Benefits and Risks of Research: How Do We Redress the Current Imbalance?

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Matilda Goodwin
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1 EFGCP Annual Conference 2014 Benefits and Risks of Research: How Do We Redress the Current Imbalance? 28 & 29 January 2014 Renaissance Brussels Hotel, Brussels, Belgium Organised by the European Forum for Good Clinical Practice In partnership with

2 Conference Rationale The risks and benefits of research remain a central consideration in drug development, research design, review and regulation. It s consequently a central concern within the new proposed EU Clinical Trial Regulations. Yet there is little evidence on which to build our judgments and found a balanced approach. Without evidence, risks are exaggerated and the benefits played down. Medical and drug development is undermined, researchers are cautious, monitors without clear and appropriate objectives and as importantly potential research participants ill- or un-informed. We all lose. There is therefore an urgent need for re-evaluation and a coordinated approach to resolve these problems. Our conference will explore the consequences of research, both harm and benefit and look how we might achieve a fair balance that promotes improvements in health care, new medicines without diminishing protection of the research participant. It will also explore the current proposal for an EU Clinical Trial Regulation and its consequences. It will particularly address the approaches of the EU, the EC, competent authorities and drug regulators roles of funders and sponsors how patients, researchers and ethics committees perceive and assess this balance how research risk is monitored how insurance and indemnity is and will be approached in the EU the representation of research risk and benefit in the media For twenty one years the European Forum for Good Clinical Practice has acted as a forum to bring all parties with an interest in health care research together and debate current topics. It has members and partners in all areas of research so this conference will be an opportunity to contribute to the debate, influence policy and practice. Plenary sessions: 1. The approaches of the Competent Authorities: How are regulators and member states approaching risks and benefits assessment? 2. Risk management, insurance and indemnity to include the principles of risk assessments and available tools as well as how brokers approach risk assessment 3. The Joseph Hoet lecture on ethics in clinical research: The Media and Research, Risk and Benefit Dr Trish Groves, Deputy Editor, British Medical Journal (BMJ), United Kingdom 4. The views of patients, researchers and ethics committees when considering harms and benefits. What matters to patients? How do researchers and ethics committees perceive and weigh up this balance? On what should they build their calculus? 5. Harms, benefits, risks and the new EU Clinical Trials Regulations Programme Committee Michael Bone Insa Bruns Hugh Davies Nicky Dodsworth Gerhard Fortwengel Yves Geysels Ingrid Klingmann Olga Kubar Annette Rid Gerald van Roey Florian von Raison Consultant Physician, EFGCP, United Kingdom Central Office of the KKS-Network, Germany Health Research Authority (HRA), EFGCP, United Kingdom Premier Research, EFGCP, United Kingdom University for Applied Sciences and Arts (FHH), Hannover, Germany Quintiles, EFGCP, Belgium Pharmaplex, EFGCP, Belgium Institut Pasteur, EFGCP, Russia King s College London (KCL), London, United Kingdom European Centre for Clinical Research Training (ECCRT), EFGCP, Belgium Novartis Pharma, EFGCP, Switzerland Page 2 of 9

