Transcript Clinical Research and Clinical Trials in Switzerland

Center for Clinical Research Clinical Trials Center (CTC)
Clinical Research and
Clinical Trials in Switzerland
Jürg Lustenberger, PhD
Dipl. Pharm. Med. SwAPP, MRQA
Head QM, CTC, University Hospital and University Zurich;
CEO & GCP/GMP Auditor and Consultant, SwissPharmAudit
Center for Clinical Research Clinical Trials Center (CTC)
Overview
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Clinical Research in Switzerland

IITs – SCTO – CTUs
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Regulatory Background – Switzerland and Europe
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Center for Clinical Research Clinical Trials Center (CTC)
Clinical Research in Switzerland
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Regulated by laws and ordinances (medicinal products
and medical devices)
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Industry sponsored trials and Investigator Initiated Trials
(IITs) regulated in the same way
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Swissmedic, BAG = Regulatory Authorities
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236 trials submitted to Swissmedic in 2011
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17 inspections in 2011, 6 of them at Clinical Trial Units at
Universities in Switzerland
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Center for Clinical Research Clinical Trials Center (CTC)
Clinical Research in Switzerland
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Investment in switzerland
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Center for Clinical Research Clinical Trials Center (CTC)
Clinical Research in Switzerland
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Center for Clinical Research Clinical Trials Center (CTC)
Clinical Research in Switzerland
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Pharma Industry does support IITs
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Public institutions and programmes are supporting IITs:
 Bilateral Science and Technology Cooperation
Programmes
 Research credits/grants of Universities
 Swiss National Science Foundation (SNSF)
 The Human Frontier Science Program HFSP
 European Research Council
 CTI – the commission for technology and innovation
 etc.
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Center for Clinical Research Clinical Trials Center (CTC)
Objectives of IITs
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Optimising existing medicinal products, therapies,
diagnostic techniques and surgical procedures
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Evaluation of treatment strategies for orphan diseases
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Exploring efficacy of marketed drugs in new indications,
populations and/or conditions
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Answers to questions from clinical practice
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Center for Clinical Research Clinical Trials Center (CTC)
CTU St. Gallen
CTU Basel
CTU Zurich
CTU Berne
CTU Lausanne
CTU Geneva
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Center for Clinical Research Clinical Trials Center (CTC)
Clinical Trials Units (CTUs)
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Support primarily „Investigator Initiated Trials“ (IITs)
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Consult clinics, institutes and hospitals in regard to
clinical trials
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Support research in international networks
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Set up and maintenance of quality management system
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Implementation of web-based data management
system
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Responsible for education in clinical research
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Center for Clinical Research Clinical Trials Center (CTC)
Regulatory Background – Switzerland
Federal Act on Medicinal Products and Medical Devices
(Therapeutic Products Act, TPA of December 2000)
Ordinance on clinical trials of therapeutic products
(VKlin / Oclin of October 2001)
Ordinance on medical devices (MepV of October 2001)
Clinical trial: Any trial carried out on human subject with the
intention of systematically verifying the safety, efficacy or
other properties of a therapeutic product or its bioavailability.
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Center for Clinical Research Clinical Trials Center (CTC)
Regulatory Background – Europe
Directive 2001/20/EC
(GCP directive)
Directive 2005/28/EC
90/385/EEG (AIMD)
93/42/EEG (MD)
98/79/EG (IVD)
2007/47/EG (amending
93/42/EEG, 90/385/EEG)
Guidelines (MEDDEVs, ISO
14155:2011)
Regulations in EU countries
(Laws, ordinances)
Regulations in EU countries
(Laws, ordinances)
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Center for Clinical Research Clinical Trials Center (CTC)
Regulatory Background – Europe, Switzerland
Outlook
 New drafts of or updated regulations available since 2012
 Generally, change towards risk adapted evaluation of
clinical trials, harmonised procedures with less
administrative and cost burdens, use of public registers
 Europe: Directive 2001/20/EC planned to be updated until
2016 (including change into regulation)
 Switzerland: new regulation «Humanforschungsgesetz»
(Human Research Act) in force beginning of 2014
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Center for Clinical Research Clinical Trials Center (CTC)
Regulatory Background – Europe, Switzerland
Outlook
 Switzerland: first drafts of ordinances were released by
BAG beginning of September
 Ordinance on clinical trials (HFV1)
 Ordinance on non-clinical trials (HFV2)
 Ordinance on organisation (OV-HFG)
 Review process by interested parties with comments back
to BAG until end of October 2012
 Switzerland ahead of Europe which can be an advantage
in regards to clinical trials
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Center for Clinical Research Clinical Trials Center (CTC)
Regulatory Background – Europe, Switzerland
Risk Categorisation
Research with
human beings
In Switzerland
Non-Clinical
Trial
Clinical Trial
IMP
Medical Device
Transplantation
Health
Intervention
Category
A, B or C
Category
A or C
Category
A or C
Category
A or B
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Risks = minimal
Risks > minimal
Center for Clinical Research Clinical Trials Center (CTC)
Regulatory Background – Europe, Switzerland
Consequences in Switzerland
 Compatibility with international requirements
 Registration of the trials in public registers
 Faster evaluations of clinical trials adapted to their risks
 Quality management measures adapted to the assessed
risk should be implemented
 Better regulation of research with biological material and
health data
 In general, clinical research will benefit
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Center for Clinical Research Clinical Trials Center (CTC)
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