efficacy coefficient i and the subject efficacy level, as well as instructions for adjusting the drug dosage when the subject is in a non-effective level, and instructions for stopping the drug when the subject is in a non-effective level for three consecutive stages.

[0049] Furthermore, step three includes:

[0050] 3.1 Set the value of the number of stages n' that fall within the evaluation time range, 1<n'≤n, when n'=n, it means that all the currently completed stages fall within the evaluation time range, when n'<n, select the nth stage and randomly select the remaining n-1 stages except the initial stage to fall within the evaluation time range;

[0051] 3.2 Calculate the biochemical test parameter value M within the set time range 1-n’ The efficacy coefficient a is:

[0052] (1) When n'=n, a=(M2 / M1+M3 / M2+...M n / M n-1 ) / (n-1);

[0053] (2) When n'<n, a=(M 2’ / M 1’ +M 3’ / M 2’ +......M n’ / M n’-1 ) / (n'-1);

[0054] Among them, M2' represents the biochemical test parameter value corresponding to the first stage of random selection, M 1’ represents the biochemical test parameter value corresponding to the previous stage of the first randomly selected stage; M n’ represents the biochemical test parameter value corresponding to the randomly selected n'th stage, M n’-1 represents the biochemical test parameter value corresponding to the previous stage of the randomly selected n'th stage;

[0055] 3.3 Calculate the dosage K per unit body weight of the subject:

[0056] K=e / m

[0057] Among them, e represents the mean dosage, and m represents the weight of the subject;

[0058] 3.4 Calculate the modified efficacy coefficient i:

[0059] i=K*a*10 5

[0060] 3.5 Input the efficacy coefficient i and set the conditions based on the efficacy level of the age to determine the efficacy level of the subject.

[0061] Furthermore, the age-based efficacy level setting conditions are:

[0062] The drug is ineffective for the subject: i<2.06eb / 300;

[0063] The drug has a general effect on the subjects: 2.06eb / 300≤i<2.14eb / 300;

[0064] The drug is effective for the subject: i≥2.14eb / 300.

[0065] Furthermore, step four includes:

[0066] 4.1 According to the subject's efficacy level, adjust the subject's medication dosage for the next stage E n+1 ;

[0067] Invalid: E n+1 =1.3~1.5E n ;

[0068] General: E n+1 =1.1~1.3E n ;

[0069] Valid: E n+1 =E n ;

[0070] 4.2 Record the class value of the efficacy level of the subject, set the class value of the effective record to 0, and the class value of the invalid and general record to 1, and calculate the sum of the efficacy levels of the current completed stage and the previous two stages, p;

[0071] 4.3 Determine whether p is less than 3; if so, the dose of the subject in the next stage is E n+1 , the clinical study continues; if not, output E n+1=0, the clinical study of the subject is completed and the drug discontinuation treatment is carried out; and the drug dosage adjustment result and the drug discontinuation treatment information are sent to the evaluation report output unit.

[0072] Beneficial Effects

[0073] The present invention can enable the subjects to know their current efficacy status in a timely and clear manner, which is conducive to the subjects knowing their personal status in a transparent, quantitative and intuitive manner during the clinical research process, and is conducive to improving the subjects' confidence and subsequent compliance;

[0074] The present invention can timely and intelligently adjust the subject's medication dosage for the next stage according to the subject's efficacy level. At the same time, when the subject is at an ineffective level for three consecutive stages, the subject can be guided to stop the medication in a timely manner to avoid further deterioration of the subject's condition or general effect affecting the subject's treatment effect. BRIEF DESCRIPTION OF THE DRAWINGS

[0075] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments or the prior art descriptions are briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention, and for ordinary technicians in this field, other drawings can be obtained based on these drawings without creative work.

