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Clinical Pharmacology

Release Date:2014-06-13



Since 1980s’ Professor Gu Niufan, a renowned clinical pharmacologist, has begun to systematically carry out the study on clinical psychopharmacology, including efficacy and safety assessment of the psychotropics, ADR monitoring, pharmacokinetics studies, drug concentration detection etc. In 1986, SMHC became the cooperative hospitalofClinical Pharmacology Research Base,ShanghaiMedicalUniversity.

Under the leadership of Prof. Gu SMHC was appointed as one of the first batch of ‘State Base for Drug Clinical Trials’ by Ministry of Health, PRC in 1998, and renamed ‘Medical Institution Conducting Clinical Trails for Human Used Drug (MICT)’ in Psychiatry and Phase I by SFDA in 2009. The Independent Ethics Committee, SMHC was founded and registered in Office for Human Research Protections (OHRP), United States Department of Health and Human Services.

We have an integrated organization and a well-experienced research team of clinical trials, including principal investigators(PI) of  different specialized fields, clinical research coordinators(CRC), sub-investigators(SUB-I), research nurses, research pharmacists, quality assurance(QC) team, data management, statisticians and so on. MICT can meet the requirements of international clinical trials and domestic clinical trials for new drugs with independent intellectual property rights. Rules, regulations, SOPs and quality management systems have been set up and well implemented in decades. Many clinical trails performed have been registered in the ClinicalTrials.gov.

More than one hundred clinical trials have been completed so far, including antidepressants (Fluoxetine, Paroxetine, Fluvoxamine, Citalopram, Escitalopram, Sertraline, Mirtazapine, Venlafaxine, Tianeptine, Bupropion, Reboxetine, Duloxetine, St.John wort, Milnacipran, Agomelatine, Chinese medicine etc.), antipsychotics (Risperidone, Quetiapine, Olanzapine, Ziprasidone, Aripiprazole, Sertindole, Paliperidone etc.), anti-anxiety drugs (Tandospirone, Ethyl Loflazepate, Buspirone hydrochloride etc.), sedative hypnotics (Zaleplon, Midazolam, Zopiclone, Zolpidem, Brotizolam,Chinese medicine etc.), nootropic drugs (Huperzine A , Nefiracetam, Galantamine, Donepezil, Rivastigmine, Rosiglitazone, Memantine, Chinese medicine etc.), mood stabilizers (Topiramate, Risperidone, Quetiapine, Olanzapine, Paliperidone, Aripiprazole, Lithium carbonate etc.) and psychotropics for children (Methylphenidate, Atomoxetine, Clonidine patch etc.). Among which there are 21 international multi-center clinical trials, 7INDclinical trails and 14 Phase I clinical trails. MICT, SMHC acted as leading coordinator about 78% of registered clinical trails and was audited for 6 times and highly rated by multinational pharmaceutical companies. 

In 2008 with the support of SMHC, Professor Li Huafang, current director of MICT Office, successfully got the funding of ‘National Major Projects for investigational new drug (IND)’ from the Ministry of Science and Technology, PRC, which is a project supporting the establishment of new drug evaluation technology platform. MICT, SMHC is the only psychiatry tech-platform in the country with the total investment of 11 million RMB (US$ 1.7 million). Since then, ‘the human biomedical research ethics committee’ in line with international norms has been established. ‘Guidelines on Drug Clinical Trials in Psychiatry’ in accordance with EMEA and FDA standards have been developed and published in order to standardize the design and evaluation technique of clinical trials inChina. Phase I ward, Phase I laboratory, the electronic data management system and the quality management system have been updated. Three researchers of MICT had already gotten the certifications on CPI and CRC of Association of Clinical Research Professionals (ACRP). Several researches of new evaluation indicators for clinical trials have been carried out. The achievements of the technology platform are widely recognized and they could become the models of clinical trials inChina. 

The phase I ward, which has 400 square meters with 24 beds, includes sampling room, sample processing room, emergency room, living room, intensive care unit and the duty room. It is equipped with advanced and necessary facilities for phase I clinical trials such as electrocardiogram machine, ventilator, ECG monitor, defibrillator, gastrolavage machine, time synchronization display systems, surveillance systems and call systems.

Many highly professional researchers of MICT, such as Prof. Gu Niufan, Prof. Zhao Min, Prof. Xiao Shifu and Prof. Li Huafang etc. are members of the Chinese Pharmacopeia Committee or consultants of Center for Drug Evaluation, SFDA. They have made outstanding achievements in the fields of medical treatment, teaching, research or management.

Clinical TrialTrainingCenterof SMHC has been established to promote training courses on clinical trails and psychopharmacology for related practitioners inChina. It is also a base for training graduate students. Having insisting on the philosophy-"Quality-driven & Safety-based" for many years, MICT has earned high reputation at home and abroad. Our aim is to build the best clinical practice inChinawhich meets the international standards. We are interested in participating more global clinical trials, leading more clinical trials of new drugs with Chinese independent intellectual property rights, expanding the indicators and training more professionals.


Contact Us:

Director: Li Huafang                 Tel. +86 21 34289888-3128

Secretary: Shen Yifeng               Tel. +86 21 34289888-3215

CRC: Wang Zhiyan, Li Yan, Yu Yimin  Tel. +86 21 34289888-3122

Study Pharmacist: Yan Xiaolei         Tel. +86 21 34289888-3122

Study Nurse: Su Dongjun             Tel. +86 21 34289888-3122

 

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