[exclusive] mid year report of 2018 domestic clinical trial

With the introduction of "self inspection and verification of clinical trial data" and "consistency evaluation of quality and efficacy of generic drugs" and other policies, the attention of clinical trials has been increasing In the first half of 2018, a total of 880 clinical trials were publicized on the CDE drug clinical trial registration platform Among them, 670 are chemical drugs, 154 are biological products, and 26 are traditional Chinese medicine / natural medicine At present, most of the clinical trials in the drug clinical trial platform are domestic trials In the first half of 2018, there were 55 international multicenter trials, 54 of which were phase 2 and phase 3 trials, mainly focusing on safety and effectiveness From the drug point of view, 55 are clinical trials of new drugs In the international multicenter trial, except for bgb-a317 injection of Baiji Shenzhou, most of the trials were conducted by foreign companies According to the total number of clinical trials registered monthly (CTR number obtained), the number of clinical trials registered increased significantly in the first half of 2018, among which 207 clinical trials were registered in May We can see the classification and stage of the trial I don't do much analysis here, mainly because the development of consistency evaluation is different from the regular clinical trial registration rules In the first half of 2018, the top 10 drugs most concerned in the clinical trials in the trial classification trial stage statistics found that the most concerned drugs in the first half of 2018 were metformin hydrochloride tablets and Amoxicillin Capsules, followed by amlodipine besylate tablets Further analysis showed that the top 10 drugs of most concern had 158 trials, of which 149 were bioequivalence trials, accounting for 94.3% Table 1: the busiest clinical trial institutions of top 10, the most concerned clinical trial drugs Finally, take a brief look at the busiest clinical trial institutions in the first half of 2018 The Shanghai Public Health Clinical Center conducted the most trials I still think that the state should establish a number of professional clinical trial institutions, independent of hospitals In addition, there should be some policy inclinations for hospital doctors to carry out clinical trials, such as professional title evaluation To sum up: looking at the published clinical trials in the first half of 2018, it can be found that bioequivalence trials account for a large proportion, and professional clinical trial institutions undertake more clinical trials The data of this paper comes from CDE drug clinical trial registration and publicity platform and drug intelligence China clinical trial database.