Clinical research risk management system and method thereof

Abstract

The invention discloses a clinical research risk management system and method, and belongs to the technical field of clinical research risk management, and the method comprises the steps: generating a medication planning list corresponding to each type of patient; the patients which do not conform to subject standards, are low in expected lifetime and are low in patient and family member willingness are excluded in advance; calculating an appropriate degree comprehensive value P, and sorting; notifying the patient to sign the related file to become a subject; and reminding the subject to take medicine on time, issuing quantitative medicine to the subject on time, monitoring the medicine taking process of the subject on the premise of ensuring that the subject is prepared with water, and calculating the medication compatibility H. Through the mode, the risks of patient detachment, poor compliance and the like in the clinical research process can be reduced; meanwhile, the medicine taking process is supervised, the medicine taking compatibility H is obtained through calculation, subjects with the low medicine taking compatibility are removed, and the risk of clinical research is further reduced; meanwhile, the composition can be supplemented to the subject in time.

Description

Technical Field

[0001] The present invention relates to the technical field of clinical research risk management, and in particular to a clinical research risk management system and method thereof. 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] The risks in the process of conducting clinical trials can be explained from the following aspects: First, the risks related to the subjects, which are mainly reflected in the dropout of the subjects, poor compliance, etc. At the same time, some subjects also have other diseases, and patients with too many types of diseases will also pose risks to the research results; second, the risks related to drugs, which are mainly reflected in improper storage of drugs, taking too many or missing doses, the effects of combined medications, and taking time that does not meet the requirements. The third is other risks that are difficult to avoid.

[0004] At present, subject-related risks and drug-related risks mainly rely on the subjectivity and consciousness of the subjects. It is difficult to ensure that the screened subjects have high compliance. At the same time, after the patients drop out, it is difficult to replenish subjects with high compliance in time. Drug-related risks are even more difficult to regulate. Therefore, the risk of clinical research is at a high level.

[0005] Based on this, the present invention designs a clinical research risk management system and method thereof to solve the above problems. Summary of the invention

[0006] In view of the above-mentioned shortcomings of the prior art, the present invention provides a clinical research risk management system and method thereof.

[0007] To achieve the above objectives, the present invention is implemented through the following technical solutions:

[0008] A clinical research risk management method, comprising:

[0009] S1. Classify patients according to the disease information entered by the patients, and generate a medication plan list corresponding to each type of patients based on animal experiments;

[0010] S2. Pre-exclude patients who meet at least one of the following conditions:

[0011] a. Not meeting the subject criteria;

[0012] b. The expected survival period is less than 6 months;

[0013] c. The patient's personal willingness is less than 70%;

[0014] d. The willingness of the patient's family members is less than 60%;

[0015] Then, the comprehensive suitability value P of the remaining patients is calculated according to their condition, personal wishes of the patients and the wishes of their families, and the patients are ranked from large to small according to the P value; then the patients are notified to go to the hospital to sign the relevant documents in person to officially become the subjects;

[0016] S3, remind the subject to take medicine on time, distribute a certain amount of medicine to the subject on time, and monitor the subject's medication process under the premise that the subject has prepared water, obtain the subject's medication duration, medication quantity, current medication standard number of times, current total number of medications to be taken, and use the current medication standard number of times and current total number of medications to be taken to calculate the medication compliance H, requiring H ≥ 85%;

[0017] S4. Enter the biochemical index information of the subjects. Researchers adjust the medication, eliminate or provide assistance to the subjects based on the biochemical index evaluation results.

[0018] Furthermore, the step S1 includes:

[0019] S11. Enter the patient's name, age, course of the disease to which the drug belongs, and the type and course of other diseases;

[0020] S12. Patients are classified according to the type and number of diseases they have; patients with the same disease are classified as patients of the same type;

[0021] S13. Generate a medication plan list corresponding to each type of patient based on animal experiments; the medication plan list at least includes the medication plan, expected effects and possible adverse reaction symptoms; the medication plan at least includes the dosage, number of doses, medication time, and examination arrangements.

[0022] Furthermore, the step S2 comprises:

[0023] S21. Compare the biochemical index parameters of the patient with the biochemical index parameter standards of the subjects to determine whether the patient meets the subject standards, and exclude the patient if not; and exclude patients whose expected survival period is less than 6 months based on the biochemical index parameters of the patient;

[0024] S22. Conduct a questionnaire survey on individual patients to obtain their personal willingness scores, using a percentage system; exclude patients whose personal willingness is less than 70%;

[0025] S23. Conduct a questionnaire survey on the patients' families to obtain their willingness scores, using a percentage system; exclude patients whose family willingness is less than 60%;

[0026] S24. The patient and his / her family members simulate participating in the virtual medication experiment for 2 to 3 days, and sign in for online virtual medication regularly according to the medication plan list output by the program planning module; patients who fail to sign in within the specified time are excluded;

[0027] S25, calculating the comprehensive value P of suitability;

[0028] P=A*50%+B*30%+C*20%

[0029] Among them, A represents the patient's condition, B represents the patient's personal willingness score, and C represents the patient's family's willingness score;

[0030] Wherein, A=100-(10*m), m represents the number of types of diseases of the patient; A≥80, B≥70%; C≥60%;

[0031] S26. Sort the remaining patients according to their P values ​​from large to small;

[0032] S27. Set and store the number of subjects n1 determined by the researcher, set and store the number of patients n2 to whom subject selection information needs to be sent; select n2 patients with the highest P value ranking; send the subject selection information to the n2 patients with the highest P value ranking, and prompt the patients to go to the hospital to sign the relevant documents in person. The first n patients who sign officially become subjects.

[0033] Furthermore, n2=1.2~1.5n1.

