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With the introduction of policies such as "self-checking of clinical trial data" and "conformity evaluation of the quality and efficacy of generic drugs", the attention of clinical trials has been increasingData from the Drug Clinical Trial Registration Platform has also increased year by year, with a total of 9730 clinical trials for CTR as of December 27, 2019Figure 1: Clinical Trial Registration Platform StatisticsClinical Trial Analysis published in 2019
2013 Notice No28, to obtain approval of a drug clinical trial, the applicant must complete the pre-registration of the trial within 1 month after approval, in order to obtain the test unique registration numberHowever, some pharmaceutical companies have not perfected and made public clinical trial information after obtaining the registration number, so the author will conduct a comprehensive analysis of the 2152 clinical trials published before December 27, 20191, 2019 clinical trial phase2019 clinical trial phase of the highest proportion of "other" up to 52%The reason for this is that with the development of the evaluation of the quality and efficacy consistency of generic drugs, the registration of bioequivalence/bioavailability test increased, and the "other" phased test type statistics were carried out, and the proportion of bioequivalence/bioavailability tests reached 47%Figure 2: Drug Clinical Trial phase2, domestic trial series and international multi-center trials
the current drug clinical trial platform in the clinical trial spree mainly domestic trials, a total of 150 international multi-center trials in 2019, an increase of 20% year-on-yearOf these, 89 were tested in Phase III, accounting for 59.3%Figure 3: Domestic and international multi-center tests
Qingdao Baiyang Pharmaceutical Co., Ltdand Hainan Puli Pharmaceutical Co., Ltdcarried out the largest number of international multi-center trials, respectively, carried out 8 multi-center tests, both bioequivalence testsTable 1: Qingdao Baiyang Pharmaceutical Co., LtdInternational Multi-Center TrialTable 2: Hainan Puley Pharmaceutical Co., LtdInternational Multi-Center Trial3, 2019 Clinical Trials of the most concerned drugclinical trial registration statistics found that the most concerned drugs in 2019 are metformin reprieve, followed by Amoxicin capsules and TQB2450 injectionFurther analysis of statistics found that the most concerned drugs IN TOP10 8 are carried out bioequivalence testsOverall, this is down from 2018, mainly due to a decrease in the number of clinical trials related to consistency evaluationTable 3: Top204, the most highly watched clinical trial drug in 2019, the most active business espresso in clinical trial registration in 2019
overall, clinical trial registration in 2019 and the overall strength of each enterprise is positively correlatedThis statistic is not based on the parent company statistics, the subsidiary independent calculationJiangsu Hengrui has the largest number of clinical trial registrations, followed by Zhengda Tianqing PharmaceuticalsHowever, Zhengda Tianqing and Hengrui Medicine differ in that the majority of the clinical registration of Zhengda Tianqing is bioequivalence test, while Jiangsu Hengrui is to pharmacokinetics / pharmacokinetics test in the majorityTable 4: The most active clinical trial registration in 2019
5, the most popular clinical trial institution spree in 2019
the most clinical trial institutions conducted in 2019 is the Shanghai Public Health Clinical Center and the Chinese Academy of Medical Sciences Oncology Hospital, the number of clinical trials are 55 The number of clinical trials at the Shanghai Public Health Clinical Center decreased by 52.17% from 2018 to 115 in 2018 Overall, the number of clinical trials undertaken by clinical trial institutions decreased overall, mainly due to a decrease in the number of clinical trials related to consistency evaluation According to statistics, the number of clinical trials related to consistency evaluation decreased by 36.19% compared to 2018 Table 5: The most popular clinical trial institutions in 2019
the above summary: Looking at the 2019 registered clinical trials, it can be found that the proportion of BE trials is larger, large pharmaceutical companies have a large number of clinical trials this paper data from the pharmaceutical data, CDE drug clinical trial registration and publicity platform.