What should be included in the clinical placebo test report?

If the placebo is tested with the appearance of the test drug and the results need to be consistent, and the smell is also very different, the unique testing requirements of the bacterial test items and dosage forms, in short, are to remove the test items (such as identification and content) of the drug ingredients in the test drug, and the rest must be tested.

Placebo is an idea of additional empirical testing, and there is no specific method of operation. There are generally two ways to find placebo variables:

1) In the existing empirical tests, if the independent variable.

xi may affect the independent variable zi versus the dependent variable.

In the subsequent empirical test, the XJ variables of other subjects (same period, province, company) were used as placebo variables to test whether XJ affected the correlation between ZJ and YJ.

If there is no effect similar to XI, the placebo effect of XI can be ruled out.

2) As we all know, xi is a dummy variable.

xi=1，if t>t; xi=0,if tt+n；xi'=0, if t tests whether xi' affects the correlation between zi and yi, and if no similar effect is present, the placebo effect of xi is excluded.

If the appearance item of the test drug needs to be tested and the results need to be consistent, and the smell is also very different, the unique testing requirements of the bacterial test item and dosage form, in short, the test items (such as identification and content) of the drug components in the test drug are removed, and the placebo must be tested.

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Ps who has a good solution?

1.When there is no recognized effective intervention.

2.Helsinki Declaration: In the absence of proven prevention, diagnosis or ** methods", the use of placebo in the control group of a pilot study is acceptable, and usually in this case, placebo is more scientific than no intervention.

3.The Declaration of Helsinki adds that the use of a placebo control is necessary for compelling, scientifically sound methodological reasons to determine the effectiveness or safety of a preventive, diagnostic or advanced method, or when the prophylactic, diagnostic or preventive treatment of a disease is studied for a milder condition and the patient does not receive placebo without any increased risk of serious or irreversible harm.

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Your question is too general, and it might be more rewarding to go into more detail.

Placebo refers to a pill or preparation made of biologically neutral substances to make the subject or patient believe that it contains a certain drug, such as starch, a substance with no drug activity, which is made into the same dosage form as a real drug as a placebo. The placebo effect of the drug is produced through the cognition and feeling of the drug by the drug user, as well as the drug taking behavior itself, through the interaction between psychology and physiology. In short,"Placebo"The appearance is the same as that of a certain drug, but it has no pharmacological effect, and plays a leading role by influencing the patient's psychological factors.

Generally speaking, placebo is an adjunct in the course of clinical trials, which means that it is not used in daily life.

To put it bluntly, if I want to launch a new drug or health supplement, I have to obtain the corresponding clinical data. I will choose two groups of people, one group to take this drug or health supplement; In order to obtain comparative data, another group was given an unknowingly placebo in the same form as the first group's drug or supplement, but without any drug or health effect.

It is also used in new drug trials, where a placebo is injected into some people and a test drug is injected into another part. Participants do not know if they are receiving the actual test drug. So the mental state of the participants is the same.

Comparing the reactions of the two groups of people can see whether the drug has an effect or ***.

It is a medicine that comforts people who have hope for their condition when they have an incurable disease, but there is no specific medicine.

The difference between the clinical trial group and the placebo group is statistically prescribed.

When p is less than or equal to it, it indicates a significant difference, and the difference is statistically significant.

Not necessarily. If there is no clinically accepted method, placebo can be used, and if there is a standardized drug, it should be controlled with a positive drug.

Generally, the smell of the preparation is small, if the smell is large, the process of the preparation will correct the taste, and some of the odor comes from the excipients, which is better solved. View the original post

Search: In a double-blind trial prescribed by the GCP, the test drug is compared with a control drug or a placebo. They should all be consistent, how to understand and ask for the help of the great gods.

This role is called "researcher".