[0034] Furthermore, the step S3 includes:

[0035] S31. Set the storage temperature of the drug according to the drug storage requirements and store the drug at an appropriate temperature;

[0036] S32. According to the medication plan list output by the program planning module, 5 to 10 minutes before the set time and at the set time, the subject is reminded to prepare water in advance for medication; after each reminder at the set time, the current total number of medications to be taken is increased by 1, and the current total number of medications to be taken is updated;

[0037] S33, the subject places the water cup on the sensing unit, and the drug dispensing module starts dispensing the drug when the set time is reached, dispensing a fixed amount of the drug to the subject; if the water cup is not placed on the sensing unit, the drug dispensing module does not start when the set time is reached;

[0038] The monitoring module starts to collect videos and film the process of the subject taking the medicine; if the drug dispensing module does not dispense the medicine, the monitoring module will not start;

[0039] S34, performing image processing on the subject's medication process to capture the time point Tn of the subject's last medication taking action under a single medication reminder and the number of medications K1, K2...K2 taken at each medication taking action;

[0040] Calculate the duration of medication T = Tn-T1;

[0041] Among them, T1 represents the time point when the drug dispensing module is started, and Tn represents the time point when the last medication action occurs;

[0042] Calculate the sum of the number of medications taken Ksum = K1+K2…+Kn, and identify it as the number of medications taken;

[0043] If the monitoring module is not started, K and = 0, T = 0;

[0044] Determine whether the duration and quantity of medication are within the preset range. If so, add 1 to the current standard number of medications, update the current standard number of medications and send it to the medication compliance calculation unit; if not, the current standard number of medications remains unchanged;

[0045] S35. Calculate the medication coordination degree H:

[0046] H=Q / T*100%

[0047] Among them, Q represents the current number of standard medication times, and T represents the total number of medication times that should be taken;

[0048] S36. For subjects with H < 85%, the reasons are sent and the subject status is released, and the number of subjects whose status is released d1 is recorded; at the same time, the processor communicates with the subject screening module to add additional subjects.

[0049] Furthermore, in step S36, 1.2 to 1.5d1 patients with the highest P value ranking among the unselected patients are selected according to d1, and the subject selection information is sent to the patients, prompting them to go to the hospital to sign the relevant documents in person. The first d1 patients who sign officially become the supplementary subjects.

[0050] Furthermore, the step S4 comprises:

[0051] S41. Conduct regular inspections on subjects according to the inspection schedule of the medication plan list and input the biochemical indicators of the subjects;

[0052] S42. The researchers assess the patients’ status based on biochemical indicators, including whether they are in the phases of improvement, ineffectiveness, mild deterioration, or severe deterioration. The researchers adjust the medication plan for subjects in the phases of ineffectiveness and mild deterioration, and update the medication plan list for the subjects.

[0053] S43. Subjects who are in the severe deterioration stage or who are in the mild deterioration stage for three consecutive times, as well as subjects whose subject status is released at the request of the patient, explain the reasons and release the subject status and record the number of subjects whose status is released d2; at the same time, the subject elimination module communicates with the data processing unit of the subject screening module to add subjects;

[0054] S44. The hospital receives information about subjects who are in the severe deterioration stage and those who are in the mild deterioration stage for three consecutive times, so as to facilitate rescue of the subjects.

[0055] Furthermore, in step S43, 1.2 to 1.5d2 patients with the highest P value ranking among the unselected patients are selected according to d2, and the subject selection information is sent to the patients through the communication unit A, prompting the patients to go to the hospital to sign the relevant documents in person, and the first d2 patients who sign officially become the supplementary subjects.

[0056] Furthermore, mild deterioration means that the difference between the biochemical index test value and the biochemical index standard value is no more than 20%, and severe deterioration stage means that the difference between the biochemical index test value and the biochemical index standard value is more than 20%.

[0057] A clinical research risk management system, the system comprising:

[0058] 1. The program planning module classifies patients according to the disease information entered by the patients, and generates a medication planning list corresponding to each type of patient based on animal experiments;

[0059] 2. Subject screening module, including:

[0060] The condition assessment unit determines whether the patient meets the subject criteria and excludes the patient if not; and excludes patients whose expected survival time is less than 6 months based on the patient's biochemical index parameters;

[0061] The patient's personal willingness assessment unit conducts a questionnaire survey on individual patients to obtain the patient's personal willingness score, which is based on a percentage system; patients whose personal willingness is less than 70% are excluded;

[0062] The patient family willingness assessment unit conducts a questionnaire survey on the patient family and obtains the patient family willingness score, which is based on a percentage system; patients whose family willingness is less than 60% are excluded;

[0063] In the simulation experiment unit, the patient and his / her family members simulate participating in the virtual medication experiment for 2 to 3 days, and sign in for online virtual medication regularly according to the medication plan list output by the program planning module; patients who fail to sign in within the specified time are excluded;

[0064] A fitness comprehensive value P calculation unit, which calculates the fitness comprehensive value P;

[0065] P=A*50%+B*30%+C*20%

[0066] Among them, A represents the patient's condition, B represents the patient's personal willingness score, and C represents the patient's family's willingness score; the P value reflects the suitability of the patient as a subject;

[0067] Among them, A = 100-(10*m), A ≥ 80, excluding patients with more than 3 types of diseases; B ≥ 70%; C ≥ 60%;

[0068] The P value sorting unit sorts the remaining patients according to the P value from large to small;

[0069] The information processing unit, based on the number of subjects n1 determined by the researcher, notifies n2 patients to go to the hospital to sign relevant documents in person. The first n1 patients who sign officially become subjects; patients who do not meet the requirements are excluded;

[0070] 3. Medication management module, including:

[0071] The medication reminder unit, based on the medication plan list output by the program planning module, reminds the subject to prepare water in advance for medication 5 to 10 minutes before the set time and at the set time; each time the reminder reaches the set time, the total number of medications that should be taken is increased by 1, and the total number of medications that should be taken is updated;

