Traditional Culture Encyclopedia - Traditional virtues - Basic principles of clinical trial design
Basic principles of clinical trial design
The basic principles of clinical trial design include the principle of randomization, control, and blinding.
1. Randomization principle: Random means that the sample under study is randomly selected from the population under study. That is to say, when samples are drawn from the population under study, each observation unit must have an equal chance of being assigned to the observation group or group.
Control group.
Randomization can eliminate selection bias, that is, it can eliminate the bias in clinical research due to improper selection of research subjects that causes the research results to deviate from the true situation.
2. Control principle: In addition to the treatment factors to be studied, a group or several groups of cases with comparable non-treatment factors are selected for simultaneous observation, and then compared with the reference title.
The influence and bias of non-study factors can be controlled to determine whether the differences between the observation group and the control group are due to study factors.
The incidence of adverse reactions in clinical studies can be determined.
When selecting controls, attention should be paid to the balance between the control group and the observation group.
3. The blinding principle has three basic roles in clinical trials, namely subjects, performers and designers.
When one, two or three of them do not know which intervention the subject is receiving, this is called blinding.
The significance of blinding is to eliminate measurement bias.
Clinical trials are usually divided into four stages: 1. Preliminary exploration stage: This stage usually includes animal experiments and in vitro experiments to evaluate the potential efficacy and safety of the drug or treatment method.
2. Clinical Phase I trial: This phase usually evaluates the tolerability and safety of the drug or treatment method, and determines the optimal dosage and use of the drug.
3. Clinical phase II trials: This phase usually evaluates the efficacy and safety of the drug or treatment method, and studies the applicability of the drug or treatment method in a larger range of people.
4. Clinical phase III trials: This phase usually evaluates the efficacy and safety of the drug or treatment method in a large number of people, as well as comparative studies with existing treatments.
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