Center for Clinical Research -
Clinical Trials Center (CTC)
Clinical Research and Clinical Trials in SwitzerlandJürg Lustenberger, PhDDipl. Pharm. Med. SwAPP, MRQA
Head QM, CTC, University Hospital and University Zurich; CEO & GCP/GMP Auditor and Consultant, SwissPharmAudit
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Center for Clinical Research -
Clinical Trials Center (CTC)
Overview
Clinical Research in Switzerland
IITs – SCTO – CTUs
Regulatory Background – Switzerland and Europe
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Center for Clinical Research -
Clinical Trials Center (CTC)
Clinical Research in Switzerland
Regulated by laws and ordinances (medicinal products and medical devices)
Industry sponsored trials and Investigator Initiated Trials (IITs) regulated in the same way
Swissmedic, BAG = Regulatory Authorities
236 trials submitted to Swissmedic in 2011
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
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
Pharma Industry does support IITs
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
Optimising existing medicinal products, therapies, diagnostic techniques and surgical procedures
Evaluation of treatment strategies for orphan diseases
Exploring efficacy of marketed drugs in new indications, populations and/or conditions
Answers to questions from clinical practice
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Center for Clinical Research -
Clinical Trials Center (CTC)
CTU Geneva
CTU Berne
CTU BaselCTU Zurich
CTU St. Gallen
CTU Lausanne
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Center for Clinical Research -
Clinical Trials Center (CTC)
Clinical Trials Units (CTUs)
Support primarily „Investigator Initiated Trials“ (IITs)
Consult clinics, institutes and hospitals in regard to clinical trials
Support research in international networks
Set up and maintenance of quality management system
Implementation of web-based data management system
Responsible for education in clinical research
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Center for Clinical Research -
Clinical Trials Center (CTC)
Regulatory Background – Switzerland
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.
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)
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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
Regulations in EU countries
(Laws, ordinances)
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)
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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)
Research with human beings
Clinical Trial
IMP
Category
A, B or C
Medical
Device
Category
A or C
Transplan
tation
Category
A or C
Health
Intervention
Category
A or B
Non-Clinical Trial
Risks = minimal Risks > minimal
Regulatory Background – Europe, Switzerland
Risk Categorisation
In Switzerland
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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)
Thank you for your attention