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Table of Contents
- What is the meaning of unblinding new drugs
- What is the statistical stage after unblinding?
- The principles of unblinding or breaking the blinding and Method
1. What does it mean to unblind new drugs
1. Unblinding of new drugs (English abbreviation DMC) means that during the clinical trial, after the researchers and the independent Data Monitoring Committee (DMC) evaluate a certain number of patients, the trial is suspended and Analyze the results. At this time, the trial researchers no longer have a blind understanding of the efficacy and safety of the drug, so it is called \”unblinding.\”
2. During the clinical trial, researchers need to observe the efficacy and safety of the drug on patients, but if they know which patients received the treatment and which Patients receiving a placebo may have cognitive biases in the trial results. Therefore, clinical trials need to be blinded, that is, controlled drug trials.
3. After a certain number of patients receive treatment, the Data Monitoring Committee (DMC) is responsible for analyzing the data to ensure patient safety and the scientific nature of the trial. . If the DMC finds that a drug has serious safety issues or has shown significant efficacy, they can choose to suspend the trial and \”unblind\” the drug type to researchers to better conduct follow-up work.
4. In short, unblinding new drugs is an evaluation mechanism for clinical trials. It aims to ensure the safety of patients, ensure the scientific conduct of trials, and help Researchers better assess the efficacy and safety of drugs.
2. What is the statistical stage after unblinding?
1. The \”statistical stage after unblinding\” refers to the process of unblinding the experimental group and the control group during the double-blind trial., stage for statistical analysis of test results.
2. Double-blind trials are a commonly used clinical research design designed to reduce subjective bias during the trial process. During the trial, there were personnel involved in the actual operation of the trial, but both the participants and the researchers were blind to the trial grouping (which participants belonged to the experimental group and which to the control group), as well as the evaluation and analysis of the experimental results. of. Only after all trials are completed, the blindness is lifted and statistical analysis of the results and data interpretation are performed.
3. Through the statistical stage after unblinding, researchers can compare the actual performance of the experimental group and the control group, and analyze the treatment reflected by the experimental results. Effects, side effects, safety and other related information. Statistical analysis after unblinding can help evaluate the efficacy and safety of drugs or interventions, thereby providing a basis for clinical decision-making and promotion.
3. Principles and methods of uncovering or breaking the blind
1 , Blinding (Blinding/Masking), a procedure in a clinical trial that makes one or more parties unaware of the subject\’s treatment allocation. Single blinding refers to the subject\’s ignorance, and double blinding refers to the subject, researcher, monitor or data analyzer. None were unaware of treatment assignment.
2. Random numbers, parameters for generating random numbers and experimental drug codes are collectively referred to as the blind base of double-blind clinical trials and are used to generate blinded random numbers. The time should be as close as possible to the time of drug distribution and packaging. The blinding process should have corresponding supervision measures and detailed blinding records. After the blinding is completed, the blind copy should be sealed in duplicate and submitted to the responsible unit for clinical research and the drug registration application respectively. People save.
3. In order for the doctor to know the medicines used by the patient in an emergency for rescue purposes, an emergency envelope with the patient number on the outside and the medicines used on the inside should be prepared. So that doctors can open it in an emergency, which is called emergency blinding.
4. In order to allow doctors to know in time what kind of medicine the patient is taking in an emergency, an \”emergency letter\” can be prepared.
5. The emergency letter includes the disease number and the name of the drug used. The emergency letter is sent to the researcher along with the distributed drugs. The emergency letter is a sealed letter. Open it. When writing an emergency letter, write the date, signature and reason for opening the emergency letter on the envelope and notify the principal investigator and sponsor immediately.
6. Conduct a blind review in accordance with the requirements of the statistical plan. During the blind review, consider whether certain subjects or certain data need to be eliminated; whether outliers need to be defined; whether certain influencing factors need to be added as co-factors in the statistical model. Variables. Any of the above decisions need to be documented. Decisions made under blind review should not be modified after unblinding. \”Mainly determine the analysis set.\”
7. After a blind review and the established database is deemed correct, the principal investigator, drug registration applicant, biostatistics professional and preservation The relevant personnel of the blind base locked the database. No further changes were allowed to the locked data files and the database was saved for future reference. Then the first unblinding was performed and the database was handed over to biostatistics professionals for statistical analysis.
8. After the statistical analysis is completed, the second unblinding is performed. This time, the unblinding indicates which of the two groups A and B is the experimental group.
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