[0076] Figure 1 It is an overall block diagram of a clinical research intelligent quality control system of the present invention;

[0077] Figure 2 It is a principle block diagram of the drug evaluation model based on efficacy level in the present invention;

[0078] Figure 3 It is a principle block diagram of the statistical unit in the present invention;

[0079] Figure 4 A flowchart of an intelligent quality control method for clinical research according to the present invention;

[0080] Figure 5 This is a flow chart of the method for analyzing drug use of subjects in the present invention;

[0081] Figure 6 It is a schematic diagram of the drug effect evaluation report of the present invention. DETAILED DESCRIPTION

[0082] In order to make the purpose, technical solution and advantages of the embodiments of the present invention clearer, the technical solution in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0083] The present invention will be further described below in conjunction with the embodiments.

[0084] Example 1

[0085] Please refer to the instruction manual Figure 1 , an intelligent quality control system for clinical research, comprising:

[0086] The subject data collection unit collects the biochemical test parameter values ​​M of the subjects at each medication stage. 1-n , the subject's weight m, age b, current medication dosage E 1-n and transmit the data to the statistical unit;

[0087] The statistical unit calculates the mean drug dosage e based on the current drug dosage in each stage:

[0088] e=(E1+E2……+E n ) / n

[0089] Among them, E1 represents the dosage in the initial stage, E2 represents the dosage in the second stage, and E n Indicates the dosage of the current final stage, and n represents the number of stages that have been completed;

[0090] And the mean value of drug dosage e, biochemical test parameter value M 1-n , the subject's weight m (in g), age b (in years), and the current dosage E of each stage 1-n The data (unit g) is bound and stored with the corresponding subject information;

[0091] Based on the drug evaluation model of efficacy level, the drug use analysis of the subjects is carried out to calculate the biochemical test parameter value M within the set time range. 1-n The efficacy coefficient a and the dosage K per unit body weight of the subject are used to calculate the modified efficacy coefficient i; according to the age-based efficacy level setting conditions, the efficacy level of the subject is judged and a drug effect evaluation report is generated;

[0092] Please refer to the instruction manual Figure 2 , a drug evaluation model based on efficacy level, including:

[0093] The stage setting module sets the value of the number of stages n' that fall within the evaluation time range, 1<n'≤n, when n'=n, it means that all the currently completed stages fall within the evaluation time range, when n'<n, the nth stage and the remaining n-1 stages except the initial stage are randomly selected to fall within the evaluation time range;

[0094] The subject medication analysis module calculates the biochemical test parameter value M within the set time range 1-n’ The efficacy coefficient a is:

[0095] (1) When n'=n, a=(M2 / M1+M3 / M2+...M n / M n-1 ) / (n-1);

[0096] (2) When n'<n, a=(M 2’ / M 1’ +M 3’ / M 2’ +......M n’ / M n’-1 ) / (n'-1);

[0097] Among them, M2' represents the biochemical test parameter value corresponding to the first stage of random selection, M 1’ represents the biochemical test parameter value corresponding to the previous stage of the first randomly selected stage; M n’ represents the biochemical test parameter value corresponding to the randomly selected n'th stage, M n’-1 represents the biochemical test parameter value corresponding to the previous stage of the randomly selected n'th stage;

[0098] Calculate the drug dosage K per unit body weight of the subject:

[0099] K=e / m

[0100] Among them, e represents the mean dosage, and m represents the weight of the subject;

[0101] Calculate the modified efficacy coefficient i:

[0102] i=K*a*10 5

[0103] The subject efficacy level judgment module inputs the efficacy coefficient i and judges the subject efficacy level based on the age-based efficacy level setting conditions;

[0104] The age-based efficacy ratings were set as follows:

[0105] The drug is ineffective for the subject: i<2.06eb / 300;

[0106] The drug has a general effect on the subjects: 2.06eb / 300≤i<2.14eb / 300;

[0107] The drug is effective for the subject: i≥2.14eb / 300;

[0108] The evaluation report output unit generates a drug effect evaluation report; the drug effect evaluation report includes at least the subject's personal information, the biochemical test parameter values ​​M of the subject at each medication stage 1-n , the subject's weight m, age b, current medication dosage E 1-n data, the mean dosage e calculated for the current dosage of each stage, the number of stages n' falling within the evaluation time range, the modified efficacy coefficient i and the subject's efficacy level, as well as instructions for adjusting the dosage of the drug when the subject is in a non-effective level, and instructions for stopping the drug when the subject is in a non-effective level for three consecutive stages;