3 Faculty Nicola Bedlington Oana Brosteanu Insa Bruns Christina Bucci-Rechtweg Hugh Davies Christine de Balincourt Katelijne De Nys Lode Dewulf Nicky Dodsworth Jan Geissler Katie Gillies Trish Groves David Haerry Esteban Herrero-Martinez Amanda Hunn Ingrid Klingmann Ruth Ladenstein Denis Lacombe François Lemaire Neil Livingstone Marianne Maman Joerg Meerpohl Monika Pietrek Annette Rid Knut Ruyter Heather Sampson Gabriele Schwarz Cees Smit Janice Soreth Tim Sprosen Daniel Strech Paul Strickland Burkhardt D. Swik Gerald van Roey European Patients Forum (EPF), Belgium Medizinische Fakultät, Zentrum für Klinische Studien Leipzig KKS, Germany Central Office of the KKS-Network, Germany Novartis Pharma, USA National Research Ethics Service (NRES), Health Research Authority (HRA), United Kingdom European Organisation for Research & Treatment of Cancer (EORTC), Belgium UZ Leuven, Belgium UCB, Belgium Premier Research, EFGCP, United Kingdom Patvocates, European Patients Academy on Therapeutic Innovation (EUPATI), Germany Health Services Research Unit, University of Aberdeen, United Kingdom British Medical Journal (BMJ), United Kingdom European AIDS Treatment Group (EATG), Switzerland Association of the British Pharmaceutical Industry (ABPI), United Kingdom Health Research Authority (HRA), EFGCP, United Kingdom Pharmaplex, EFGCP, Belgium St. Anna Kinderkrebsforschung, SIOPe, Austria European Organisation for Research & Treatment of Cancer (EORTC), Belgium Hôpital Henri Mondor, France Bowring Marsh International Casualty, United Kingdom Novartis Pharma, Switzerland German Cochrane Centre, Germany Pietrek Associates, Germany King's College London (KCL), United Kingdom Regional Committees for Medical and Health Care Committees, University of Oslo, Norway University of Toronto, Office of Research Toronto East General Hospital, Canada Federal Institute for Drugs and Medical Devices (BfArM), Germany Vereniging Samenwerkende Ouder- en Patiëntenorganisaties (VSOP), Patients Network for Medical Research and Health (EGAN), The Netherlands Food and Drug Administration (FDA), USA Clinical Trial Support Unit (CTSU), Oxford, United Kingdom Hannover Medical School (MHH), Germany Strickland Quality Assurance, EFGCP, United Kingdom Pharma-Rückversicherung-Gemeinschaft und Probanden-Cover, Germany European Centre for Clinical Research Training (ECCRT), Belgium Page 3 of 9

Lynne Van Poelgeest-Pomfret World Federation for Incontinent Patients (WFIP), The Netherlands Frank Wells Lead Advisor on Research Integrity, Fraud and Misconduct, National Research Ethics Service

Language The language of the Conference will be English. Conference Venue Renaissance Brussels Hotel Rue du Parnasse 19 1050 Brussels, Belgium Tel.: + 32 (0)2 505 29 29 Fax.

4 Lynne Van Poelgeest-Pomfret World Federation for Incontinent Patients (WFIP), The Netherlands Frank Wells Lead Advisor on Research Integrity, Fraud and Misconduct, National Research Ethics Service (NRES), Health Research Authority (HRA), United Kingdom Beat Widler Widler & Schieman, Switzerland Vincent Yeung Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom Conference Language The language of the Conference will be English. Conference Venue Renaissance Brussels Hotel Rue du Parnasse Brussels, Belgium Tel.: + 32 (0) Fax.: +32 (0) Website: Registration & Information conferences@efgcp.eu or visit Social Event On the evening of January 28 th, delegates are invited to take part in the Annual Conference social event which is a very special occasion for networking while finding out more about some typical and cultural landmarks of the hosting city. This year, EFGCP is taking you to the Villa Empain, center for art and dialogue between the cultures of the East and the West to discover this exceptional Art Déco House in Brussels for a privileged moment with a cocktail reception, followed by a guided tour through the current exhibition The Blue Route: Journeys and beauties from the Mediterranean to China and the conference dinner. The Boghossian Foundation and the Villa Empain A space of discoveries, shared feelings and delight, the Villa Empain is also a remarkable heritage of the Art Déco architecture, built in the beginning of the 1930s in the finest materials. This beautiful house is an appropriate place to create and promote a real dialogue between the East and the West. Open since April 2010, this center serves several complementary objectives: cultural, artistic, educational, scientific, as well as activities which can strengthen this dialogue. The Blue Route: Journeys and beauties from the Mediterranean to China This exhibition follows the footsteps of the Silk Road through the colour blue, for centuries inspiring artists, craftsmen and poets, both in the East and West alike. From the Mediterranean to China, this imaginary journey evokes the indigo of textiles, the blue ceramics of the Ottoman Empire and Central Asia, turquoise and lapis-lazuli jewels, culminating with the famous China blue. More than forty modern and contemporary artists have been invited for this journey through space and time, through cultures and art described in its diverse forms of expression. Page 4 of 9

