© 1998 by Oxford University Press
In a move designed to increase cooperation in cancer research between Europe and the United States, the U.S. Food and Drug Administration has assigned a Drug Master File number to the Treatment Division of the European Organization for Research and Treatment of Cancer, Brussels.
The EORTC's Standard Operating Procedures for the conduct of cancer clinical trials on new treatment modalities and on new drugs are now available to the FDA. The assigned Drug Master File number (DMF 13059) also can be used as a reference by the EORTC's research partners when seeking U.S. approval for treatments tested in Europe.
Trans-Atlantic Network
The Drug Master File and the International Cooperative Project Assurance that was awarded to the EORTC earlier this year by the U.S. Office for Protection from Research Risks (see News June 3, 1998) sets the stage for a joint trans-Atlantic cancer clinical trials network.
"This is a major achievement after more than two decades of close collaboration between the EORTC and the NCI," said Omar Yoder, Ph.D., director of the NCI-Liaison Office in Brussels. He added that the expanded North American/European research network will make use of resources more efficient as well as provide answers to crucial research questions more quickly.
In the past, new treatment modalities that were approved only in Europe often faced further costly and time consuming trials in the United States. This discouraged many European investigators and companies from seeking U.S. approval.
"The Drug Master File will certainly help to facilitate trans-Atlantic cancer clinical research and will encourage our research partners to collaborate further with the EORTC," said Patrick Therasse, M.D., director of the EORTC Data Center.
Equal Footing
The filing of the number with the FDA will put EORTC trial data on an equal footing with data coming from the U.S. National Cancer Institute and its cooperative groups. The NCI, which co-sponsored the submission of the file, will serve as the liaison between the EORTC and the FDA.
The holder of a Drug Master File must comply with the FDA's strict regulations. It must update the Drug Master File regularly and provide an annual list of all individuals and companies authorized to refer to the Drug Master File.
The Drug Master File covers late phase II and phase III trials carried out by the 20 disease-oriented Cooperative Groups of the EORTC Treatment Divison. "I am convinced that this will have a long-term impact on the NCI's trans-Atlantic collaborations," said Yoder.
-- Sabine Steimle
FDA Assigns Drug Master File to European Cancer Group
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