The data set obtained after the least and most fair elimination of the data of all randomized subjects according to the intention-to-treat analysis principle

Should include all subjects who have used study drugs after randomization and have partial efficacy evaluation data

For the main efficacy indicator, if the case data of the entire treatment process cannot be observed, the last observed result can be carried forward to the end of the trial (last observation carry forward, LOCF). The number of subjects in each group who evaluates the efficacy at the end point. Be consistent with the start of the trial

Intention-to-treat analysis (ITT): All patients who have been randomized should be followed up, evaluated and analyzed according to the assigned treatment group, regardless of whether they comply with the planned treatment process, not according to the actual treatment group. Accepted treatment groups for analysis to maintain randomization results

The estimated value of the primary endpoint indicator and its standard deviation: query the literature or estimate based on the results of previous studies and preliminary experiments. Quantitative - collect the expected mean and standard deviation; Qualitative - collect the expected incidence rate or percentage

Clinical boundary value: Δ is the difference in efficacy between the test group and the control group. It cannot exceed the maximum clinically acceptable difference range and should be smaller than the difference that can be observed in the superiority test of the positive control drug over the placebo. It should be determined by Given by a clinician or expert in the field

Test level: Type I error probability α, the probability of incorrectly rejecting the null hypothesis

Test efficacy: Power, when the alternative hypothesis is correct, the possibility of accepting it through statistical inference. When the experimental group is truly effective, the probability that the experimental group can be concluded to be valid through one sampling. 1-β should be at least 80%

Classification indicators

Metrics

Classification indicators

Metrics

An important part of ensuring complete and accurate data collection and quality of clinical research

It is an important means of obtaining research data in clinical research and a carrier for collecting, recording and preserving experimental data; it can be used as an original record for scientific research archive preservation; it can provide original data to facilitate statistical analysis; it can facilitate verification by the health administration department

Follow clinical study protocols

Comprehensive and complete, concise and to the point

Easy to understand and easy to fill in

Facilitates data entry and statistical analysis

The order of questions should be logical

The setting of options should be comprehensive and reflect the purpose of the research

Related question settings

Coding settings should be unified

Please indicate how to handle unknown situations when filling out the form.