[0109] The present invention can enable the subjects to know their current efficacy status in a timely and clear manner, which is conducive to the subjects knowing their personal status in a transparent, quantitative and intuitive manner during the clinical research process, and is conducive to improving the subjects' confidence and subsequent compliance;

[0110] The drug adjustment module adjusts the drug dosage of the subject in the next stage according to the efficacy level of the subject. n+1 , and when the subject is in the ineffective level for three consecutive stages, adjust the subject's medication dose for the next stage E n+1 =0, stop the drug;

[0111] Specifically, the medication adjustment module includes:

[0112] The dosage adjustment unit adjusts the dosage of the subject in the next stage according to the efficacy level of the subject. n+1 ;

[0113] Invalid: E n+1 =1.3~1.5E n ;

[0114] General: E n+1 =1.1~1.3E n ;

[0115] Valid: E n+1 =E n ;

[0116] The efficacy statistics unit is used to record the class value of the efficacy level of the subject, the class value of the effective record is set to 0, the class value of the invalid and general record is set to 1, and the sum p of the efficacy levels of the current completed stage and the previous two stages is calculated;

[0117] The risk judgment unit determines whether p is less than 3; if so, the drug dosage of the subject in the next stage is E n+1 , the clinical study continues; if not, output E n+1 =0, the clinical study of the subject is ended, and the drug discontinuation treatment is carried out; and the drug dosage adjustment result and the drug discontinuation treatment information are sent to the evaluation report output unit;

[0118] The present invention can timely and intelligently adjust the subject's medication dosage for the next stage according to the subject's efficacy level. At the same time, when the subject is at an ineffective level for three consecutive stages, the subject can be guided to stop the medication in a timely manner to avoid further deterioration of the subject's condition or general effect affecting the subject's treatment effect.

[0119] Example 2

[0120] Please refer to the instruction manual Figure 4-6 , a clinical research intelligent quality control method, comprising the following steps:

[0121] 1. Collect the biochemical test parameter values ​​M of the subjects at each medication stage 1-n , the subject's weight m, age b, current medication dosage E 1-n data;

[0122] 2. Calculate the mean dosage e based on the current dosage in each stage:

[0123] e=(E1+E2……+E n ) / n

[0124] Among them, E1 represents the dosage in the initial stage, E2 represents the dosage in the second stage, and E n Indicates the dosage of the current final stage, and n represents the number of stages that have been completed;

[0125] And the mean value of drug dosage e, biochemical test parameter value M 1-n , the subject's weight m, age b, current medication dosage E 1-n The data is bound and stored with the corresponding subject information;

[0126] 3. Conduct drug analysis on subjects and calculate the biochemical test parameter value M within the set time range 1-n The efficacy coefficient a and the dosage K per unit body weight of the subject are used to calculate the modified efficacy coefficient i; according to the age-based efficacy level setting conditions, the efficacy level of the subject is judged and a drug effect evaluation report is generated;

[0127] Specifically, step three includes:

[0128] 3.1 Set the value of the number of stages n' that fall within the evaluation time range, 1<n'≤n, when n'=n, it means that all the currently completed stages fall within the evaluation time range, when n'<n, select the nth stage and randomly select the remaining n-1 stages except the initial stage to fall within the evaluation time range;

[0129] 3.2 Calculate the biochemical test parameter value M within the set time range 1-n’ The efficacy coefficient a is:

[0130] (1) When n'=n, a=(M2 / M1+M3 / M2+...M n / M n-1 ) / (n-1);

[0131] (2) When n'<n, a=(M 2’ / M 1’ +M 3’ / M 2’ +......M n’ / M n’-1 ) / (n'-1);

[0132] Among them, M2' represents the biochemical test parameter value corresponding to the first stage of random selection, M 1’ represents the biochemical test parameter value corresponding to the previous stage of the first randomly selected stage; M n’ represents the biochemical test parameter value corresponding to the randomly selected n'th stage, M n’-1 represents the biochemical test parameter value corresponding to the previous stage of the randomly selected n'th stage;

