Study On The Current Situation Of The Registration Of Diabetes Drugs In China

ObjectivesThrough access to the contents of the register database on www.Clinadrug Trials.org.cn,this thesis summarized and analyzed the clinical trials of China’s diabetes and its complications from2013 to 2019 in order to understand the research progress of clinical trials of anti-diabetic drugs in China and the research status of innovative and generic anti-diabetic drugs in China,and provide research directions for the further development of clinical trials of anti-diabetic drugs.Secondly,through the research of clinical trial cooperation network,summarize the regulars of institutional cooperation,expected to provide data support and reference for pharmaceutical companies and personnel who need to carry out clinical trials of drugs for diabetes or its complications in China in the future.MethodsFirst,the thesis used octopusextraction to collect the clinical trials data on www.Clinadrug Trials.org.cn.Then it used Excel to process data and analyzed the clinical trial registration number,test status,the sponsor,the regional distribution of the clinical test units and participants in the test quantity,and so forth.Next,it referred to the official website of National Medical Products Administration and the public information of the Drug Intelligence Data Network,and sorts out the marketing information of anti-diabetic drugs in China.Finally,Gephi-0.9.2 software was employed to visualize and analyze the cooperative relationship between clinical trial sponsors and clinical trial institutions,among clinical trial institution.ResultsFrom 2013 to 2019,a total of 751 clinical trials of diabetes and its complications were registered on www.Clinadrug Trials.org.cn.705 trials were carried out in China,including 356 bioequivalence trials,the number of phase I trials 186,the number of phase II clinical trials 43,and the number of phase III clinical trials 100,the number of phase IV clinical trial just 1,and19 others.The clinical trial phase is relatively concentrated.Domestic trials were the majority,while international multi-center cooperation was only 46.In recent years,clinical trials of diabetes in China mainly focus on studying oral hypoglycemic drugs with new mechanisms,and breakthroughs have been made in researching innovative drugs and generic drugs.A variety of hypoglycemic drugs have been marketed or submitted for marketing.The proportion of clinical trial institutions is small,and the distribution and development are unbalanced.Most of the clinical trial institutions were concentrated in the eastern region,but few in the western region.The First Affiliated Hospital of Anhui Medical University,West China Hospital of Sichuan University and other clinical trial institutions were more active and participated in more trials.The cooperation among institutions in drug clinical trial increased,and the cooperation among institutions showed regional characteristics.The sponsor’s choice of the group leader for the pilot study is relatively fixed.ConclusionPharmaceutical enterprises should speed up the independent research and development of diabetes drugs with new mechanisms according to the trend of drug research and development.When carrying out multi-center clinical trials,selecting the right group leader and making good use of "pivot" institutions can promote the common progress of clinical trial institutions and promote the high quality of multi-center clinical trials...