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EORTC AISBL / IVZW |
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EORTC AISBL / IVZW |
A permanent Independent Data Monitoring Committee (IDMC) was established in 2001 to review the status of EORTC clinical trials and make recommendations to the Groups concerning trial continuation, modification and/or publication.
Members
Chairman: R. Kaplan, Leeds (GB)
A. Awada, Brussels (BE)
F. Lejeune, Lausanne (CH)
B. Littbrand, Umea (SE)
S. Stenning, London (GB)
R. Sylvester, Brussels (BE) (Ex-officio member)
In accordance with EORTC POL 004, external study specific experts provide advice to the committee
on a confidential basis.
The committee meets on a quarterly basis or according to need. In 2006, seventeen trials were
reviewed while in 2007, seven trials were evaluated.
IDMC review is mandatory for phase III trials where formal interim analyses and early stopping rules
are foreseen and is recommended in the following situations:
• Intergroup trials coordinated by the EORTC
• All trials requiring the randomisation of more than 1000 patients or more than four years of
patient accrual
• Trials with highly toxic regimens or particular safety concerns
• Pivotal phase III trials which will be used for drug registration
• Randomised phase II trials that may continue as a phase III trial without clear rules in the protocol
The IDMC also reviews requests for the early release of data prior to trial maturity.
The Committee’s recommendations are forwarded to the trial management group and to the EORTC
Executive Committee when further action is required.
A general EORTC policy for IDMCs and interim analyses has been established |