[0133] 3.3 Calculate the dosage K per unit body weight of the subject:

[0134] K=e / m

[0135] Among them, e represents the mean dosage, and m represents the weight of the subject;

[0136] 3.4 Calculate the modified efficacy coefficient i:

[0137] i=K*a*10 5

[0138] 3.5 Input the efficacy coefficient i and set the conditions based on the efficacy level of the age to determine the efficacy level of the subject;

[0139] The age-based efficacy ratings were set as follows:

[0140] The drug is ineffective for the subject: i<2.06eb / 300;

[0141] The drug has a general effect on the subjects: 2.06eb / 300≤i<2.14eb / 300;

[0142] The drug is effective for the subject: i≥2.14eb / 300;

[0143] 4. According to the subject's efficacy level, adjust the subject's medication dosage for the next stage E n+1 , and when the subject is in the ineffective level for three consecutive stages, adjust the subject's medication dose for the next stage E n+1 =0, stop the drug;

[0144] Specifically, step four includes:

[0145] 4.1 According to the subject's efficacy level, adjust the subject's medication dosage for the next stage E n+1 ;

[0146] Invalid: E n+1 =1.3~1.5E n ;

[0147] General: E n+1 =1.1~1.3E n ;

[0148] Valid: E n+1 =E n ;

[0149] 4.2 Record the class value of the efficacy level of the subject, set the class value of the effective record to 0, and the class value of the invalid and general record to 1, and calculate the sum of the efficacy levels of the current completed stage and the previous two stages, p;

[0150] 4.3 Determine whether p is less than 3; if so, the dose of the subject in the next stage is E n+1 , the clinical study continues; if not, output E n+1 =0, the clinical study of the subject is ended, and the drug discontinuation treatment is carried out; and the drug dosage adjustment result and the drug discontinuation treatment information are sent to the evaluation report output unit;

[0151] 5. Generate a drug effect evaluation report; the drug effect evaluation report shall at least include the subject's personal information, the biochemical test parameter values ​​of the subject at each medication stage, and 1-n , the subject's weight m, age b, current medication dosage E 1-n data, the mean dosage e calculated for the current dosage of each stage, the number of stages n' falling within the evaluation time range, the modified efficacy coefficient i and the subject's efficacy level, as well as instructions for adjusting the dosage of the drug when the subject is in a non-effective level, and instructions for stopping the drug when the subject is in a non-effective level for three consecutive stages;

[0152] The present invention can enable the subjects to know their current efficacy status in a timely and clear manner, which is conducive to the subjects knowing their personal status in a transparent, quantitative and intuitive manner during the clinical research process, and is conducive to improving the subjects' confidence and subsequent compliance;

[0153] The present invention can timely and intelligently adjust the subject's medication dosage for the next stage according to the subject's efficacy level. At the same time, when the subject is at an ineffective level for three consecutive stages, the subject can be guided to stop the medication in a timely manner to avoid further deterioration of the subject's condition or general effect affecting the subject's treatment effect.

[0154] The above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit the same. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that the technical solutions described in the aforementioned embodiments may still be modified, or some of the technical features may be replaced by equivalents. Such modifications or replacements will not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of the present invention.

Claims

1. A clinical research intelligent quality control system, characterized in that: include: The subject data collection unit collects the biochemical test parameter values ​​M of the subjects at each medication stage. 1-n , the subject's weight m, age b, current medication dosage E 1-n and transmit the data to the statistical unit; The statistical unit calculates the mean drug dosage e based on the current drug dosage in each stage: e=(E1+E2……+E n ) / n Among them, E1 represents the dosage in the initial stage, E2 represents the dosage in the second stage, and E n Indicates the dosage of the current final stage, and n represents the number of stages that have been completed; And the mean value of drug dosage e, biochemical test parameter value M 1-n , the subject's weight m, age b, current medication dosage E 1-n The data is bound and stored with the corresponding subject information; Based on the drug evaluation model of efficacy level, the drug use analysis of the subjects is carried out to calculate the biochemical test parameter value M within the set time range. 1-n The efficacy coefficient a and the dosage K per unit body weight of the subject are used to calculate the modified efficacy coefficient i; according to the age-based efficacy level setting conditions, the efficacy level of the subject is judged and a drug effect evaluation report is generated; Evaluation report output unit, generating drug effect evaluation report; The drug adjustment module adjusts the drug dosage of the subject in the next stage according to the efficacy level of the subject. n+1 , and when the subject is in the ineffective level for three consecutive stages, adjust the subject's medication dose for the next stage E n+1 =0, stop the medication.