[0072] The drug storage module sets the storage temperature of the drug according to the drug storage requirements and stores the drug at an appropriate temperature;

[0073] The sensing unit senses the weight of the water cup and transmits the information to the processor, which sends a start signal to the drug dispensing module when the set time is reached;

[0074] The drug dispensing module starts dispensing the drug after receiving the start signal from the processor, and dispenses a fixed amount of the drug to the subject;

[0075] Monitoring module: after the drug dispensing module finishes dispensing the drug, the processor sends a start signal to the monitoring module, and the monitoring module starts to collect video, shoots the process of the subject taking the drug, and transmits it to the processor;

[0076] The processor performs image processing on the subject's medication process to capture the time point Tn of the last medication taking action under the subject's single medication reminder and the number of medications K1, K2...K2 taken when each medication taking action occurs;

[0077] Calculate the duration of medication T = Tn-T1;

[0078] Calculate the sum of the number of medications taken Ksum = K1+K2…+Kn, and identify it as the number of medications taken;

[0079] Determine whether the duration and quantity of medication are within the preset range. If so, add 1 to the current standard number of medications, update the current standard number of medications and send it to the medication compliance calculation unit; if not, the current standard number of medications remains unchanged;

[0080] Medication coordination calculation unit, calculates medication coordination H:

[0081] H=Q / T*100%

[0082] Among them, Q represents the current number of standard medication times, and T represents the total number of medication times that should be taken;

[0083] Control H ≥ 85%, and exclude subjects with H < 85%;

[0084] For subjects with H < 85% in communication unit B, the processor sends the reason through communication unit B and releases the subject identity, and records the number of subjects released d1; at the same time, the processor communicates with the data processing unit of the subject screening module, selects 1.2 to 1.5d1 patients with the highest P value among the unselected patients according to d1, and sends the subject selection information to the patient through communication unit A, prompting the patient to go to the hospital to sign the relevant documents in person, and the first d1 patients who sign officially become the supplementary subjects;

[0085] 4. Biochemical index entry and supervision module, which enters the biochemical index information of the subjects. Researchers adjust the medication, eliminate or provide assistance to the subjects based on the biochemical index evaluation results.

[0086] Beneficial Effects

[0087] The patients of the present invention can understand the planning, expected effects and possible adverse reaction symptoms of the clinical research experiment before becoming the subjects, which is helpful to exclude patients who are not satisfied with the medication planning list from becoming the subjects to a certain extent in advance;

[0088] The present invention can pre-exclude patients who do not meet the subject criteria, have a short expected survival period, have low personal willingness, or have low family willingness. At the same time, by calculating the comprehensive value of suitability P, the standard that can represent the overall suitability of the patients is obtained and ranked, and better and more actively participating patients are selected, which is conducive to reducing the risk of patient withdrawal and poor compliance during clinical research.

[0089] The present invention can remind the subjects to take medicine and prepare water in advance and on time, and dispense medicine on the premise of putting the water cup in place first, so as to avoid the subjects looking for water after dispensing the medicine, delaying the medication time or forgetting to take medicine. At the same time, the medication process is supervised, the medication duration and the number of medicines taken at each medication action are output, the current medication standard number of times is obtained, and the medication compliance H is calculated, and the subjects with low medication compliance are eliminated, so as to further reduce the risk of clinical research; at the same time, the subjects can be supplemented in time;

[0090] The present invention can enable researchers to timely adjust the medication plan of subjects in the ineffective and mildly deteriorated stages, eliminate and promptly rescue subjects in the severe deterioration stage and those who have been in the mildly deteriorated stage for three consecutive times, and withdraw subjects at their own will. BRIEF DESCRIPTION OF THE DRAWINGS

[0091] 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.

[0092] Figure 1 The present invention is a flow chart of a clinical research risk management method.

[0093] Figure 2 The present invention is a flowchart of the subject screening method.

[0094] Figure 3 Flow chart of the medication management method of the present invention.

[0095] Figure 4 This is a structural diagram of a clinical research risk management system of the present invention.

[0096] Figure 5 It is a structural diagram of the solution planning module in the present invention.

[0097] Figure 6 This is a structural diagram of the subject screening module in the present invention.

[0098] Figure 7 It is a structural diagram of the information processing unit in the present invention.

[0099] Figure 8 This is a structural diagram of the medication management module in the present invention.

[0100] Fig. 9 It is a structural diagram of the biochemical index input and supervision module in the present invention. DETAILED DESCRIPTION

[0101] 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.

[0102] The present invention will be further described below in conjunction with the embodiments.

[0103] Example 1

[0104] Please refer to the instruction manual Figure 1 , a clinical research risk management method, comprising the following steps:

[0105] S1. Patients are classified according to the disease information entered by the patients, and a medication plan list corresponding to each type of patient is generated based on animal experiments; patients can understand the medication plan of clinical research experiments before becoming subjects, which is conducive to excluding patients who are not satisfied with the medication plan list from becoming subjects to a certain extent in advance;

[0106] Specifically, the step S1 includes:

[0107] S11. Enter the patient's name, age, course of the disease to which the drug belongs, and the type and course of other diseases;

[0108] S12. Patients are classified according to the type and number of diseases they have; patients with the same disease are classified as patients of the same type;

[0109] S13. Generate a medication plan list corresponding to each type of patient based on animal experiments; the medication plan list at least includes medication regimen, expected effects and possible adverse reaction symptoms; the medication regimen at least includes dosage, number of medications, medication time, and examination arrangements; patients can understand the planning, expected effects and possible adverse reaction symptoms of clinical research experiments before becoming subjects, which is conducive to excluding patients who are not satisfied with the medication plan list from becoming subjects to a certain extent in advance;

[0110] S2. Pre-exclude patients who meet at least one of the following conditions:

