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Anti-blind area device and its use

A drug and clinical trial technology, applied in the field of medicine, can solve the problems of no new substitutes or method improvements, the inability to greatly improve the efficiency, and the adhesion of envelopes or sealed bags, so as to strengthen the monitoring of adverse drug reactions and unblinding Monitoring and management, good confidentiality performance

Inactive Publication Date: 2005-01-05
SECOND MILITARY MEDICAL UNIV OF THE PEOPLES LIBERATION ARMY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The entire process of making emergency seals includes writing group instructions, filling in the cover, sealing, etc. Most of them require manual labor by statisticians, which is time-consuming and laborious, and the efficiency cannot be greatly improved, especially when encountering a large number of experimental drugs, which seriously affects the progress of clinical research. ;If the sealing technology is not high, it is easy to cause adhesion between envelopes or sealed bags, affecting the appearance and unpacking; if the sealing is not strong, it is easy to cause blind bottom leakage
Second, if a serious adverse event occurs in a patient, it usually takes a certain amount of time for the clinician to open the emergency envelope by the investigator. In an emergency, they hope that the time is as short as possible.
However, so far, no new substitutes or method improvements have been reported.

Method used

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  • Anti-blind area device and its use
  • Anti-blind area device and its use
  • Anti-blind area device and its use

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] Embodiment 1, the emergency card emergency card (front) that compound famotidine chewable tablet is used for the clinical trial of acid-related symptoms:

[0036]

[0037] There is a scratch-off area in the emergency unblinding card, which is to print a layer of transparent oil on the shaded part of the upper text box "Test Group-Compound Famotidine Chewable Tablets", and apply another layer of oil after it dries. A layer of silver powder paint can be used after drying; when in use, just scrape off the silver powder paint with a slightly harder object, and the drug name below can be displayed.

[0038] Emergency card (back side):

[0039]

[0040] Emergency card (front):

[0041]

[0042] There is a scratch-off area in the emergency unblinding card, which is to print a layer of transparent oil on the shaded part of the upper text box "control group-famotidine tablets", and then coat it with a layer of silver powder after it dries. The lacquer can be used afte...

Embodiment 2

[0045] Embodiment 2, unblinding device with barcode——electronic unblinding card

[0046] The information content of the digitized electronic unblinding card includes the information required for clinical trials. The confidential content such as the drug name of the test group or control group accepted by the subject exists in the form of a barcode, and the rest of the information is printed on the card. above; the card reading control equipment used in conjunction with the electronic unblinding card is a computer, a management information system compiled with computer database software, and a corresponding barcode scanner. Through this scanner, the unblinding person can read the relevant information of the card barcode, At the same time, the management information system automatically records information such as the card number of the card, the time of reading the card, the number of reading times, and the person who unblinds it, as a record of unblinding, and locks the record....

Embodiment 3

[0049] Embodiment 3, real-time monitoring unblinding device with magnetic strip—real-time monitoring electronic unblinding card

[0050] The information content of the digitized real-time monitoring electronic unblinding card includes the information required for clinical trials, the title of the clinical trial and the notes for unblinding are printed directly on the surface of the card, and other contents include confidential content such as subjects accepting The drug names of the experimental group or the control group are digitally stored in the magnetic strip; the card reading control equipment used in conjunction with the card is a computer, a management information system compiled with computer database software, and a corresponding card reader.

[0051] When the computer is connected to the network, when the unblinding person reads the relevant information in the magnetic stripe of the card through the card reader, the management information system immediately notifies ...

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Abstract

The invention is a blind exposing device for clarify state of subject in medicine clinic research, the device includes information needed by the clinic experience and the information dress, it also includes control device with blind breaking recording function, it carries on blind breaking record when reading the digital or electron card or other similar objects. The device is applied to the emergent blind exposure in medicine clinic experience design, actualization and medicine estimation, it also can carry on remote monitoring to the blind exposure of the clinic research, at the same time, realizes the real-time transmission of relative data. The device has a good security, and it favors the monitoring and management to the blind exposure in clinic research.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a device for clinical drug research and its use, more specifically to a blinding device for drug clinical research and its use. Background technique [0002] The efficacy and safety of pharmaceutical products should ultimately be confirmed by clinical trials implemented in accordance with the principles of GCP (Good Clinical Practice). The purpose of clinical trials is to obtain a reliable and unbiased (Bias) demonstration of the proposed hypothesis. However, there are many difficulties in the evaluation of clinical trials of its medical effects. As mentioned above, the bias may come from every link from design to result analysis, or from the researchers, or from the subjects, or from the evaluators. aspect etc. Bias on the part of the investigator includes knowledge of whether the subject is using a new drug or an old drug, bias towards the new treatment, etc., which may produ...

Claims

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Application Information

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IPC IPC(8): G01N33/15G06F17/00
Inventor 贺佳陆健曹阳贺宪民马修强吴骋徐蕾孟虹
Owner SECOND MILITARY MEDICAL UNIV OF THE PEOPLES LIBERATION ARMY
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