2. The clinical research intelligent quality control system according to claim 1, characterized in that: The drug evaluation model based on efficacy level includes: The stage setting module sets the value of the number of stages n' that fall within the evaluation time range, 1<n'≤n, when n'=n, it means that all the currently completed stages fall within the evaluation time range, when n'<n, the nth stage and the remaining n-1 stages except the initial stage are randomly selected to fall within the evaluation time range; The subject medication analysis module calculates the biochemical test parameter value M within the set time range 1-n’ The efficacy coefficient a is: (1) When n’ = n, a = (M2 / M1 + M3 / M2 +......M n / M n-1 ) / (n - 1); (2) When n’ < n, a = (M 2’ / M 1’ +M 3’ / M 2’ +......M n’ / M n’-1 ) / (n’ - 1); Among them, M2' represents the biochemical test parameter value corresponding to the first stage of random selection, M 1’ represents the biochemical test parameter value corresponding to the previous stage of the first randomly selected stage; M n’ represents the biochemical test parameter value corresponding to the randomly selected n'th stage, M n’-1 represents the biochemical test parameter value corresponding to the previous stage of the randomly selected n'th stage; Calculate the drug dosage K per unit body weight of the subject: K=e / m Among them, e represents the mean dosage, and m represents the weight of the subject; Calculate the modified efficacy coefficient i: i=K*a*10 5 The subject efficacy level judgment module inputs the efficacy coefficient i and sets conditions based on the age-based efficacy level to judge the subject's efficacy level.

3. The clinical research intelligent quality control system according to claim 2, characterized in that: The age-based efficacy ratings were set as follows: The drug is ineffective for the subject: i<2.06eb / 300; The drug has a general effect on the subjects: 2.06eb / 300≤i<2.14eb / 300; The drug is effective for the subject: i≥2.14eb / 300.

4. The clinical research intelligent quality control system according to claim 3, characterized in that: The drug adjustment module includes: The dosage adjustment unit adjusts the dosage of the subject in the next stage according to the efficacy level of the subject. n+1 ; Invalid: E n+1 =1.3~1.5E n ; General: E n+1 =1.1~1.3E n ; Valid: E n+1 =E n ; The efficacy statistics unit is used to record the class value of the efficacy level of the subjects. The class value of valid records is set to 0, and the class value of invalid and general records is set to 1. The sum p of the efficacy levels of the current completed stage and the previous two stages is calculated.

5. The clinical research intelligent quality control system according to claim 4, characterized in that: The drug adjustment module also includes a risk judgment unit, which judges whether p is less than 3; if so, the drug dosage of the subject in the next stage is E n+1 , the clinical study continues; if not, output E n+1 =0, the clinical study of the subject is completed and the drug discontinuation treatment is carried out; and the drug dosage adjustment result and the drug discontinuation treatment information are sent to the evaluation report output unit.

6. The clinical research intelligent quality control system according to claim 5, characterized in that: The drug effect evaluation report shall at least include the subject's personal information, the biochemical test parameter values ​​of the subject at each medication stage, and 1-n , the subject's weight m, age b, current medication dosage E 1-n data, the mean dosage e calculated for the current stage dosage, the number of stages n' falling within the evaluation time range, the modified efficacy coefficient i and the subject efficacy level, as well as instructions for adjusting the drug dosage when the subject is in a non-effective level, and instructions for stopping the drug when the subject is in a non-effective level for three consecutive stages.