[0111] a. Not meeting the subject criteria;

[0112] b. The expected survival period is less than 6 months;

[0113] c. The patient's personal willingness is less than 70%;

[0114] d. The willingness of the patient's family members is less than 60%;

[0115] Then, the comprehensive suitability value P of the remaining patients is calculated according to their condition, personal wishes of the patients and the wishes of their families, and the patients are ranked from large to small according to the P value; then the patients are notified to go to the hospital to sign the relevant documents in person to officially become the subjects;

[0116] like Figure 2 As shown, specifically, step S2 includes:

[0117] S21. Compare the biochemical index parameters of the patient with the biochemical index parameter standards of the subjects to determine whether the patient meets the subject standards, and exclude the patient if not; and exclude patients whose expected survival period is less than 6 months based on the biochemical index parameters of the patient;

[0118] S22. Conduct a questionnaire survey on individual patients to obtain the patient's personal willingness score, using a percentage system; exclude patients whose personal willingness is less than 70%; this can ensure that the patient's personal willingness is relatively strong and reduce the probability of poor compliance;

[0119] S23. Conduct a questionnaire survey on the patients' family members to obtain their willingness scores, using a percentage system; exclude patients whose family members' willingness is less than 60%; this can ensure that the patients' family members have a high degree of support and avoid the situation where the patients' family members obstruct the patients from taking the medicine;

[0120] S24, the patient and his / her family members simulate participating in the virtual medication experiment for 2 to 3 days, and sign in for online virtual medication regularly according to the medication planning list output by the program planning module 100; patients who fail to sign in within the prescribed time are excluded;

[0121] S25, calculating the comprehensive value P of suitability;

[0122] P=A*50%+B*30%+C*20%

[0123] Among them, A represents the patient's condition, B represents the patient's personal willingness score, and C represents the patient's family's willingness score; the P value reflects the suitability of the patient as a subject;

[0124] Among them, A=100-(10*m). In order to avoid some patients having a large number of diseases, which may affect the health of patients in clinical research, it is stipulated that A≥80, excluding patients with more than 3 types of diseases; B≥70%; C≥60%.

[0125] S26. Sort the remaining patients according to their P values ​​from large to small;

[0126] S27, setting and storing the number of subjects n1 determined by the researcher, setting and storing the number of patients n2 to whom subject selection information needs to be sent; selecting n2 patients with the highest P value ranking; sending subject selection information to the n2 patients with the highest P value ranking, n2 = 1.2 to 1.5n1, prompting the patients to go to the hospital to sign the relevant documents in person, and the first n patients who sign officially become subjects;

[0127] S3, remind the subject to take medicine on time, distribute a certain amount of medicine to the subject on time, and monitor the subject's medication process under the premise that the subject has prepared water, obtain the subject's medication duration, medication quantity, current medication standard number of times, current total number of medications to be taken, and use the current medication standard number of times and current total number of medications to be taken to calculate the medication compliance H, requiring H ≥ 85%;

[0128] The present invention can pre-exclude patients who do not meet the subject criteria, have a short expected survival period, have low personal willingness, or have low family willingness. At the same time, by calculating the comprehensive value of suitability P, the standard that can represent the overall suitability of the patients is obtained and ranked, and better and more actively participating patients are selected, which is conducive to reducing the risk of patient withdrawal and poor compliance during clinical research.

[0129] like Figure 3 As shown, specifically, step S3 includes:

[0130] S31. Set the storage temperature of the drug according to the drug storage requirements to store the drug at an appropriate temperature to avoid the drug becoming ineffective or having its effect reduced due to improper storage;

[0131] S32, according to the medication planning list output by the program planning module 100, 5 to 10 minutes before the set time and at the set time, remind the subject to prepare water in advance for medication; after each reminder at the set time, the current total number of medications to be taken is increased by 1, and the current total number of medications to be taken is updated;

[0132] S33, the subject places the water cup on the sensing unit 305, and the drug dispensing module 303 starts dispensing the drug when the set time is reached, dispensing a fixed amount of the drug to the subject; if the water cup is not placed on the sensing unit 305, the drug dispensing module 303 does not start when the set time is reached;

[0133] S33, the monitoring module 304 starts to collect video and shoot the process of the subject taking medicine; if the medicine dispensing module 303 does not dispense medicine, the monitoring module 304 does not start;

[0134] S34, image processing is performed on the subject's medication process. Since the subject may not be able to take all the medication in one gulp after a single reminder, and may need to drink water several times to take the medication, it is necessary to capture the time point Tn of the subject's last medication action (drinking water with head tilted back) under a single medication reminder and the number of medications K1, K2...K2 taken at each medication action;

[0135] Calculate the medication duration T = Tn-T1; subtract the time point when the medication dispensing module is started from the time point when the last medication action occurred, and the medication duration T can be roughly obtained;

[0136] Among them, T1 represents the time point when the drug dispensing module is started, and Tn represents the time point when the last medication action occurs;

[0137] Calculate the sum of the number of medications taken Ksum = K1+K2…+Kn, and identify it as the number of medications taken;

[0138] If the monitoring module 304 is not started, K and = 0, T = 0;

[0139] Determine whether the duration of medication and the number of medications are within the preset range, and set T < 5min, K and = K (e.g., 5 tablets). If so, the current medication standard number of times is increased by 1, and the current medication standard number of times is updated and sent to the medication compliance calculation unit 306; if not, the current medication standard number of times remains unchanged;

[0140] S35. Calculate the medication coordination degree H:

[0141] H=Q / T*100%

[0142] Among them, Q represents the current number of standard medication times, and T represents the total number of medication times that should be taken;

