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