Japanese Journal of Clinical Oncology 2006 36(2):125; doi:10.1093/jjco/hyi239
© 2006 Foundation for Promotion of Cancer Research
Homepage of the Month
Haruhiko Fukuda
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Introduction
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Homepages are redesigned or modified very frequently; therefore, please note that comments in this section are based on the contents of the homepage at the time of writing.
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New European Guideline for Evaluation of Anticancer Products—European Medicines Agency (EMEA) (http://www.emea.eu.int/)
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The European Medicines Agency (EMEA) is a decentralized body
of the European Union with its headquarters in London. The EMEA
is the European counterpart of the US Food and Drug Administration
and the Japanese Ministry of Health, Labour and Welfare. The
EMEA has recently released the new European guideline for evaluation
of anti-cancer drugs, named the Guideline on the Evaluation
of Anticancer Medicinal Products in Man, which will be enforced
in June 2006. The new guideline is available at the website
http://www.emea.eu.int/ (top page
Human Medicines
Guidance
Documents
Efficacy
Approved Guidelines
Efficacy Working Party
Adopted Guidelines
the top of the list).
Concurrently, the Japanese Ministry of Health, Labour and Welfare revised the Guideline for Evaluation of Anticancer Products in November 2005, and this will be enforced in April 2006. So, now you can just compare the regulatory points of view on anticancer drug development between the European Union and Japan. The Japanese guideline consists of 11 pages and the European one 24 pages. There is no large difference in the volume and details on phase I trials between them; however, there are many differences in the phase II and phase III chapters.
The European guideline is generally more detailed, more comprehensive, more practical and more straightforward; therefore, it seems to be an appropriate size for use as educational material for clinical trial methodology in cancer therapeutic development. For example, the European guideline clearly refers to the trial methodology for ‘Non-cytotoxic Compounds’, such as dose-finding schema, several options for randomized phase II design and recommended time-to-event endpoints. The European guideline also gives many recommendations about combination therapy and multimodality therapy, e.g. neoadjuvant (pre-operative) chemotherapy, combination of cytotoxic agents and non-cytotoxic agents, and progression-free survival in non-inferiority trials. In addition, there is an interesting difference in the consideration of ‘double-blinding’. The Japanese guideline encourages ‘double-blinding’ whenever possible and appropriate; the European guideline takes the opposite view, ‘In many cases, a double-blind design is no option due to obvious differences in toxicity between study regimens or due to safety concerns’. Which do you think is the global standard?
The author considers that these interesting differences in the two guidelines may reflect the difference in the expertise and experience of regulatory agencies and pharmaceutical industries between Europe and Japan, especially in terms of the late development of cancer treatment (e.g. combination and multimodality therapies and phase II and phase III trials) because for some time marketing approval in Japan has been based on data from single-agent phase II trials but not from phase III trials. The real-world accumulation of know-how and expertise in cancer drug development should be described as ‘just having started in Japan’ with the new Japanese guideline, which requires phase III trial for marketing approval.
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Introduction
New European Guideline for...