[0143] S36, for subjects with H < 85%, send the reason and release the subject identity, and record the number d1 of the subjects released; at the same time, the processor communicates with the subject screening module 200, selects 1.2 to 1.5d1 patients with the top P value ranking among the unselected patients according to d1, and sends the subject selection information to the patients, prompting them to go to the hospital to sign the relevant documents in person, and the first d1 patients who sign officially become the supplementary subjects;

[0144] The present invention can remind the subjects to take medicine and prepare water in advance, and dispense medicine on the premise that the water cup is placed first, so as to avoid the subjects looking for water after dispensing the medicine, delaying the medication time or forgetting to take the medicine. At the same time, the medication process is supervised, and the current standard number of medication is obtained, and the medication compliance H is calculated. Subjects with low medication compliance are eliminated, so as to further reduce the risk of clinical research; at the same time, subjects can be added in time;

[0145] S4. Enter the biochemical index information of the subjects. The researchers will adjust the medication, eliminate or rescue the subjects according to the biochemical index evaluation results;

[0146] Specifically, step S4 includes:

[0147] S41. Conduct regular inspections on subjects according to the inspection schedule of the medication plan list and input the biochemical indicators of the subjects;

[0148] S42. The researchers evaluate the patients’ stage of improvement, ineffectiveness, mild deterioration, and severe deterioration based on biochemical indicators; mild deterioration means that the difference between the biochemical indicator test value and the biochemical indicator standard value is no more than 20%, and severe deterioration means that the difference between the biochemical indicator test value and the biochemical indicator standard value is more than 20%; the researchers adjust the medication plan of the subjects in the ineffective and mild deterioration stages, and update the medication plan list of the subjects;

[0149] S43, subjects who are in the severe deterioration stage and have been in the mild deterioration stage for three consecutive times, as well as subjects whose subject status is released at the request of the patients, explain the reasons and release the subject status and record the number d2 of subjects whose status is released; at the same time, the subject elimination module 403 communicates with the data processing unit 2071 of the subject screening module 200, selects 1.2 to 1.5d2 patients with the top P value ranking among the unselected patients according to d2, and sends the subject selection information to the patient through the communication unit A2072, prompting the patient to go to the hospital to sign the relevant documents in person, and the first d2 patients who sign officially become the supplementary subjects;

[0150] S44. The hospital receives information about subjects who are in the severe deterioration stage and those who are in the mild deterioration stage for three consecutive times, so as to facilitate rescue of the subjects.

[0151] The present invention can enable researchers to timely adjust the medication plan of subjects in the ineffective and mildly deteriorated stages, and to eliminate and promptly rescue subjects who are in the severe deterioration stage or have been in the mildly deteriorated stage for three consecutive times.

[0152] Example 2

[0153] Please refer to the instruction manual Figure 5 , a clinical research risk management system, the system comprising:

[0154] 1. The program planning module 100 classifies patients according to the disease information entered by the patients, and generates a medication planning list corresponding to each type of patients according to the animal experiment; the patients can understand the medication planning of the clinical research experiment before becoming the subjects, which is conducive to excluding patients who are not satisfied with the medication planning list from becoming the subjects in advance to a certain extent;

[0155] like Figure 5As shown, the program planning module 100 includes:

[0156] The patient information input unit 101 inputs the patient's name, age, course of the disease to which the drug belongs, and the type and course of other diseases;

[0157] The disease classification unit 102 classifies patients according to the type and number of diseases they have; patients with the same disease are classified as patients of the same type;

[0158] The medication planning unit 103 generates a medication planning list corresponding to each type of patient based on the animal experiment; the medication planning list at least includes medication regimen, expected effects and possible adverse reaction symptoms; the medication regimen at least includes medication dosage, medication frequency, medication time and examination arrangement; patients can understand the planning, expected effects and possible adverse reaction symptoms of clinical research experiments before becoming subjects, which is conducive to excluding patients who are not satisfied with the medication planning list from becoming subjects to a certain extent in advance;

[0159] 2. Subject screening module 200 pre-excludes patients who meet at least one of the following conditions:

[0160] a. Not meeting the subject criteria;

[0161] b. The expected survival period is less than 6 months;

[0162] c. The patient's personal willingness is less than 70%;

[0163] d. The willingness of the patient's family members is less than 60%;

[0164] Then, the comprehensive suitability value P of the remaining patients is calculated according to their condition, personal wishes of the patients and the wishes of their families, and the patients are ranked from large to small according to the P value; then the patients are notified to go to the hospital to sign the relevant documents in person to officially become the subjects;

[0165] like Figure 6 As shown, the subject screening module 200 includes:

[0166] The condition assessment unit 201 compares the biochemical index parameters of the patient with the subject biochemical index parameter standards to determine whether the patient meets the subject standards, and excludes the patient if not; and finds a patient whose expected survival period is less than 6 months based on the patient's biochemical index parameters and excludes the patient;

[0167] The patient personal willingness evaluation unit 202 conducts a questionnaire survey on the individual patients to obtain the patient personal willingness score, using a percentage system; patients whose personal willingness is less than 70% are excluded; this ensures that the patient's personal willingness is relatively strong and reduces the probability of poor compliance;

[0168] The patient family willingness evaluation unit 203 conducts a questionnaire survey on the patient family to obtain the patient family willingness score, using a percentage system; excludes patients whose patient family willingness is less than 60%; ensures that the patient family has a high degree of support and avoids the situation where the patient family obstructs the patient from taking the medicine;

[0169] In the simulation experiment unit 204, the patient and his / her family members simulate participating in the virtual medication experiment for 2 to 3 days, and sign in for online virtual medication according to the medication planning list output by the program planning module 100 at regular intervals; patients who fail to sign in within the prescribed time are excluded;

[0170] A suitability comprehensive value P calculation unit 205 calculates the suitability comprehensive value P;

[0171] P=A*50%+B*30%+C*20%

[0172] Among them, A represents the patient's condition, B represents the patient's personal willingness score, and C represents the patient's family's willingness score; the P value reflects the suitability of the patient as a subject;

[0173] Among them, A=100-(10*m). In order to avoid some patients having a large number of diseases, which may affect the health of patients in clinical research, it is stipulated that A≥80, excluding patients with more than 3 types of diseases; B≥70%; C≥60%.