7. A control method of the clinical research intelligent quality control system according to claim 6, characterized in that: The following steps are involved:

1. Collect the biochemical test parameter values ​​M of the subjects at each medication stage 1-n , the subject's weight m, age b, current medication dosage E 1-n data; 2. Calculate the mean dosage e based on the current dosage in each stage: e=(E1+E2……+E n ) / n Among them, E1 represents the dosage in the initial stage, E2 represents the dosage in the second stage, and E n Indicates the dosage of the current final stage, and n represents the number of stages that have been completed; And the mean value of drug dosage e, biochemical test parameter value M 1-n , the subject's weight m, age b, current medication dosage E 1-n The data is bound and stored with the corresponding subject information; 3. Conduct drug analysis on subjects and calculate the biochemical test parameter value M within the set time range 1-n The efficacy coefficient a and the dosage K per unit body weight of the subject are used to calculate the modified efficacy coefficient i; according to the age-based efficacy level setting conditions, the efficacy level of the subject is judged and a drug effect evaluation report is generated; 4. According to the subject's efficacy level, adjust the subject's next stage of medication dosage E n+1 , and when the subject is in the ineffective level for three consecutive stages, adjust the subject's medication dose for the next stage E n+1 =0, stop the drug; 5. Generate a drug effect evaluation report; the drug effect evaluation report shall at least include the subject's personal information, the biochemical test parameter values ​​of the subject at each medication stage, and 1-n , the subject's weight m, age b, current medication dosage E 1-n data, the mean dosage e calculated for the current stage dosage, the number of stages n' falling within the evaluation time range, the modified efficacy coefficient i and the subject efficacy level, as well as instructions for adjusting the drug dosage when the subject is in a non-effective level, and instructions for stopping the drug when the subject is in a non-effective level for three consecutive stages.

8. The control method according to claim 7, characterized in that: Step three includes: 3.1 Set the value of the number of stages n' that fall within the evaluation time range, 1<n'≤n, when n'=n, it means that all the currently completed stages fall within the evaluation time range, when n'<n, select the nth stage and randomly select the remaining n-1 stages except the initial stage to fall within the evaluation time range; 3.2 Calculate the biochemical test parameter value M within the set time range 1-n’ The efficacy coefficient a is: (1) When n’ = n, a = (M2 / M1 + M3 / M2 +......M n / M n-1 ) / (n - 1); (2) When n’ < n, a = (M 2’ / M 1’ +M 3’ / M 2’ +......M n’ / M n’-1 ) / (n’ - 1); Among them, M2' represents the biochemical test parameter value corresponding to the first stage of random selection, M 1’ represents the biochemical test parameter value corresponding to the previous stage of the first randomly selected stage; M n’ represents the biochemical test parameter value corresponding to the randomly selected n'th stage, M n’-1 represents the biochemical test parameter value corresponding to the previous stage of the randomly selected n'th stage; 3.3 Calculate the dosage K per unit body weight of the subject: K=e / m Among them, e represents the mean dosage, and m represents the weight of the subject; 3.4 Calculate the modified efficacy coefficient i: i=K*a*10 5 3.5 Input the efficacy coefficient i and set the conditions based on the efficacy level of the age to determine the efficacy level of the subject.

9. The control method according to claim 8, characterized in that: The age-based efficacy ratings were set as follows: The drug is ineffective for the subject: i<2.06eb / 300; The drug has a general effect on the subjects: 2.06eb / 300≤i<2.14eb / 300; The drug is effective for the subject: i≥2.14eb / 300.

10. The control method according to claim 9, characterized in that: Step 4 include: 4.1 According to the subject's efficacy level, adjust the subject's medication dosage for the next stage E n+1 ; Invalid: E n+1 =1.3~1.5E n ; General: E n+1 =1.1~1.3E n; Valid: E n+1 =E n ; 4.2 Record the class value of the efficacy level of the subject, set the class value of the effective record to 0, and the class value of the invalid and general record to 1, and calculate the sum of the efficacy levels of the current completed stage and the previous two stages, p; 4.3 Determine whether p is less than 3; if so, the dose of the subject in the next stage is E n+1 , the clinical study continues; if not, output E n+1 =0, the clinical study of the subject is completed and the drug discontinuation treatment is carried out; and the drug dosage adjustment result and the drug discontinuation treatment information are sent to the evaluation report output unit.

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