Is the research result of the hottest clinical tri

2022-08-08
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Whether the research results of clinical trials are consistent

the multicenter clinical pharmacological trial of endocrine drugs is a clinical trial conducted by multiple research units at the same time according to the same scientific test plan. Its purpose is to evaluate the efficacy and safety of this drug and provide information basis for the decision-making of pharmaceutical leading departments, For doctors at all levels "You see, this variable-frequency pump in my hand provides guiding opinions for drug use. The requirements and organization and implementation of multicenter trials in all aspects are more complex. We must strictly comply with China's drug clinical trial management norms, and be scientific, ethical and legitimate. First, we must maintain scientificity from beginning to end, that is, to ensure that the clinical trial process is standardized and reliable, the data is complete, accurate, and the results are objective and credible. Many There are certain operating procedures for cardiac clinical trials. The main researchers drafted the test plan and obtained the consent of the sponsor. After the drafting of the test plan and its annexes, the main researchers of each center should be convened to discuss, modify and determine. The research principals of all centers must participate in this meeting for mutual consultation. Once the test is started, the test plan cannot be changed. Before the clinical trial, the researchers who participated in the trial were trained to explain the details in detail, and appropriate management measures were established to make the researchers in each trial center comply with the trial plan. If necessary, organize one or several researcher meetings at the mid-term of the clinical trial to discuss the existing problems and propose improvements and remedies. At the same time, the evaluation methods should be standardized. The targeted methods of laboratory and clinical evaluation and policy resources used in the trial should have quality control standards, or the collected samples should be sent to a central laboratory for determination Specimens should be collected on time, stored properly, and transported to the central laboratory safely. If the content of chemical carbon fiber and polypropylene fiber is 45% and 55% respectively, and the test is carried out in each center, the instruments and equipment used, the determination procedures and the kits used should be consistent. The main research unit can send samples with known values to the laboratory of each center for testing to monitor whether the test results of each center are consistent

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