The group established to make recommendations on improving the safety of phase 1 clinical trials, has published its final report at the Science Media Centre in London.
The independent Expert Scientific Group (ESG) was convened by the Secretary of State for Health to examine trials involving new types of drugs, following adverse reactions experienced by participants in the clinical trial of the drug known as TGN1412 earlier this year.
The ESG made twenty-two recommendations, which are expected to have far-reaching implications for those involved in the conduct and safety of first-in-man clinical trials.
They cover a number of key areas:
the need for scientific advice from independent experts before trials of high risk substances are approved
sharing of safety-related information with wider availability of information about unpublished clinical trials and adverse reactions occurring in trials.
the conduct and environment of clinical trials
the clinical trial application process
the skills and future specialist training needs of those conducting clinical trials
the location of trial units and the provision of adequate medical back up in case of problems arising;
Professor Duff, chair of the ESG, said
"The alarming outcome of the TGN1412 trial was unprecedented in the history of clinical trials, and we want to record our sympathy for all of the trial volunteers. Hearing about their experiences was valuable in making our recommendations, and we are grateful to the volunteers who were able to talk to us.
"There is certainly a need to develop new medicines for conditions where current treatment is inadequate but, in clinical trials, the well-being of volunteers must always come first. We believe our recommendations would safeguard this in the future."
Health Minister Andy Burnham thanked the ESG for their hard work and committed to review the recommendations carefully. He said:
"I would like to sincerely thank the Expert Scientific Group and their chairman, Professor Gordon Duff and welcome their recommendations.
"The Northwick Park trial was a tragic incident which has continuing impact on the lives of the volunteers involved in this trial, and their families. We believe that implementing the wide ranging and comprehensive recommendations made in this report could make a significant contribution to improving the safety of clinical trials of high risk drugs such as TGN1412. We will be studying them carefully."
The ESG met a wide range of stakeholders and considered the many written submissions sent to them. These included results of scientific tests from the National Institute for Biological Standards and Control (NIBSC), which may provide potential answers to scientific questions surrounding the adverse reactions to TGN1412.
The Medicines and Healthcare products Regulatory Agency (MHRA) have already implemented recommendations introducing precautionary measures in the approval and conduct of trials in the UK on an interim basis. These interim arrangements will remain in place until they are replaced by European guidance.
Some of the Expert Scientific Group's recommendations, such as those proposing greater sharing of information about trials and adverse reactions, have far-reaching implications. The Government will discuss with relevant stakeholders, including the pharmaceutical industry and academia, how best to ensure that the necessary changes are implemented.
Notes:
1. The full report which details each of the recommendations can be found on the Department of Health website at dh.go.uk
2. The Science Media Centre is a London based independent unit, working to promote the stories and views of the scientific community to the news media when science is in the headlines.
3. The MHRA has also put in place procedures for accessing independent scientific advice, and an expert advisory group that will review applications for trials of high-risk substances will be established in the New Year. Recognising the need for better communication between the main organisations responsible for approval of clinical trials, the MHRA and the UK Ethics Committee Authority (UKECA) jointly published a Memorandum of Understanding on 30 October 2006, setting out details on information sharing between MHRA and research ethics committees in the future.
4. Although the group examined trials involving monoclonal antibodies and the TGN 1412 clinical, trial study has informed the work of the group, the ESG report was not a further investigation into the incident.
5. The new experimental results of scientific tests from the National Institute for Biological Standards and Control (NIBSC), which were used to clarify the toxicity seen in the TGN1412 trial. These may provide potential answers to scientific questions surrounding the adverse reactions to TGN1412 in the clinical trial, and why similar reactions were not detected in pre-clinical testing in animals. These results have been incorporated as a summary section in the report.
6. An interim report was published by the ESG on 25th July 2006, details of which can be found on the DH website here.
7. The members of the ESG are as follows:
Professor Gordon W Duff (Chairman) MA BM BCh PhD FRCP, FRCPE, FMedSci, Professor of Molecular Medicine & Director of Division of Genomic Medicine, Sheffield University
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 L?wer 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 of Rheumatology/Immunology, Imperial School of Medicine, Hammersmith
Professor Herman Waldmann PhD, FRS FRCPath F Med Sci, Professor of Pathology, Sir William Dunn School of Pathology, Oxford
There were 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 (FDA)
Japanese Regulatory Agency
MHRA
For further information please go to:
UK Department of Health
Комментариев нет:
Отправить комментарий