[0174] A P value sorting unit 206 sorts the remaining patients according to the P value from large to small;

[0175] The information processing unit 207 notifies n2 patients to go to the hospital to sign relevant documents in person according to the number of subjects n1 determined by the researcher, and the first n1 patients who sign officially become subjects;

[0176] like Figure 6 As shown, the information processing unit 207 includes:

[0177] The data processing unit 2071 sets and stores the number of subjects n1 determined by the researcher, sets and stores the number of patients n2 for which subject selection information needs to be sent; and selects n2 patients with the highest P value ranking;

[0178] Communication unit A2072 sends the subject selection information to the n2 patients with the highest P value, n2=1.2-1.5n1, and prompts the patients to go to the hospital to sign the relevant documents in person. The first n patients who sign officially become the subjects;

[0179] 3. Medication management module 300, reminding the subject to take medicine on time, dispensing a fixed amount of medicine to the subject on time, and monitoring the subject's medication process on the premise that the subject has prepared water, obtaining the subject's medication duration, medication quantity, current medication standard number of times, and current total number of medications to be taken, and using the current medication standard number of times and the current total number of medications to be taken to calculate the medication compliance H, requiring H ≥ 85%;

[0180] like Figure 6 As shown, the medication management module 300 includes:

[0181] The medication reminder unit 301, based on the medication plan list output by the program planning module 100, reminds the subject to prepare water in advance for medication 5 to 10 minutes before the set time and at the set time; after each reminder at the set time, the current total number of medications to be taken is increased by 1, and the current total number of medications to be taken is updated;

[0182] The drug storage module 302 sets the storage temperature of the drug according to the drug storage requirements, so as to store the drug at a suitable temperature and avoid the drug becoming ineffective or having its effect reduced due to improper storage;

[0183] The sensing unit 305 senses the weight of the water cup and transmits the information to the processor, which sends a start signal to the drug dispensing module 303 when the set time is reached;

[0184] The drug dispensing module 303 starts dispensing the drug after receiving the start signal sent by the processor, and dispenses a fixed amount of the drug to the subject;

[0185] Monitoring module 304: after the drug dispensing module finishes dispensing the drug, the processor sends a start signal to the monitoring module 304, and the monitoring module 304 starts to collect video, shoots the process of the subject taking the drug, and transmits it to the processor;

[0186] Processor 308 performs image processing on the subject's medication process, capturing the time point Tn of the subject's last medication action (tilting his head back to drink water) under a single medication reminder and the number of medications K1, K2, ... K2 taken at each medication action;

[0187] Calculate the duration of medication T = Tn-T1;

[0188] Among them, T1 represents the time point when the drug dispensing module is started, and Tn represents the time point when the last medication action occurs;

[0189] Calculate the sum of the number of medications taken Ksum = K1+K2…+Kn, and identify it as the number of medications taken;

[0190] Determine whether the duration of medication and the amount of medication are both within the preset range. If so, the current medication standard number of times is increased by 1, the current medication standard number of times is updated and sent to the medication compliance calculation unit 306; if not, the current medication standard number of times remains unchanged;

[0191] It should be noted that if the water cup is not placed on the sensing unit 305, the medicine dispensing module 303 will not start when the set time is reached; if the medicine dispensing module 303 does not dispense medicine, the monitoring module 304 will not start; if the monitoring module 304 is not started, K and = 0, T = 0;

[0192] The medication coordination degree calculation unit 306 calculates the medication coordination degree H:

[0193] H=Q / T*100%

[0194] Among them, Q represents the current number of standard medication times, and T represents the total number of medication times that should be taken;

[0195] Control H ≥ 85%, and exclude subjects with H < 85%;

[0196] For subjects with H < 85% in the communication unit B307, the processor sends the reason through the communication unit B307 and releases the subject identity, and records the number d1 of the subjects whose identities have been released; at the same time, the processor communicates with the data processing unit 2071 of the subject screening module 200, selects 1.2 to 1.5d1 patients with the highest P value among the unselected patients according to d1, and sends the subject selection information to the patient through the communication unit A2072, prompting the patient to go to the hospital to sign the relevant documents in person, and the first d1 patients who sign officially become the supplementary subjects;

[0197] 4. Biochemical index input and supervision module 400, inputs the biochemical index information of the subject, and the researcher adjusts the medication, eliminates or rescues the subject according to the biochemical index evaluation results;

[0198] like Figure 6 As shown, the biochemical index input and monitoring module 400 includes:

[0199] The biochemical index input unit 401 performs regular inspections on the subjects according to the inspection schedule of the medication plan list and inputs the biochemical indexes of the subjects;

[0200] Adverse reaction evaluation unit 402, researchers evaluate the patients’ stage of improvement, ineffectiveness, mild deterioration, and severe deterioration based on biochemical indicators; mild deterioration means that the difference between the biochemical indicator test value and the biochemical indicator standard value is no more than 20%, and severe deterioration means that the difference between the biochemical indicator test value and the biochemical indicator standard value is more than 20%;

[0201] The subject elimination module 403 explains the reasons and removes the subject identities of the subjects who are in the severe deterioration stage and the subjects who are in the mild deterioration stage for three consecutive times, as well as the subjects whose subject identities are removed at the request of the patients, and records the number of subjects whose identities are removed, d2; at the same time, the subject elimination module 403 communicates with the data processing unit 2071 of the subject screening module 200, selects 1.2 to 1.5d2 patients with the top P value ranking among the unselected patients according to d2, and sends the subject selection information to the patients through the communication unit A2072, prompting the patients to go to the hospital to sign the relevant documents in person, and the first d2 patients who sign officially become the supplementary subjects;

[0202] In the hospital emergency system 404, researchers adjust the medication plans of subjects who are in the ineffective or mildly deteriorated stage, and update the medication plan list of the subjects; the hospital receives information on subjects who are in the severe deterioration stage and who have been in the mildly deteriorated stage for three consecutive times, so as to facilitate the rescue of the subjects.

