Recently, the State Food and Drug Administration issued guidelines for the technical review of the registration of low-frequency electrotherapy devices, which stipulate the requirements that should be met in the clinical trials of low-frequency electrotherapy devices.
The clinical trial of the low-frequency electrotherapy device should meet the following requirements:
The clinical trial protocol should be reasonable, scientific, and able to verify the intended use of the product. The reasons for determining the number of clinical cases in the protocol should be sufficient and scientific;The scope of the selection should be clear and cover the intended use of the product;The clinical evaluation criteria should be clear and clinically recognized.
In general, the clinical trial protocol should include the following:Trial background, test purpose, research hypothesis, name and specification of the trial product, name, specification and selection reason of the control product, selection and exclusion criteria of patients, main efficacy evaluation indicators and evaluation methods, secondary efficacy evaluation indicators and safety evaluation indicators, sample size determination basis (including sample size calculation formula and its parameters**), follow-up period, trial quality control measures, data management methods, statistical analysis methods, and risk and benefit assessment of patients, etc.
The clinical trial report should meet the requirements of the protocol. The results of clinical trials should be clear, the measurement or counting results should be reliable, and statistical analysis should be performedThe clinical significance of the statistical results should be clarified in the analysis of the effect of the trialThe conclusion of the clinical trial should clarify the intended use of the product and be consistent with the purpose of the clinical trial.
The clinical trial report needs to be signed by the hospital and its content should be able to verify the intended use of the product. In general,The clinical trial report should include the following:Trial background, test purpose, research hypothesis, name and specification of the trial product, name, specification and selection reason of the control product, selection and exclusion criteria of patients, main efficacy evaluation indicators and evaluation methods, secondary efficacy evaluation indicators and safety evaluation indicators, sample size determination basis (including sample size calculation formula and its parameters**), follow-up period, trial quality control measures, data management methods, statistical analysis methods, and risk and benefit assessment of patients, etc.