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Expert Group to look into clinical trials

  • Published date:
    25 May 2006

Health Minister Andy Burnham today announced the membership of an Expert Group to investigate clinical trials to the House of Commons. The Chair of the group, Prof Gordon Duff, was appointed in April following the adverse reaction of six Parexel clinical trial participants to the drug TGN1412.  

Revealing the eighteen other members of the group, Andy Burnham said

'This is a complex scientific issue which raises important questions about the potential risks associated with this type of drug.  That is why Secretary of State agreed to the establishment of an Expert Working Group.

'Clinical trials in general have an excellent safety record, but monoclonal antibodies are a relatively new type of biological drug.  The Expert Group will provide advice for the future authorisation of trials involving these types of products.'  

The Expert Group is an independent scientific committee that will determine its own work programme in relation to the Terms of Reference, which are:

To consider what may be necessary in the transition from pre-clinical to first-in-man Phase 1 studies, and in the design of these trials, with specific reference to:

  • biological molecules with novel mechanisms of action;
  • new agents with a highly species-specific action;
  • new drugs directed towards immune system targets.

The group will produce an interim report within three months of starting work. It is proposed that the minutes of the meetings to date and interim findings should be made public at that point.

The expert group will be taking evidence from a range of stakeholders and experts, but will also welcome submissions from others who feel they may have a contribution to make on this important issue. These should be emailed to Department of Health - if possible before end of June 2006 at:

ExpertGroupResponses@dh.gsi.gov.uk

Notes to editor

1. A written ministerial statement was laid in the House of Commons on 25 May 2006.

2. This Expert Group which held it's first meeting on Tuesday 23 May will focus on the scientific issues arising from the TGN1412 incident and, in particular, questions arising about the implications of potential actions of such substances for future clinical trial design.

3.  The members of the group are as follows;

  • Professor Gordon W Duff  MA BM BCh PhD FRCP, FRCPE, FMedSci; Professor of Molecular Medicine & Director of Division of Genomic Medicine, Sheffield University: CHAIRMAN
  • Professor John I Bell MA DM FRCP FMedSci; Regius Professor of Medicine, Oxford University
  • Professor Dame Carol M Black CBE MD FRCP FMedSci; President of the Royal College of Physicians of London and Professor of Rheumatology, Royal Free Hospital, London
  • Professor Sir Leszek K Borysiewicz  MB BCh FRCP F Med Sci; Deputy Rector, Imperial College London
  • Professor Janet H Darbyshire OBE MB ChB  FMedSci FRCP FFPH;  Director of the MRC Clinical Trials Unit, Co-Director of UK Clinical Research Network and Professor of Epidemiology, Royal Free and University College London Medical School.
  • Professor Neva E Haites OBE MB ChB PhD MRCPath FRCPE; Professor of Clinical Genetics & Head of College and Vice-Principal, College of Life Sciences and Medicine, University of Aberdeen
  • Sir Bob Hepple QC FBA; Cambridge University and Chair of the Nuffield Council of Bioethics
  • Ms Amanda Hoey; Director, ConsumerHealth Consulting Ltd - Lay representative
  • Dr Stephen C Inglis BSc PhD; Director, National Institute for Biological Standards and Control (NIBSC)
  • Professor Lars Klareskog; Professor of Rheumatology, Karolinsha University, Stockholm
  • Professor Robert Lechler MB, ChB, PhD, FRCP, FRCPath, FMedSci; Vice-Principal (Health), King College London
  • Professor Dr Johannes Löwer  MSc, MD; President of the Paul Ehrhlich Institute, Langen, Germany. 
  • Professor Andrew J McMichael MB BChir PhD CNAA FRCP FRS; Professor of Immunology, Oxford University
  • Professor Alexander F Markham BScPhD MB BS DSc FRCP FRCPath; Chief Executive Cancer Research UK and Professor of Medicine, St James University Hospital, Leeds
  • Professor B Kevin Park BSc PhD Hon MRCP FMedSci; Professor of Pharmacology & Head of Department of Pharmacology and Therapeutics, Liverpool University.
  • Mrs Vivienne Parry; Lay representative
  • Professor Munir Pirmohamed MC ChB PhD FRCP
  • Professor of Clinical Pharmacology, Liverpool University
  • Professor Mark J Walport MB BChir MA FRCP FRCPath F Med Sci; Director of the Welcome Trust
  • Professor Herman Waldmann  PhD, FRS  FRCPath F Med Sci; Professor of Pathology, Sir William Dunn School of Pathology, Oxford

OBSERVERS; there will be a number of observers to the expert group from:

  • The European Medicines Agency
  • Department of Health
  • Department of Trade and Industry - Biosciences Unit
  • US Food and Drug Administration
  • Pharmaceutical and Medical Devices Agency, Japan
  • MHRA

*Agency of the German Government responsible for the regulation of biological medicinal products for humans and animals.

  • Contact:
    Department of Health
  • Phone:
    Public enquiries
    020 7210 4850

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