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Technical Guidelines for Clinical Trials of in Vitro Diagnostic Reagents

1. Scope of application of in vitro diagnostic reagents

Clinical trials of in vitro diagnostic reagents refer to systematic research on the clinical performance of in vitro diagnostic reagents in a corresponding clinical environment. The purpose of clinical trials is to prove that in vitro diagnostic reagents can meet the requirements of the intended use, and to determine the applicable population and indications of the product. The results of clinical trials provide effective scientific evidence for the confirmation of the safety and effectiveness of in vitro diagnostic reagents and the analysis of risks and benefits.

In vitro diagnostic reagents provide test results through in vitro testing of human samples, which are used alone or together with other information to assist in judging the target state of the subject (health state, disease state, disease process, or other diseases/health states that can be used to guide clinical treatment, etc. ). The "clinical performance" of an in vitro diagnostic reagent refers to the ability of an in vitro diagnostic reagent to be used by the intended user in the intended environment, and to obtain test results related to the target state of the subject for the target population. Due to the characteristics of rapid development, wide professional span and different clinical intended uses of in vitro diagnostic reagent products, the clinical trial methods and contents of different products are not the same.

2. Basic principles of in vitro diagnostic reagents

(1) Ethical principles

The clinical trials of in vitro diagnostic equipment should follow the ethical guidelines of the Declaration of Helsinki of the World Medical Assembly and the relevant requirements of the national biomedical research ethics involving human beings, and should be reviewed and agreed by the ethics committee. Researchers need to consider the risks of obtaining samples for clinical trials, such as blood, urine, sputum, cerebrospinal fluid, feces, vaginal secretions, nasopharyngeal swabs, tissue sections, bone marrow, amniotic fluid, etc., and the test results to the subjects. Submit to the ethics committee for review to ensure that the clinical trial will not place the subjects at unreasonable risks and obtain the informed consent of the subjects as required.

(2) Scientific principles

The development of clinical trials should be based on preclinical research, with sufficient scientific basis and clear test purposes. Clinical trials should be scientifically designed based on the intended use of the product, the epidemiological background of the relevant disease, and statistical requirements, while at the same time maximizing the control of experimental errors, improving the quality of the trial, and conducting scientific and reasonable analysis of the trial results. While ensuring that the test results are scientific, accurate and credible, it is as efficient, fast and economical as possible.

(3) Principle of law

This guideline is formulated under the regulatory framework of the Regulations on the Supervision and Administration of Medical Devices, the Administrative Measures for the Registration and Filing of In Vitro Diagnostic Reagents, and the Good Clinical Practice for Medical Devices. The development of clinical trials of in vitro diagnostic equipment should comply with the requirements of relevant laws and regulations.