Clinical trial of In vitro diagnostic reagents refers to the systematically study for in vitro diagnostic reagents performance in the corresponding clinical environment. Due to in vitro diagnostic reagents have the features of developing rapidly, the wide distance between fields of specialization, different intended use, so the clinical trial protocols are different for the products with different intended use. Applicant formulates the rational clinical trial protocol according to the feature and intended use of product. And CFDA has formulated and issued《The Technical Guidelines for In Vitro Diagnostic Reagents Clinical Trial》to make a guidance for applicant.
The clinical trial protocol should include the following in generally:
1.General information(including product information, clinical trial information about data, personnel and so on, relevant information of applicant)
2. Background Information of clinical trial
3. Clinical trial objective
4. Clinical trial design
Clinical method: If your product a newly developed: you should choose proper subjects, and use blinded simultaneous comparison to compare your product with gold standard of the disease diagnosis.
If your product has the same variety which has be marketed, your should choose proper contrast reagent and subjects.
- Sample size: You should determine the sample size and distribution according to intended use and occurrence rate of the relevant disease. And the size and distribution should conform to the minimum size requirement. For example, the sizes of Class III shall be 1000 at least, and the sizes of Class II shall be 200 at least.
5. Clinical trial evaluation
6. Statistical methods
7. Provisions for clinical trial correction
8. Ethical problems and explanation of clinical trial, informed consent (if so)
9. Data Processing and records retention
10. Other content necessary to explain
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