5 Exhibition EFGCP opens the possibility to a limited number of companies to have tabletop exhibits at this event and take advantage of the participation of key stakeholders in the clinical research field to present and promote their activity and added value. Please contact the EFGCP Secretariat at conferences@efgcp.eu for further information. Poster session During this two-day conference, projects/initiatives focusing on risks and benefits of research and related aspects will be showcased on posters. The poster session is organised to give the audience an opportunity to learn about which ongoing activities and interesting approaches on this topic are occurring at the moment. If you or your organisation have undertaken work in any of the areas detailed in the above conference rationale and would be interested in submitting an abstract application, please contact us at conferences@efgcp.eu to receive the detailed call. Support the conference with corporate or institutional sponsoring! EFGCP has decided to open sponsoring opportunities - both corporate with companies and institutional with universities, NGOs and associations - to support this key discussion. Contribute to the success of this event while interacting directly with all major stakeholders involved in clinical research, sharing your opinions with peers and renowned experts, and being among the first to learn about the latest development on the topic! Ask for detailed information to conferences@efgcp.eu. Page 5 of 9

6 Programme Tuesday 28 th January :15 Registration and Welcome Coffee 09:00 Welcome Ingrid Klingmann, Pharmaplex, EFGCP, Belgium 09:05 Introduction: the importance of fair assessment of research consequences Hugh Davies, Health Research Authority (HRA), EFGCP, United Kingdom PLENARY SESSION 1 THE APPROACHES OF THE COMPETENT AUTHORITIES How are Member States regulators approaching risks and benefits assessment? Chairpersons: Annette Rid, King s College London (KCL), United Kingdom & David Haerry, European AIDS Treatment Group (EATG), Switzerland 09:10 Introduction: Risk-adapted research oversight: ethical commentary Annette Rid, King s College London (KCL), United Kingdom 09:30 The approaches of the competent authorities: MHRA Vincent Yeung, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom 10:00 The approaches of the competent authorities: BfArM Gabriele Schwarz, Federal Institute for Drugs and Medical Devices (BfArM), Germany 10:30 The approaches of the competent authorities: FDA Janice Soreth, Food and Drug Administration (FDA), USA 11:00 Questions & Discussion 11:10 Coffee Break PLENARY SESSION 2 RISK MANAGEMENT TECHNIQUES & TOOLS Chairpersons: Nicky Dodsworth, Premier Research, EFGCP, United Kingdom & Cees Smit, Vereniging Samenwerkende Ouder- en Patiëntenorganisaties (VSOP), Patients Network for Medical Research and Health (EGAN), The Netherlands 11:40 Principles of risk assessments and available tools Paul Strickland, Strickland Quality Assurance, EFGCP, United Kingdom 12:00 How do insurance companies approach risk assessment? Burkhardt D. Swik, Pharma-Rückversicherungs-Gemeinschaft und Probanden-Cover, Germany 12:20 Risks/benefits assessment for new forms of clinical research in the era of molecular biology Denis Lacombe, European Organisation for Research & Treatment of Cancer (EORTC), Belgium Page 6 of 9

7 12:40 Questions & Discussion 13:00 Posters Tour and Lunch BREAK-OUT SESSION - WORKSHOPS :15 Workshop 1: What are the true risks of research? What resources and data do we need to develop an evidence base and prevent future harm? Chair: Tim Sprosen, Clinical Trial Support Unit (CTSU), Oxford University, United Kingdom Rapporteur: Monika Pietrek, Pietrek Associates, Germany Workshop 2: Reducing risks in research and health care by reducing dissemination bias. A roadmap discussion Co-Chairs: Daniel Strech, Hannover Medical School (MHH), Germany & Joerg Meerpohl, German Cochrane Centre, Germany Rapporteur: Gerald van Roey, European Centre for Clinical Research Training (ECCRT), EFGCP, Belgium Workshop 3: Insurance future issues within the EU under the proposed Clinical Trial Regulations: what might work? Chair: Katelijne De Nys, UZ Leuven, Belgium Rapporteur: Neil Livingstone, Bowring Marsh International Casualty, United Kingdom 15:45 Coffee Break 16:15 Feedback from Workshops 1-3, Panel and Summary of Ideas Chair: Heather Sampson, University of Toronto, Office of Research Toronto East General Hospital, Canada PLENARY SESSION 3 THE JOSEPH HOET LECTURE ON ETHICS IN CLINICAL RESEARCH Chairperson: Frank Wells, Lead Advisor on Research Integrity, Fraud and Misconduct, National Research Ethics Service (NRES), Health Research Authority (HRA), United Kingdom 16:45 The Media and Research, Risk and Benefit Trish Groves, Deputy Editor, British Medical Journal (BMJ), United Kingdom 17:15 EFGCP Annual General Meeting (for EFGCP Members) 18:30 EFGCP Annual Conference Social Event Page 7 of 9