[0203] 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 risk management method, It is characterized in that The method comprises: S1. Classify patients according to the disease information entered by the patients, and generate a medication plan list corresponding to each type of patients based on animal experiments; S2. Pre-exclude patients who meet at least one of the following conditions: a. Not meeting the subject criteria; b. The expected survival period is less than 6 months; c. The patient's personal willingness is less than 70%; d. The willingness of the patient's family members is less than 60%; Then, the comprehensive suitability value P of the remaining patients is calculated according to their condition, personal wishes of the patients and the wishes of their families, and the patients are ranked from large to small according to the P value; then the patients are notified to go to the hospital to sign the relevant documents in person to officially become the subjects; S3, remind the subject to take medicine on time, distribute a certain amount of medicine to the subject on time, and monitor the subject's medication process under the premise that the subject has prepared water, obtain the subject's medication duration, medication quantity, current medication standard number of times, current total number of medications to be taken, and use the current medication standard number of times and current total number of medications to be taken to calculate the medication compliance H, requiring H ≥ 85%; S4. Enter the biochemical index information of the subjects. Researchers adjust the medication, eliminate or provide assistance to the subjects based on the biochemical index evaluation results.

2. The clinical research risk management method according to claim 1, It is characterized in that The step S1 comprises: S11. Enter the patient's name, age, course of the disease to which the drug belongs, and the type and course of other diseases; S12. Patients are classified according to the type and number of diseases they have; patients with the same disease are classified as patients of the same type; S13. Generate a medication plan list corresponding to each type of patient based on animal experiments; the medication plan list at least includes the medication plan, expected effects and possible adverse reaction symptoms; the medication plan at least includes the dosage, number of doses, medication time, and examination arrangements.

3. The clinical research risk management method according to claim 2, It is characterized in that The step S2 comprises: S21. Compare the biochemical index parameters of the patient with the biochemical index parameter standards of the subjects to determine whether the patient meets the subject standards, and exclude the patient if not; and exclude patients whose expected survival period is less than 6 months based on the biochemical index parameters of the patient; S22. Conduct a questionnaire survey on individual patients to obtain their personal willingness scores, using a percentage system; exclude patients whose personal willingness is less than 70%; S23. Conduct a questionnaire survey on the patients' families to obtain their willingness scores, using a percentage system; exclude patients whose family willingness is less than 60%; S24. The patient and his / her family members simulate participating in the virtual medication experiment for 2 to 3 days, and sign in for online virtual medication regularly according to the medication plan list output by the program planning module; patients who fail to sign in within the specified time are excluded; S25, calculating the comprehensive value P of suitability; P=A*50%+B*30%+C*20% Among them, A represents the patient's condition, B represents the patient's personal willingness score, and C represents the patient's family's willingness score; Wherein, A=100-(10*m), m represents the number of types of diseases of the patient; A≥80, B≥70%; C≥60%; S26. Sort the remaining patients according to their P values ​​from large to small; S27. Set and store the number of subjects n1 determined by the researcher, set and store the number of patients n2 to whom subject selection information needs to be sent; select n2 patients with the highest P value ranking; send the subject selection information to the n2 patients with the highest P value ranking, and prompt the patients to go to the hospital to sign the relevant documents in person. The first n patients who sign officially become subjects.

4. The clinical research risk management method according to claim 3, It is characterized in that n2=1.2~1.5n1.

5. The clinical research risk management method according to claim 1, It is characterized in that The step S3 comprises: S31. Set the storage temperature of the drug according to the drug storage requirements and store the drug at an appropriate temperature; S32. According to the medication plan list output by the program planning module, 5 to 10 minutes before the set time and at the set time, the subject is reminded to prepare water in advance for medication; after each reminder at the set time, the current total number of medications to be taken is increased by 1, and the current total number of medications to be taken is updated; S33, the subject places the water cup on the sensing unit, and the drug dispensing module starts dispensing the drug when the set time is reached, dispensing a fixed amount of the drug to the subject; if the water cup is not placed on the sensing unit, the drug dispensing module does not start when the set time is reached; The monitoring module starts to collect videos and film the process of the subject taking the medicine; if the drug dispensing module does not dispense the medicine, the monitoring module will not start; S34, performing image processing on the subject's medication process to capture the time point Tn of the subject's last medication taking action under a single medication reminder and the number of medications K1, K2...K2 taken at each medication taking action; Calculate the duration of medication T = Tn-T1; Among them, T1 represents the time point when the drug dispensing module is started, and Tn represents the time point when the last medication action occurs; Calculate the sum of the number of medications taken Ksum = K1+K2…+Kn, and identify it as the number of medications taken; If the monitoring module is not started, K and = 0, T = 0; Determine whether the duration and quantity of medication are within the preset range. If so, add 1 to the current standard number of medications, update the current standard number of medications and send it to the medication compliance calculation unit; if not, the current standard number of medications remains unchanged; S35. Calculate the medication coordination degree H: H=Q / T*100% Among them, Q represents the current number of standard medication times, and T represents the total number of medication times that should be taken; S36. For subjects with H < 85%, the reasons are sent and the subject status is released, and the number of subjects whose status is released d1 is recorded; at the same time, the processor communicates with the subject screening module to add additional subjects.

