The Center for Clinical Trials of Drugs and Medical Devices

Transcription

1 Siberian State Medical University maintaining traditions to develop the medicine of the future The Center for Clinical Trials of Drugs and Medical Devices SIBERIAN STATE MEDICAL UNIVERSITY O.S. Kobyakova rector of SSMU, DMedSc, professor

2 Siberian State Medical University: History Over the past 100 years we ve trained: over doctors and pharmacists; over specialists certified SSMU graduates: over 800 MDs, 42 academicians, 25 associate members of the Russian Academy of Medical Sciences, 2 presidents of the Russian Academy of Medical Sciences (Nikolai Burdenko, Vladimir Timakov) SSMU graduates: Healthcare Minister ASFSA Anatoly Potapov Deputy Minister of Education and Science of the RF Lyudmila Ogorodova 127 Years of medical education in the Asian part of Russia

3 Siberian State Medical University: Education Departments: General Medicine General Medicine Dentistry Pediatrics Pharmacy Biomedicine Biochemistry Biophysics Medical Cybernetics Behavioral Medicine and Management Department Clinical Psychology Social Work Health Care Management Advanced Training and Postgraduate Education FAST FACTS: Over 5500 students 55 regions of the Russian Federation 13 foreign countries Over 80% students from all over Russia 40% - employersponsored education, incl. healthcare system of Tomsk region Over 80% Faculty with Academic Degrees (375 DMedSc)

4 Accreditation 1. Medical license ФС dated Accreditation of Phase II-IV until Accreditation of Phase I 4. Accreditation of clinical trials of medical devices

5 Local Ethics Committee Established in 2002 Operates in accordance with the national standards of the Russian Federation "Good Clinical Practice - Good clinical practice (GCP) GOST R and their own standards of operating procedures Provides ethical review and ethical support of all clinical trials conducted at SSMU Performs selective audit of clinical trials

6 The Clinical Trials Center and Clinical Facilities Siberian State Medical University has its own 858 bed hospital Clinical departments of SSMU are located in 13 medical organizations of Tomsk region with modern diagnostic and medical equipment SSMU Hospital Internal medicine clinic Specialized medicine clinic Endocrinology clinic Children hospital Gynecology clinic Neurology clinic General surgery clinic Intensive surgery clinic Infectious diseases clinic Ophthalmology clinic

7 Principal Investigators Over 20 principal investigators The average medical experience of the PI 24 years The average CT experience of PI - more than 4 CTs 100% of the principal investigators and 85% of co-researchers have a GCP The research team generally consist of 5 investigators CT scope: gynecology, pulmonology, allergy and immunology, neurology, urology, infectious diseases, cardiology, endocrinology and diabetes, pediatrics, surgery, pediatric surgery, gastroenterology, hematology, internal medicine

8 Inspection and Audit Federal Service for Supervision in Healthcare Healthcare Ministry of the Russian Federation Audit certificates with the absence of findings (audits did not reveal Major or Critical Finding), 2011,2012 No serious findings during scheduled and unscheduled inspections (continuous monitoring)

9 Major Clients Pfizer Worldwide Clinical Trials PAREXEL PPD (Smolensk) GlaxoSmithKline PSI Vector Medica Johnson & Johnson Boehringer Ingelheim BioCryst Pharmaceuticals, Inc. Merck Sharp & Dohme Idea Inc. (MSD) Kendle clinical Development Andromeda Biotech Ltd. Eli Lilly and Company Farmanet Synergy Research Group Quintiles Janssen Pharmaceuticals Mundifarma Research Ferment Sava UfaVita Alvils

10 Medical Training for Researchers "Good Clinical Practice. Evidence-based medicine and methodology of clinical trial planning. a course (72 hours) developed in 2012 Long-distance access (e-learning) Accessible any time anywhere No need to take time off work Possible to plan the time and duration of involvement Possible to return to the covered material while taking the course

11 Collaboration Proposal Services for conducting clinical trials of drugs (I-IV phase) Services for clinical trials of medical devices Services for documentation preparation for clinical trials: investigator's brochure research protocol informed consent form statistical analysis study report Medical training for researchers Julia G. Samoilova, DMedSci, prof., Head of the Clinical Trials Center, SSMU Tel.: 8 (3822) ; +7 (913) Tomsk, Moskovsky trakt, 3g, Central RnD Lab center.clin.iss@ssmu.ru Contacts Evgeny S. Kulikov, DMedSci., Head of Science and Research Division, SSMU Tel.: 8 (3822) , ext (906) Tomsk, Moskovsky trakt 2, upr.nauch@ssmu.ru

12 SSMU Clinical Trials Fast Facts >150 clinical trials I-IV Phase CCT/LEC quality control 858 Beds in SSMU Hospital 100% GCP certified 13 Clinical facilities at medical organizations > 20 Principal Investigators 85% GCP certified

13 Siberian State Medical University maintaining traditions to develop the medicine of the future The Center for Clinical Trials of Drugs and Medical Devices SIBERIAN STATE MEDICAL UNIVERSITY O.S. Kobyakova rector of SSMU, DMedSc, professor

14 Principal Investigators Principal Investigator Degree Experie nce (Phase) Number of CT Scope Ageeva Tatyana DMedSc I-IV 2 pulmonology, internal medicine, cardiology Alifirova Valentina DMedSc II-IV >10 neurology Bukreeva Ekaterina DMedSc II-IV >10 pulmonology, internal medicine Beloborodova Ekaterina DMedSc III-IV 5 gastroenterology, internal medicine Vorozhcova Irina DMedSc III-IV 2 cardiology, endocrinology Evtushenko Irina DMedSc II-IV 5 gynecology Gudkov Alexander DMedSc III-IV 2 urology Zhukova Natalya DMedSc III-IV 2 neurology Idrisova Elenf DMedSc III-IV 7 Internal medicine, cardiology

15 Principal Investigators Principal Investigator Degree Experie nce (Phase) Number of CT Latypov Victor DMedSc III-IV 3 surgery, urology Scope Poponina Tatyana DMedSc III-IV 5 cardiology Samoylova Julia DMedSc I-IV >10 Endocrinology and diabetes Starovoytova Elena PhD II-IV 8 pulmonology, internal medicine, cardiology, allergy and immunology Slozovsky Gtigory DMedSc III-IV 1 pediatric surgery Tuteva Elena PhD III-IV 5 pediatrics Chuykova Kira DMedSc III-IV 7 infectious diseases Fedorova Olga DMedSc II-IV >10 pulmonology, internal medicine, pediatrics, allergy and immunology