8 08:30 Welcome Coffee Wednesday, 29 th January 2014 PLENARY SESSION 4 THE VIEWS OF PATIENTS, RESEARCHERS AND ETHICS COMMITTEES WHEN CONSIDERING HARMS AND BENEFITS What matters to patients? How do researchers and ethics committees perceive and weigh up this balance? On what should they build their calculus? Chairpersons: Hugh Davies, National Research Ethics Service (NRES), Health Research Authority (HRA), EFGCP, United Kingdom & Lynne Van Poelgeest-Pomfret, World Federation for Incontinent Patients (WFIP), The Netherlands 09:00 The Patient s view Jan Geissler, Patvocates, European Patients Academy on Therapeutic Innovation (EUPATI) EFGCP, Germany 09:20 Questions & Discussion 09:30 The Researcher s view Ruth Ladenstein, St. Anna Kinderkrebsforschung, SIOPe, Austria 09:50 Questions & Discussion 10:00 The Ethics Committee s view Knut Ruyter, Regional committees for medical and health care committees, University of Oslo, Norway 10:20 Questions & Discussion 10:30 Coffee Break BREAK-OUT SESSION - WORKSHOPS :00 Workshop 4: How should we explain benefit and risk to people deciding whether to join a research project? Chair: Katie Gillies, Health Services Research Unit, University of Aberdeen, United Kingdom Rapporteur: Amanda Hunn, Health Research Authority (HRA), EFGCP, United Kingdom Workshop 5: The ethics related to pregnancy in clinical studies Chair: Lode Dewulf, UCB, Belgium Rapporteur: Christina Bucci-Rechtweg, Novartis Pharma, USA Workshop 6: How to build risk assessment into quality management in clinical trials Co-Chairs: Beat Widler, Widler & Schieman AG, Switzerland & Oana Brosteanu, Medizinische Fakultät, Zentrum für Klinische Studien Leipzig KKS, Germany Rapporteur: Christine de Balincourt, European Organisation for Research & Treatment of Cancer (EORTC), Belgium Page 8 of 9

9 12:30 Lunch Feedback from Workshops 4-6, Panel and Summary of Ideas Chair: Marianne Maman, Novartis Pharma, Switzerland PLENARY SESSION 5 HARMS, BENEFITS, RISKS AND THE NEW EU CLINICAL TRIALS REGULATIONS Chairpersons: Nicola Bedlington, European Patients' Forum (EPF), Belgium & Ingrid Klingmann, Pharmaplex, EFGCP, Belgium 14:00 The European Regulation on Clinical Trials François Lemaire, Hôpital Henri Mondor, France 14:20 Questions & Discussion 14:30 The response of the pharmaceutical industry to proposals Esteban Herrero-Martinez, Association of the British Pharmaceutical Industry (ABPI), United Kingdom 14:50 Questions & Discussion 15:00 The response of academia to proposals Insa Bruns, Central Office of the KKS-Network, Germany 15:20 Questions & Discussion 15:30 Coffee Break CONCLUSIONS 16:00 Open Forum Discussion 16:30 Summary Hugh Davies, Health Research Authority (HRA), EFGCP, United Kingdom 16:40 End of the Conference Page 9 of 9

Striving for Professionalism in IITs

EFGCP Workshop on Striving for Professionalism in IITs 26 & 27 February 2014 Courtyard Hotel, Brussels, Belgium Organised by European Forum for Good Clinical Practice In Collaboration with www.efgcp.eu