6. The clinical research risk management method according to claim 5, It is characterized in that In step S36, 1.2 to 1.5d1 patients with the highest P value ranking among the unselected patients are selected according to d1, and the subject selection information is sent to the patients, prompting them to go to the hospital to sign the relevant documents in person. The first d1 patients who sign officially become the supplementary subjects.

7. The clinical research risk management method according to claim 6, It is characterized in that The step S4 comprises: S41. Conduct regular inspections on subjects according to the inspection schedule of the medication plan list and input the biochemical indicators of the subjects; S42. The researchers assess the patients’ status based on biochemical indicators, including whether they are in the phases of improvement, ineffectiveness, mild deterioration, or severe deterioration. The researchers adjust the medication plan for subjects in the phases of ineffectiveness and mild deterioration, and update the medication plan list for the subjects. S43. Subjects who are in the severe deterioration stage or who are in the mild deterioration stage for three consecutive times, as well as subjects whose subject status is released at the request of the patient, explain the reasons and release the subject status and record the number of subjects whose status is released d2; at the same time, the subject elimination module communicates with the data processing unit of the subject screening module to add subjects; S44. The hospital receives information about subjects who are in the severe deterioration stage and those who are in the mild deterioration stage for three consecutive times, so as to facilitate rescue of the subjects.

8. The clinical research risk management method according to claim 7, It is characterized in that In step S43, 1.2 to 1.5d2 patients with the highest P value ranking among the unselected patients are selected according to d2, and the subject selection information is sent to the patients through the communication unit A, prompting the patients to go to the hospital to sign the relevant documents in person. The first d2 patients who sign officially become the supplementary subjects.

9. The clinical research risk management method according to claim 7, It is characterized in that Mild deterioration means that the difference between the biochemical index test value and the biochemical index standard value is no more than 20%, and severe deterioration means that the difference between the biochemical index test value and the biochemical index standard value is more than 20%.

10. A clinical research risk management system, It is characterized in that The system comprises:

1. The program planning module classifies patients according to the disease information entered by the patients, and generates a medication planning list corresponding to each type of patient based on animal experiments; 2. Subject screening module, including: The condition assessment unit determines whether the patient meets the subject criteria and excludes the patient if not; and excludes patients whose expected survival time is less than 6 months based on the patient's biochemical index parameters; The patient's personal willingness assessment unit conducts a questionnaire survey on individual patients to obtain the patient's personal willingness score, which is based on a percentage system; patients whose personal willingness is less than 70% are excluded; The patient family willingness assessment unit conducts a questionnaire survey on the patient family and obtains the patient family willingness score, which is based on a percentage system; patients whose family willingness is less than 60% are excluded; In the simulation experiment unit, the patient and his / her family members simulate participating in the virtual medication experiment for 2 to 3 days, and sign in for online virtual medication regularly according to the medication plan list output by the program planning module; patients who fail to sign in within the specified time are excluded; A fitness comprehensive value P calculation unit, which calculates the fitness comprehensive value P; P=A*50%+B*30%+C*20% Among them, A represents the patient's condition, B represents the patient's personal willingness score, and C represents the patient's family's willingness score; the P value reflects the suitability of the patient as a subject; Among them, A = 100-(10*m), A ≥ 80, excluding patients with more than 3 types of diseases; B ≥ 70%; C ≥ 60%; The P value sorting unit sorts the remaining patients according to the P value from large to small; The information processing unit, based on the number of subjects n1 determined by the researcher, notifies n2 patients to go to the hospital to sign relevant documents in person. The first n1 patients who sign officially become subjects; patients who do not meet the requirements are excluded; 3. Medication management module, including: The medication reminder unit, based on the medication plan list output by the program planning module, reminds the subject to prepare water in advance for medication 5 to 10 minutes before the set time and at the set time; each time the reminder reaches the set time, the total number of medications that should be taken is increased by 1, and the total number of medications that should be taken is updated; The drug storage module sets the storage temperature of the drug according to the drug storage requirements and stores the drug at an appropriate temperature; The sensing unit senses the weight of the water cup and transmits the information to the processor, which sends a start signal to the drug dispensing module when the set time is reached; The drug dispensing module starts dispensing the drug after receiving the start signal from the processor, and dispenses a fixed amount of the drug to the subject; Monitoring module: after the drug dispensing module finishes dispensing the drug, the processor sends a start signal to the monitoring module, and the monitoring module starts to collect video, shoots the process of the subject taking the drug, and transmits it to the processor; The processor performs image processing on the subject's medication process, captures the time point Tn when the subject's last medication action occurs under a single medication reminder and the number of medications K1, K2...K2 taken at each medication action; calculates the medication duration T=Tn-T1; calculates the sum of the number of medications Ksum=K1+K2...+Kn, and identifies it as the number of medications taken; determines whether the medication duration and the number of medications taken are both within the preset value range, if so, the current medication standard number of times is increased by 1, the current medication standard number of times is updated and sent to the medication compliance calculation unit; if not, the current medication standard number of times remains unchanged; Medication coordination calculation unit, calculates medication coordination H: H=Q / T*100% Among them, Q represents the current number of standard medication times, and T represents the total number of medication times that should be taken; Control H ≥ 85%, and exclude subjects with H < 85%; For subjects with H < 85% in communication unit B, the processor sends the reason through communication unit B and releases the subject identity, and records the number of subjects released d1; at the same time, the processor communicates with the data processing unit of the subject screening module, selects 1.2 to 1.5d1 patients with the highest P value among the unselected patients according to d1, and sends the subject selection information to the patient through communication unit A, prompting the patient to go to the hospital to sign the relevant documents in person, and the first d1 patients who sign officially become the supplementary subjects; 4. Biochemical index entry and supervision module, which enters the biochemical index information of the subjects. Researchers adjust the medication, eliminate or provide assistance to the subjects based on the biochemical index evaluation results.

Images